cyrilzakka/clinical-trials huggingface dataset:
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not be screened. Subjects who have signed the informed consent form will be enrolled in Study KD025-217 if they have met 1 of the following conditions:

* Actively receiving belumosudil or in long-term follow-up (LTFU) in Study KD025-208 or Study KD025-213
* Enrolled in the Companion Study as specified in Study KD025-213 Amendment 2 and received at least 6 months of treatment or is in LTFU

Approximately 20 Study Centers will participate with approximately 70 subjects participating overall.

Eligibility Criteria:
Inclusion Criteria:

Subjects must have been treated with belumosudil for at least 1 of the following:

* Actively receiving belumosudil on Study KD025-208 or Study KD025-213
* Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs.
* Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU

Exclusion Criteria:

* Female subject who is pregnant or breastfeeding
* Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.

As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
2. patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis.
3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative

Exclusion Criteria:

1. previous history of antiviral therapy
2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
3. positive for anti-HCV or anti-HIV
4. Child-Pugh classification B or C after surgery
5. preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds
6. signs showing recurrence or metastasis oen month after surgery
7. underlying cardiac or renal diseases
Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation

The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.

Post-Traumatic Stress Disorder (PTSD) is characterized by intrusive and persistent memory of past result from an event causing or able to cause death, be a threat of death, a severe injury or constitute a threat for physical integrity. It is a frequent disorder in general population (8%). In France, The most frequent traumatic events causing PTSD are serious accidents, rape, physical assaults, violence, etc. PTSD treatment involves antidepressant and cognitive and behavioural psychotherapy, which encourage exposure to elements that remind the trauma (memories, circumstances), with the objective of reducing the fear associated with the traumatic memories. Innovative therapeutic strategies aim to improve the psychotherapeutic effect with enhancement drugs or using neuromodulatory techniques, such as repeated transcranial magnetic stimulation (rTMS).

The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* PCLS score \>40
* Able to give his written informed consent
* Not participating another study
* Affiliation to a social security system
* Having a PTSD for 3 months
* No treatment modification for 4 weeks (Psychotropic treatment or structured psychotherapy)

Exclusion Criteria:

* Partially deaf with equipment
* people with identified neurological disease
* people with addiction to psychoactive substance
* people who can't conform to tests
* people having a contraindication for rTMS (cochlear implant )
* people suffering from chronicle or acute delusional disorder
* any circumstances making the people unable to understood nature, aim or consequences of the study.
A Study to Learn About How a New Pneumococcal Vaccine Works in Children

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.

Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.

At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* Have received 3 infant doses of 20vPnC at 2, 4, and 6 months of age, with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
* Major known congenital malformation or serious chronic disorder.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion

To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

Eligibility Criteria:
Inclusion Criteria:

* DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
* age 18 years and older
* desiring Paragard or Mirena intrauterine device insertion

Exclusion Criteria:

* Current pregnancy
* cervical stenosis
* severe medical illness
* known allergy or sensitivity to lidocaine or naproxen
* peptic ulcer disease
* current pelvic inflammatory disease
* patients with known renal insufficiency
* patients using chronic NSAIDs or on chronic pain medication
* women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC
Effect of Peng Block Application on Inflammation and Mortality in Hip Fractures

In this study, the investigators the effect of PENG block on SIRI (systemic inflammation response index) and 30-day mortality in geriatric patients(over 65 years old) undergoing hip surgery, and the effect on the length of hospital stay.

Patients over the age of 65 who are scheduled for surgery due to hip fracture will be included in the study. According to the power analysis, a total of 60 patients will be included in the study. Patients will be divided into 2 groups by randomization.Multimodal analgesia will be applied to both groups. The first group will receive preoperative PENG block and the other group will not receive an analgesic block and will receive paracetamol and tramadol hydrochloride analgesia. All patients received spinal anesthesia using 10 mg bupivacaine. Preoperatively, IL-6, CRP, and hemogram tests will be performed on all patients and then these tests will be repeated 4, 24, and 48 hours after the surgical stimulus.

At the end of the operation, total bleeding amounts, blood products and amounts given, and operation time will be recorded. Postoperatively, NRS scores, initial analgesic requirements, hospital stays, and 30-day mortality will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3 score
* Hip Fracture Surgery

Exclusion Criteria:

* Refusal to participate in the study
* ASA score of 4 and above
* Obesity (BMI \>40)
* Failure of spinal block
* Switching to general anesthesia
* Patients undergoing revision surgery
* Patients with multitrauma
* Patients with old fractures (\>3 weeks)
* Patients receiving preoperative and intraoperative sedation
* Patients with active malignancy receiving RT, KT
* Patients with active infection, patients receiving antibiotic treatment
* Patients with contraindications for regional anesthesia techniques
* Patients receiving chronic treatment with steroids or immunosuppressants
* Patients using anti-inflammatory drugs
Measurement of Multiphysical Fields at the Subject-sitting Interface

With the population ageing and the increase in disabilities prevalence, demand for wheelchairs is increasing. Padding and shape of seat are important factors for comfort when sitting for long periods of time. Sustained mechanical loads induced by the seated stance can cause pressure ulcers in the ischial prominences. Temperature and humidity have also been shown to be important in the development of pressure ulcers.

The aim of this research is to measure the pressure, temperature and relative humidity fields at the user-seat interface of a wheelchair.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* aged of 18 and more
* agreeing to participate in the study

Exclusion Criteria:

* under 18 years old
* pregnant women
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD

This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).

