cyrilzakka/clinical-trials huggingface dataset:
Vamikibart in Participants With Uveitic Macular Edema

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
* Diagnosis of macular edema associated with non-infectious uveitis (NIU)
* Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
* BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

Exclusion Criteria:

* Evidence of active or latent syphilis infection
* Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
* Serious acute or chronic medical or psychiatric illness
* History of major ocular and non-ocular surgical procedures
* Uncontrolled IOP or glaucoma or chronic hypotony
* Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
* Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
* Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
* Topical corticosteroids and/or topical NSAID \> 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
* Diagnosis of macular edema due to any cause other than NIU
* Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Swalqol in Primary Hyperparathyroidism

Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism.

Patients who will undergone parathyroidectomy for primary hyperparathyroidism will be included in the study. Swal-Qol and Sf-36 forms will be used for evaluation of quality of life before and 1 month after the surgery. The change in the quality of life and swallowing related quality of life will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* no diagnosis of Alzheimers disease
* must be able to swallow tablets Planned operation for primary hyperparathyroidism

Exclusion Criteria:

* secondary or tertiary hyperparathyroidism
* insulin dependent diabetes
* thyroid disease
Effect of Azithromycin on Fatty Acids in CF

In collaboration with Dr.Birgit Alteheld, Institute of Nutrional Sciences of the university of Bonn, Germany the following effect is explored: Effect of a 4 week therapy with AZT on synthesis of lipoproteins as well as Docosahexaen and other fatty acids in patients with Cystic Fibrosis (CF). Moreover proinflammatory cytokines in blood and sputum are of interest.

The macrolide azithromycin (AZT) is recommended by Flume in the CF pulmonary Guidelines for long-term treatment of patients with CF chronically colonized with Pseudomonas aeruginosa due to its immunomodulating properties . AZT causes a significant reduction of the proinflammatory cytokine Lipopolysaccharid binding protein (LBP) according to Steinkamp and Schmitt-Grohé. There is an inverse correlation between LBP and lung function. Moreover Schmitt-Grohé and coworkers provided evidence of a positive correlation between the lipoprotein HDL and lung function. Ribeiro and coworkers found an increased expression of Lipid/Cholesterol genes of primary human airway epithelial cultures after treatment with AZT. Freedman and coworkers were able to show decreased levels of Docosahexaen acid in CF patients.

The aim of this study is to explore the impact of a 4 week trial of AZT on lipoprotein and fatty acids (docosahexaen acid etc.) synthesis.

Delta F508 homozygous patients receive AZT (10 mg/kg body weight resp. max 500 mg) every Monday, Wednesday and Friday for 4 weeks. 20 patients (age 10-60 years) will be recruited. Fatty acids (blood), cytokines (whole blood and induced sputum) and clinical parameters are assessed before and 4 weeks after AZT treatment.

Eligibility Criteria:
Inclusion Criteria:

* Delta 508 homozygous and regularly visiting the CF outpatient clinic Bonn

Exclusion Criteria:

* clinical or laboratory signs (CRP \> 20 mg/L) of an exacerbation,
* treatment with systemic steroids 14 days preceeding this trial
* elevated liver function tests (\> twice normal range)
Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With CD19-TriCART Cell Therapy

This is a single arm, open-label, phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T, an autologous tri-functional anti- CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in Refractory/ Relapsed CD19 Positive Non-Hodgkin Lymphoma (NHL).

The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T to simultaneously targeting the CD19 positive NHL cells，blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
2. All subjects must be able to comply with all the scheduled procedures in the study;
3. Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma;
4. At least one measurable lesion per revised IWG Response Criteria;
5. Aged 18 to 69 years;
6. Expected survival ≥12 weeks;
7. Eastern cooperative oncology group (ECOG) performance status of ≤2;
8. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
9. All other treatment induced adverse events must have been resolved to

   ≤grade 1;
10. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB \>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

1. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment;
2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
3. Lactating women;
4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
5. Known history of infection with HIV;
6. Subjects need systematic usage of corticosteroid;
7. Subjects need systematic usage of immunosuppressive drug;
8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
9. Other reasons the investigator think the patient may not be suitable for the study.
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)

To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.

This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing EUS-LB
* Platelet Count \> 50,000
* International normalized ratio (INR) \< 1.5
* Age \> 18 years of age
* Non-Pregnant Patients

Exclusion Criteria:

* Age \< 18 Years of Age
* Pregnant Patients
* Inability to obtain consent
* Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
* Platelet count \< 50,000
* Presence of Ascites
* Known Liver Cirrhosis
SRAM Study_Postate Cancer

This is a phase 2 randomized study for High risk localized prostate cancer (T3 to T4 disease and/or PSA \> 20 and/or Gleason score ≥ 8) without evidence of distant and nodal metastasis.

Patient will be randomized to:Arm 1

* Conventional IMRT RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
* 38 fractions of daily treatment, Monday to Friday

or Arm 2

SBRT

* RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes)
* 5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy (detail as below)


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of prostate adenocarcinoma
* High risk prostate cancer patients (i.e. T3 to T4 disease and/or PSA \> 20 and/or Gleason score ≥ 8)
* ECOG performance score 0-1
* Age ≥ 18
* History/physical examination within 2 weeks prior to registration
* Able to sign informed-consent

Exclusion Criteria:

* Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy)
* Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* Patients who have received prior chemotherapy.
Clostridium Difficile Vaccine Efficacy Trial

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document.
* Willing and able to comply with study procedures.
* Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
* Ability to be contacted by telephone during study participation.
* Negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
* Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
* Prior episode of CDI..
* Receipt of blood products or immunoglobulins within 6 months before enrollment.
* Subjects who may be unable to respond to vaccination due to:

  * Metastatic malignancy; or
  * End-stage renal disease; or
  * Any serious medical disorder likely to be fatal within the next 12 months; or
  * Congenital or acquired immunodeficiency; or
  * Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
  * Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
* Known infection with human immunodeficiency virus (HIV).
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Prior small- or large-bowel resection.
* Any condition or treatment resulting in frequent diarrhea.
* Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
* Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Eligibility Criteria:
Inclusion Criteria:

* patients with a visually significant (BCVA\<20/50) idiopathic epiretinal membrane.
* ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.

