cyrilzakka/clinical-trials huggingface dataset:
Acetaminophen and Social Processes

Recent research has identified heightened sensitivity to social rejection as a core feature of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious behaviors characteristic of the disorder.

Therefore targeting therapy towards the reduction of rejection sensitivity may improve the low rates of effectiveness of current pharmacological and behavioral therapies. Therefore, this proposal tests a theoretically-based pharmacological approach that specifically targets the heightened sensitivity to rejection experienced by BPD patients.

In prior research with normal controls, it was shown that chronic treatment with the physical pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection (using fMRI) as well as self-reported feelings of rejection in a daily diary study.

It is the aim of this research project to determine if the over-the-counter analgesic, acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD patients. The goal of this proposal is to use an open-label design to determine if acetaminophen improves symptoms in BPD patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of borderline personality disorder
* 18 years or older
* if on psychiatric medication, must be on a stable dose
* able to swallow tablets

Exclusion Criteria:

* current, primary substance abuse, particularly alcoholism
* current eating disorder
* history or current psychotic disorder
* suicidal ideation or behavior requiring imminent inpatient treatment
* pregnancy
* Participants whose medication has not been stable for more than 4 weeks
* Impaired liver function (\> 1.25x the upper limit of the reference range)
* Conditions that can affect immune system functioning.
Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor

SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor.

SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor. The objective of this phase 1 study is to evaluate the safety and tolerance of SHR1459 in patients with replaced/refractory mature B cell neoplasms, in order to determine the maximum tolerated dose (MTD) and recommended dose for phase 2 clinical study (RP2D);

Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status \[PS\] score must be 0 or 1;
* Life expectancy ≥ 12 weeks;
* Mature B cell eoplasmss with histological or cytological diagnosis, including diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) , chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) and waldenstrom macroglobulinemia (WM);
* The function of bone marrow is basically normal;
* Renal function is basically normal;
* Hepatic function is basically normal.

Exclusion Criteria:

* Had received treatment with the compound of the same mechanism (BTK inhibitor);
* With infiltration of lymphoma central nervous system;
* Received autologous stem cell transplantation within 60 days before signing the informed consent, received allogeneic stem cell transplantation in 90 days (after allogeneic stem cell transplantation, if graft-versus-host disease appeared, it must be ≤ level 1, and if there was no prohibited medication, the screening could be performed);
Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.


Eligibility Criteria:
Inclusion Criteria:

* Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
* Have a clear chest X-ray at the Entry visit
* Negative urine pregnancy test at the Entry
* Continue treatment on methotrexate

Exclusion Criteria:

* Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
* Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
* At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
* NYHA (New York Heart Association) Class III or IV congestive heart failure
* Current or history of tuberculosis
* History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
* History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
* High risk of infection
* Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
Safety Study of OPC-12759 Ophthalmic Solution

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Exclusion Criteria:

1. Presence of ocular disorder
2. Intraocular pressure of 21mmHg or higher
3. Corrected visual acuity of less than 1.0
4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
5. History of refractive surgery
6. History of other ocular surgeries within 12 months
7. Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation

This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).

Randomised open-label cross-over trial of 52 healthy adult volunteers comparing two ivermectin formulations: the standard tablet formulation, and a newly developed infant formula preparation. Participants will be randomised to receive one of these two formulations at the start of the trial and after a 21 day wash out period will be given the alternative formulation. Blood samples will be taken to determine serum drug concentrations. The bioequivalence, tolerability and drug-related adverse effects will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged over 18 years up to 55 years; and
* Body mass index of 18.0 - 32.0 kg/m2 with body weight ≥ 50.0 kg; and
* Medically healthy, determined by medical history, physical examination, no clinically significant abnormalities on baseline blood tests, vital signs (blood pressure, oxygen saturation and heart rate) as deemed by the study Doctor; and
* Females must be non-pregnant, non-lactating or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing; and
* Sexually active, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to study until end of study; and
* Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until end of the study; and
* Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient period and outpatient visits for the duration of the study; and
* Good venous access on at least one arm as assessed by study staff.

Exclusion Criteria:

* History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the study doctor; or
* Known allergy to ivermectin or taking a drug that interacts with ivermectin via the P-glycoprotein transport system (e.g. amiodarone, carvedilol, clarithromycin, clotrimazole); or
* Currently taking warfarin; or
* Known lactose intolerance or cow's protein intolerance; or
* Known elective surgery scheduled within the next 3 months; or
* Inability to comply with the study protocol.
Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults

The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.

The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.


