cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
* Moderate to severe SLE disease activity
* Evidence for at least 1 of the following SLE markers:

  * Anti-dsDNA antibodies confirmed by central laboratory or
  * Low complement confirmed by central laboratory or
  * Antinuclear antibody (ANA) titer of \>= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory
* The subject is receiving stable SLE standard-of-care medication

Exclusion Criteria:

* Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
* Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
* New or worsening Class III or IV lupus nephritis
* Chronic kidney failure stage 3b
* Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
* Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
* Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
* Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
* History of thromboembolic events within 12 months of screening
* Subject has used protocol defined prohibited medications
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis

Low back pain may be reduced after cervical spinal surgery

The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* all patients with cervical myelopathy and low back pain

Exclusion Criteria:

* previous surgery at the lumbar spine
* malignancy
* previous surgery at the cervical spine
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.

Many studies have shown that prior HSV-2 infection is associated with an increased risk for HIV infection. Acyclovir is the most widely studied and clinically utilized antiviral for the suppression of HSV-2 infection. This study will evaluate the efficacy of twice-daily dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes. For this study, WSM will be enrolled in Lusaka, Zambia; Harare, Zimbabwe; and Johannesburg, South Africa; MSM will be enrolled in Lima and Pucallpa, Peru; Seattle, Washington, USA; New York City, New York, USA; and San Francisco, California, USA.

Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms. The first arm will receive 400 mg acyclovir twice daily; the second arm will receive placebo. Follow-up visits will occur monthly. Participants will be tested for STDs, including HIV and syphilis, at each visit and treated as necessary; participants will also be given adherence and condom counseling, risk behavior and sexual history questionnaires, and genital symptoms questionnaires at all study visits. Medical history will be assessed and participants will undergo blood work at Months 3, 6, 9, and 12.

Eligibility Criteria:
Inclusion Criteria For All Participants:

* HIV-uninfected
* HSV-2 infected
* Plans to stay in the area for the duration of study participation
* Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information

Inclusion Criteria for MSM:

* At least 1 episode of anal intercourse with another man within 6 months of study entry

Inclusion Criteria for WSM:

* At least 1 episode of unprotected vaginal sex within 6 months of study entry

Exclusion Criteria For All Participants:

* Current enrollment in another HIV vaccine or prevention trial
* History of adverse reaction to acyclovir
* Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
* Known plans for travel away from study site for more than 2 months

Exclusion Criteria for MSM:

* In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
* Reported sex at birth as female

Exclusion Criteria for WSM:

* Pregnancy at screening or enrollment
RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r T-ALL/LBL.
3. CD7 positive expression
4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
6. Left ventricular ejection fraction ≥ 50% .
7. Baseline oxygen saturation ≥ 92% on room air.
8. ECOG performance status of 0 to 2.
9. The estimated survival time is more than 3 months.
10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
2. Isolated extramedullary lesions
3. Subjects with some cardiac conditions will be excluded.
4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade CNS3.
5. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
6. History of malignancy other than non-melanoma skin cancer or carcinoma.
7. Primary immune deficiency.
8. Presence of uncontrolled infections.
9. Sujects with some anticancer therapy before CAR-T infusion will be excluded.
10. Active uncontrolled acute infections.
11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
12. Subjects who are receiving systemic steroid therapy prior to screening.
13. Subjects with acute graft-versus-host disease (GvHD)
14. Having received live/attenuated vaccine within 4 weeks prior to screening.
15. History of allergy to any component of the cell therapy product.
16. Pregnant or breastfeeding women
17. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients

A panel of highly sensitive circulating biomarkers for acute liver injury have been identified and demonstrated to identify liver injury on first presentation to hospital before standard tests are elevated in patients with paracetamol overdose. The investigators wish to test these biomarkers in patients with active and latent tuberculosis to see if they can be used to stratify patients undertaking anti-tuberculosis drug therapy. Anti-tuberculosis drug induced liver injury is the most frequent side-effect of anti-tuberculosis therapy, affecting 2-5% of tuberculosis patients seen at the Royal Infirmary Edinburgh and hindering their effective treatment. Patients will be recruited from the TB out-patient clinic at the Royal Infirmary Edinburgh. Blood samples will be taken every time the patient visits the clinic and also retrieved from the biochemistry lab. The biomarkers in the blood samples will be analysed to determine if they rise in patients who develop liver injury.