This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials.

This study consists of:

* A phone/video interview to provide e-consent and medical history
* A single home health visit to collect blood sample for antibody testing
* A phone/video call for communication of AAV8 antibody test results

Eligibility Criteria:
Inclusion Criteria:

* Males at least 0 to \<12 years of age
* Diagnosis of DMD
* Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements

Exclusion Criteria:

* Prior participation in a gene therapy trial OR recipient of a gene therapy drug
* Other inclusion/exclusion criteria apply
MAGZEN® Effect on Recent Anxiety Reaction

Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.

107 patients suffering from recent anxiety reaction will be included in the study. They will be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.

Eligibility Criteria:
Inclusion Criteria:

* patient suffering from recent anxiety reaction
* Hamilton-anxiety score ≥ 20 at inclusion
* recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment

Exclusion Criteria:

* major depressive syndrome
* anxiety disorders more than 3 months
* anxiety due to death
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure

This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.

According to the literature, cyanoacrylate adhesives (topical skin adhesive) have performed as intended and have not produced results that would bring into question the safety or effectiveness of cyanoacrylate adhesive for closure of surgical incisions and traumatic wounds in humans.

As such, this is a multicenter, prospective, randomized controlled study for the purpose of comparing two forms of topical skin adhesives, DERMABOND PROTAPE \& DERMABOND HVD for closure of wounds in the Emergency Department.

Patients presenting in the Emergency Department with traumatic wounds meeting the acceptance criteria will have their wounds closed with DERMABOND PROTAPE or DERMABOND HVD, and will be monitored and evaluated at 14 \& 30 days.

Eligibility Criteria:
Inclusion Criteria:

* at least 1 year of age
* in good general health in the opinion of the Investigator.
* have at least one traumatic wound meeting the criteria for closure as defined in current Dermabond product labeling.
* patient must be willing to follow instructions for wound care listed in device labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed.
* patient agrees to return for follow-up evaluation
* patient (or guardian) signs the informed consent
* patient is reasonably expected to survive the study

Exclusion Criteria:

* significant multiple trauma (merely multiple wounds are allowed)
* peripheral vascular disease
* insulin dependent diabetes mellitus
* known to have a blood clotting disorder
* receiving antibiotic therapy for preexisting condition or infection
* known to be HIV-positive or otherwise immunocompromised
* known personal or family history of keloid formation or hypertrophy
* currently taking systemic steroids
* known allergy to cyanoacrylate, formaldehyde, tapes or adhesives
* participating in another current clinical study
* history of abnormal wound healing
* burst stellate lacerations due to a crush or hard blow
* animal or human bite or scratch
* decubitus ulcer
* puncture wound
* wound at mucocutaneous junction or in mucosal (but not excluding the vermillion border of the lip)
* wound on scalp covered by natural hair
* wound has visual evidence of active infection
* gangrenous wound
* wound requiring debridement of devitalized or contaminated tissue
* wound at site of active rash/skin lesion making evaluation difficult
* previously treated wound or has failed to heal
* wound in high skin tension area or across an area of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application
A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients


Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants:

   1. Aged 18 to 45 years,
   2. Weight 50 to 120 kgs,
   3. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
   4. No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.
2. Atopic dermatitis:

   1. Aged 18 to 75 years,
   2. body mass index (BMI): 18.0 - 32.0 kg/m2,
   3. Atopic Dermatitis (AD) for 1 year or longer at Baseline,
   4. Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
   5. Investigator Global Assessment (IGA) of 3 or 4 at baseline,
   6. AD involvement of 10 percent or more of body surface area at Baseline,
   7. Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
   8. Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.

Exclusion Criteria:

1. History of relevant drug allergies.
2. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
3. Healthy participants:

   1. History of alcohol abuse or drug addiction within 1 year before screen,
   2. Positive drug and alcohol screen at screening.
4. Atopic dermatitis:

   1. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment:
   2. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients

1. Ethical committee approval is obtained from ethics committee of Faculty of Pharmacy, Damanhour University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Forty female patients with newly diagnosed breast cancer who are candidates for will be recruited from Damanhour oncology center.
4. All enrolled patients will be randomly assigned into two arms:

   * Control arm (n=20): will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 4 cycles (12 weeks) after receiving 4 cycles of Adriamycin and cyclophosphamide (AC) protocol
   * Treatment arm (n=20): will receive the same regimen as control arm in addition to Coenzyme Q10 400 mg daily (200 mg twice daily).
5. All patients will be submitted to:

   * Full patient history and clinical examination.
   * Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).
   * Assessing the effect of coenzyme Q10 on the following: fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, Anemia , febrile neutropenia and pruritis using common terminology criteria for adverse event (NCI-CTCAE) version 5.
   * Assessing of the patient's QoL by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTx) subscale

Eligibility Criteria:
Inclusion Criteria:

1. women with newly diagnosed breast cancer r ≥18 years old.
2. Naive to chemotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2

Exclusion Criteria:

1. Advanced liver disease (defined as liver enzyme elevation \>3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an estimated glomerular filtration rate (eGFR) \<60 ml min-1 1.73 m-2).
2. Patients with a history of allergy to Coenzyme Q10 and similar compounds.
3. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
4. Pregnancy or breast feeding.
5. hereditary muscle disorders.
Drug Delivery Devices for Osteomyelitis

Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* The retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis.

Exclusion Criteria:

* Other kinds of osteomyelitis.