Eligibility Criteria:
Inclusion Criteria:

* participants aged 65 and over
* classified as pre-frail according to SHARE-Frailty Instrument
* independent of movement and activity
* able to perform Mini-Mental Status Examination (MMSE) score ≥24

Exclusion Criteria:

* severe contraindications for physical exercise
* central nervous system impairments
* inability to speak and understand Greek properly
* a cognitive state that prevents understanding the researcher's instructions
Effect of Attentional Therapy on Post-traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is associated with an attentional bias towards negative stimuli, which is supposed to contribute to the development and the maintenance of the disorder. We recently showed using eye-tracking evidenced two types of AB towards negative stimuli: a "physiological AB" found both in healthy and individual with PTSD, characterized by a stronger initial attentional engagement towards negative stimuli compared to neutral stimuli, as revealed by longer first fixation duration dwell time on negative pictures than on neutral pictures; a "pathological bias" observed only in individuals with PTSD and characterized by an heightened sustained attention towards negative stimuli once detected, which further increases with prolonged exposure. The present study aimed at assessing the effectiveness of an eye-tracking assisted attentional bias reduction therapy, targeting specifically the pathological bias on the reduction of PTSD symptoms


Eligibility Criteria:
Inclusion Criteria:

* Understanding and able to express themselves in French
* Giving informed consent, by dating and signing the study participation form
* Having health insurance coverage
* Normal or corrected to normal vision and hearing
* DSM-5 PTSD criteria, assessed using the CAPS and PCL-5

Exclusion Criteria:

* Minors or adults under guardianship, under judicial protection, persons deprived of liberty
* Pregnant or breastfeeding women
* Refusal to participate after being clearly and fairly informed about the study
* Sensory, visual or auditory incapacity to participate in the study
* Personal history of neurological disorder or current neurological disorder
* Use of drugs other than tobacco and alcohol
* Alcohol use on the day of experimentation
* Personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma and stress disorders assessed at clinical interview and with MINI
* Personal history of multiple trauma in childhood
* Psychotropic medication treatment not stabilized over the past 4 weeks
* MOCA \< 26
* Contraindication to prolonged exposure therapy
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years old
* HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
* Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria:

* Pregnant women
* Decompensated liver disease
* Combination infection of HCV, HAV, or HEV
* Combination infection of HIV
* Any contraindication of interferon α
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem

Exclusion Criteria:

* Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
Digital-technology Based Interventions on Treatment of Migraine.

The main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy).

Aims and purpose:

The main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy).

Sub-aims:

To evaluate the effectiveness of interventions based on digital technology and their impact on the quality of life, comparing them with the interventions or treatment standards performed by ordinary specialists.

Assess the applicability and accessibility of digital technology-based interventions in the healthcare system against a treatment standard.

Determine the profile of patients (demographic and clinical indicators). Identify restrictions on the use of digital interventions. Evaluate patient compliance, non-specific treatment factors such as therapeutic relationship, and treatment credibility against the treatment standard.

Evaluate patient satisfaction with treatment methods and impact on treatment outcomes.

Assess the satisfaction of professionals with the implementation of a digital multidisciplinary treatment platform in patients.

Assess the use and generalization of digitally acquired skills in everyday practice.

Determine if and how much clinical contact is needed for digital-based interventions to be effective.

Evaluate cost-effectiveness against the standard of treatment. Assess the willingness to pay for the use of an effective headache treatment platform.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed migraine, frequent episodic, headache days a month 8-14 days;
2. patient age 18-64 years;
3. very good command of the Estonian language both orally and in writing.

Exclusion Criteria:

1. headaches lasting less than 8 days and more than 14 days per month;
2. all other primary and/or secondary diagnoses of headache;
3. under the age of 18 or over 64;
4. currently severe depression;
5. psychotic disorders;
6. pregnancy and lactation;
7. severe somatic disease;
8. severe organic mental disorders;
9. other chronic pain;
10. addictive disorders.
Comparison of Two Gelatine Solutions

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.


Eligibility Criteria:
Inclusion:

* Male or female patients \>= 18 years of age and \<= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
* Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
* Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

* Patients of ASA-class \> III
* Known hypersensitivity to gelatine or to any of the constituents of the solution
* Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
* Patients on hemodialysis
* Patients suffering from decompensated renal function (i.e. serum creatinine \> 3.0 mg/dl)
* Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) \> 150 mmol/L) Hyperchloremia (serum(Cl-) \> 110 mmol/L)
* Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
* Lactation period
* Simultaneous participation in another clinical trial
* Emergencies
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.

This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

Patients (n=70) with long-term (\>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.

Eligibility Criteria:
Inclusion Criteria:

* Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
* Willing and able to give informed consent for the intervention

Exclusion Criteria:

* Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
* Patients with complete heart block and no reprogramming options
Impact of Plant Diet for Diabetes Prevention

The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.

Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index greater than or equal to 27
* High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
* Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
* Physical activity below national guidelines
* Aged 30-55 (premenopausal for women)
* Following a Western diet

Exclusion Criteria:

* Diabetes diagnosis
* Take medications that may affect insulin sensitivity
* More than 5% weight change within 6 months of screening
* History of bariatric surgery
* Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
* Take hormone replacement therapy
* Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
* Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine
Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Exclusion Criteria:

* Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
* Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.