To improve patient stratification, the investigators have developed a panel of novel circulating liver specific and mechanistic biomarkers that report early acute liver injury. Such biomarkers are needed as current early biomarkers of liver injury lack sensitivity and specificity. The panel of biomarkers either have enhanced liver specificity or provide mechanistic insights. Currently, antituberculosis drug-induced liver injury (ATDILI) is the most frequent side-effect of anti-tuberculosis therapy and this hinders the effective treatment of TB, as it means that treatment regimens are not completed. At present, the risk of ATDILI means that monitoring of liver function is required, with levels of ALT measured monthly. If levels of ALT rise to 2-5x the upper limit of normal levels (ULN) and the patient is unwell the frequency of monitoring is increased to biweekly monitoring. Antibiotic therapy is only changed if levels of ALT remain greater than 3xULN, the patient continues to display symptoms and there is a positive causality assessment that the anti-tuberculosis drugs are causing ATDILI. This project will recruit patients taking antituberculosis drugs and determine the diagnostic and prognostic value of the biomarker panel, in relation to liver injury as a result of anti-tuberculosis therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing treatment for tuberculosis
* Patients with the capacity to give consent

Exclusion Criteria:

* Patients unable to give informed consent
* Patients who refuse to take part
* HIV positive patients
Screening for Studies on Nystagmus and Strabismus

This screening protocol is designed to help recruitment patients for National Eye Institute (NEI) studies on nystagmus and strabismus. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program.

Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a nystagmus or strabismus study. These include routine laboratory tests, non-invasive imaging, questionnaires, and other standard tests. If needed, a test called oculography may be done to record eye movements. There are two procedures for recording and documenting these movements. In the infrared system, the patient wears a pair of glasses or goggles and looks at a red light while the head is kept steady. In the search coil system, the eye is numbed with anesthetic eye drops and a soft contact lens is placed on the eye. Then the patient looks at a red light while the head is held still. Each oculography session lasts 20 to 30 minutes. Photographs of the eye may be taken.

When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible and wish to participate in National Eye Institute (NEI) clinical research studies.

Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk. Once the screening process is completed and their eligibility assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor or referring physician.

Eligibility Criteria:
* INCLUSION CRITERIA

Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened.

In addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study.
Exercise and Pain Sensitivity in Knee Osteoarthritis

A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability.

While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms.

It is hypothesized that in knee OA patients exercise reduces the pain sensitivity


Eligibility Criteria:
Inclusion Criteria:

* Age above 40 years
* Clinical diagnosis of tibiofemoral osteoarthritis
* Radiographic verification of diagnosis (Kellgren\&Lawrence 2 or 3)
* Ability to participate in examinations
* Ability to participate in exercise sessions
* 20≤ Body Mass Index (BMI) ≤35 kg/m2
* Ability to comply with rules about concomitant medication and therapy
* Speak, read and write Danish

Exclusion Criteria:

* Participation in exercise training for the knee osteoarthritis within 3 months of enrollment
* Counterindications for exercise
* Pregnant or breastfeeding
* Current or previous autoimmune disease
* History of surgical joint replacement in the lower limbs
* Planned surgery
* Current or previous diagnosis or signs of cardiovascular disease
* Neurological disorders
* Alcohol or drug abuse
* Diabetes
* Psychiatric disorders
* Regional pain syndromes
* Regional pain caused by lumbar or cervical nerve root compression
* Counterindications to MR scan
* Counterindications to MR contrast
The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.


Eligibility Criteria:
Inclusion Criteria:

* PBC patients living in Switzerland

Exclusion Criteria:

-
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery

The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).

Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.

This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.

Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient who has read and signed the informed consent form for participation in the study
* Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation

Exclusion Criteria:

* Known or detected diaphragmatic dysfunction before the intervention
* Patient not affiliated with the French social security system
* Patient under legal protection, guardianship, or curatorship
* Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
* Patient in an exclusion period from a previous clinical study
* Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol
Ideal Sedation for Stroke Thrombectomy

The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of symptoms
* Clinical equipoise for best mode of sedation

Exclusion Criteria:

* Any known allergy to either proposed medication and its alternative
* Any patient that has been intubated prior to randomization
* Posterior circulation strokes
* Age ≤ 18
* Pregnant female
Use of Fitbits During Breathing Meditation

This study will examine short breathing meditations paired with Fitbit technology in order to assess mindfulness and track physical activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Currently a student, faculty, or staff member at university where research is being completed.
* Able to wear a Fitbit close to 24 hours a day for two weeks.

Exclusion Criteria:

* Younger than 18 years.
* Has previously practiced meditation.
Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)

The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual \[CAU\]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic insomnia
* impaired quality of sleep (Insomnia Severity Index Score ≥ 10)

Exclusion Criteria:

* none
Toric Contact Lens Digital Performance and Comfort Study

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Eligibility Criteria:
Inclusion Criteria:

* 18 to 39 years of age (inclusive)
* pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
* Current/established full time (\>6 days week, \>8 hours/day) soft contact lens wearer
* Best corrected acuity of 20/25 or better in each eye
* Self-report of at least 4 hrs/day using digital devices
* Willing to wear lenses at least 8 hours each day during the study period
* Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Enclusion Criteria:

* History of ocular pathology or surgery
* Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
* Gas permeable lens wear for at least 3 months
* Symptomatic soft contact lens wearer (CLDEQ-8 score \<12 at baseline)