Exclusion Criteria:

* concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration).
* secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.
The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

This research proposal is submitted to fulfill the requirement of the PHD degree of Community Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi Arabia.

Background: Cupping is an ancient treatment remedy that has been used for many centuries in many parts of the world. In the Middle East, Wet cupping "Hijama" is still a popular treatment because of its religious background. Despite of that, it still has little scientific evidence that proves its efficacy. Many hijama healers claim that they have observed dramatic improvement in Blood pressure control of hypertension patients. Not many studies support that. This study should help to prove or disprove this hypothesis.

Objectives:

* To determine the efficacy of wet cupping on blood pressure among high blood pressure patients.
* To assess the incidence of wet cupping side effects in the intervention group.

Methods: The study design is a randomised controlled trial. There will be an intervention group of high blood pressure patients who will perform hijama in addition to their usual management, and a control group of high blood pressure patients who will receive their usual anti-hypertension management only. There will be 8 weeks follow up period. After that, data entry, analysis and interpretation will take place.

Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients


Eligibility Criteria:
Inclusion Criteria:

* High BP at the time of the study (SBP 140 mmHg or more and/or DBP 90mmHg or more). For patients with DM, high BP is defined as SBP 130 mmHg or more and/or DBP 85mmHg or more.
* Age between 19 and 65 years old.
* Males and females

Exclusion Criteria:

* Grade III Hypertension (SBP 180 mmHg or more and/or DBP 110 BP or more).
* Patients with very high added risk,according to the Saudi Hypertension management guidelines. By excluding the patient who have associated clinical conditions which are: cerebrovascular disease, heart disease, renal disease, peripheral vascular disease and advanced retinopathy.
* Patients with secondary hypertension.
* Pregnant women.
* If the patient performed dry cupping, wet cupping or acupuncture during the past 6 months.
CMSL Ambulatory Sensitive Condition Nudge

The project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ED) use among adult patients seen at Geisinger's Community Medicine Service Line (CMSL) clinics. The intervention occurs immediately following an appointment where they received a diagnosis of an ambulatory sensitive condition (ASC). The evaluation will compare eligible patients with an ASC who were randomly assigned to receive follow-up outreach from a nurse (who was automatically prompted via the Epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. Analyses will be intent-to-treat. The primary outcome is ED use in the week following the appointment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years +
* Has a visit in CMSL with an ambulatory sensitive condition (ASC) encounter diagnosis
Lung Functions in Menopausal Obese Women After COVID 19 Recovery

The COVID-19 pandemic has presented considerable challenges to global health services and dictates almost every aspect of medical practice and policy. The menopausal transition may have significant consequences for respiratory health as COVID 19 symptoms subsides, lung function testing should be done to assess the consequences of this virus on lung health especially in menopausal woman.

The study group will consist of (40) obese menopausal women whom were recently recovered from mild-moderate COVID 19 for one month. The control group will consist of (40) obese menopausal women; whom will not affected by COVID 19. Using incentive spirometer, we will measure forced vital capacity FVC, forced expiratory volume FEV, Tiffano index TI and peak expiratory force PEF in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants recovered from mild to moderated signs and symptoms of COVID- 19 after one month.
* Ability to perform pulmonary function tests correctly.
* COVID-19 was diagnosed by positive polymerase chain reaction (PCR) testing on nasopharyngeal swab, oxygen saturation was ranged between 92-96% during illness period.
* CT chest shows ground glass opacity.
* Their D-dimer was less than 0.5 μg/ml.
* Two successive negative PCR were before included in study.
* Participants were in home isolation during illness period.

Exclusion Criteria:

* Chronic respiratory disease.
* Chronic heart disease.
* Diabetes mellitus.
* Smoking.
* Centralized isolation.
* Severe COVID-19.
The Effect of tDCS on Schizophrenia With Negative Symptoms

The investigators conducted a randomized controlled trial to reveal the effect of tDCS on negative symptoms in patients with schizophrenia and its underlying mechanism using the neuroimaging and electrophysiology.

The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.

Using anodal and cathodal tDCS the investigators aimed to treat negative symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 44 patients (22 in each group). 44 patients will be included in Seoul National University Hospital

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Schizophrenia
* 1 or more items of Negative symptom score in PANSS \> 5

Exclusion Criteria:

* presences of neurological disorder or history
* IQ \< 70
* presence of severe personality disorders
* presence of substance use disorder (except nicotin)
* pregnancy
* presence of severe medical condition or disorders
Postpartum pElvic Assisted Recovery With Leva

The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device.

In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum.

Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous vaginal delivery within the last 4-8 weeks
* Age ≥ 18 years
* Ambulatory
* Willing and able to consent to participate.
* English speaking
* Owns a smartphone

Exclusion Criteria:

* Operative or cesarean delivery
* Obstetric delivery at less than 20 weeks gestation
* Third- or fourth-degree perineal laceration
* Episiotomy
* Multiples