cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent
* Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
* Must meet the following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have had \>= 2 lines of systemic therapy or \>= 1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HSCT); Relapsed or refractory follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
* Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort

Exclusion Criteria:

* Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma
* Any prior solid organ or allogeneic stem cell transplantation
* Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
* Uncontrolled active infections
* History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis \[DVT\])
* History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
* History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
* Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
* Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%

The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years of age or older.
* The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus.
* Clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
* The presence of interdigital tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.

Exclusion Criteria:

* Females who are pregnant, lactating or planning to become pregnant during the study period.
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
* Use of oral Terbinafine or Itraconazole within 2 months prior to baseline visit.
* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
* Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation.
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
* History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis.
* Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.
Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.

To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with a diagnosis of partial epilepsy.
* 18 years and older.

Exclusion Criteria:

* Having a treatable cause of seizure.
* Having a progressive neurological or systemic disorder
Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

* Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
* Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

• Abstract : In palliative care, lymphedema results from various associations of cancer, hypoalbuminemia, electrolytic disturbances or organ failure. The lymphatic circulation cannot be summarized by the Starling's equation and obstruction cannot explain everything. An interstitial hypothesis underlines the role of the lymphatic pump and edema volume can be a crucial point. The SDO, via the direct liquid removal, can restore the lymphatic pump function. This volumetric effect can explain the long time effect of the SDO and the large range of liquid amount reported in effective SDO. The superficial lymphatic system, in the superficial layer of derma, drains 80 % of lymph flow. In edema, the increased volume leads to the creation of subcutaneous interconnected lacunas. The subcutaneous site for drainage is justified.

After topic anesthesia, three subcutaneous channels are created on the ankle's medial face of the edematous limbs and liquids are absorbed by pads. An additional drainage can be done on the external face of the thigh with liquid collecting bags in bedridden patients.

The study includes clinical examination, total and segmental bioelectrical impedance measured at J0, J4 and on exit or at J7 at the latest and daily weight, umbilic abdominal perimeters and segmental circumferences and QOL evaluation before and after SDO. Bioelectrical impedance is collected from hand-foot, thigh root-foot and under patella calf - foot electrodes. Segmental circumferences are collected at thigh, calf and ankle points identified from bone relief distance.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* palliative care patients
* Karnofsky Scale \< 50%
* Uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia...)
* Effective Social security regimen affiliation
* Signed informed consent

Exclusion Criteria:

* Refusal to take part in the study
* Local anesthesic contraindication
* Infected skin lesions.
Menopausal HT for Women Living With HIV (HoT)

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life.

Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV.

This trial is being done to see if:

* There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV
* Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV
* Hormone therapy is safe and tolerable for women living with HIV


Eligibility Criteria:
* Living with HIV
* Assigned female sex at birth
* Between the ages of 40 and 60 years
* In the late menopausal transition (perimenopause) or early postmenopause
* Experiencing hot flashes and/or night sweats
* Willing and able to complete a daily diary
* Does not have medical condition that would contraindicate hormone therapy
* Not taking medications to treat hot flashes
* Not taking medications that cannot be combined with hormone therapy
* Receiving antiretrovirals (HIV medication) for more than 1 year
* Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy
* Willing and able to provide informed consent after discussion with the research staff
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures

A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high \[10\]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
* Hematocrit \>30 %
* Routine anticoagulation and erythropoietin regimen
* No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
* No ongoing infection
* Signed informed consent form

Exclusion Criteria:

* Inclusion criteria not met
* Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
* Unstable clinical condition (e.g. cardiac or vascular instability)
* Life expectancy less than 12 months
* Known coagulation problems
* Patients participating in another study interfering with the planned study
Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage

This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18-70 years of age, body weight ≥ 20 kg and ≤ 150 kg
* Dermatological diagnosis of AD, SCORAD \>=20
* A positive RAST (≥CAP1) result for at least one aeroallergen specific IgE and total IgE \>=100kU/l at screening (or within the previous 12 months)
* Eligible to receive systemic therapy for AD in accordance to local guidelines
* Signed informed consent from patient

Exclusion Criteria:

* Evidence of skin disease other than AD (e.g. psoriasis) at the inclusion time
* Treatment with systemic AD medications or any investigational drug within a 30-day washout period
* Concomitant treatment with substances interfering with the immune system
* Permanent severe diseases, especially those affecting the immune system, except asthma
* Pregnancy or breast feeding
* History of food or drug related severe anaphylactoid or anaphylactic reaction(s)
* History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
* History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
* Elevated serum IgE levels for reasons other than allergy and/or urticaria (e.g.: parasite infections, hyperimmunoglobulin E syndrome, Wiskott - Aldrich syndrome or clinical allergic bronchopulmonary aspergillosis)
* Evidence of severe renal dysfunction or significant hepatic disease
* Evidence for active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
* History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Clinically significant laboratory abnormalities (not associated with AD) at Visit 1
* Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to Omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
* Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
* Patients with serious psychiatric and/or psychological disturbances
* Patients with a history of drug or alcohol abuse
* Patients who are unable to complete a patient diary or complete questionnaires on paper
* Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers

The goal of this clinical trial is to answer the research question whether hs Troponin I and NT-proBNP have a role in detecting atrial fibrillation in patients with pacemakers.

Objectives of the study:

1. To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
2. To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
3. To build a model to predict the prognosis of atrial fibrillation based on the detected subclinical markers related to atrial fibrillation and classic cardiovascular risk factors.

Information about age, gender, BMI, medical history, tests to evaluate liver function, kidney function, dyslipidemia, results of echocardiography, ECG, and chest X-ray will be collected from medical records and clinical examination.

The hs troponin I and NT-proBNP tests will be performed before the patient has a pacemaker.

The two tests above will be paid by research team. Patients do not have to pay for these tests.

Atrial fibrillation will be determined through ECG, holter ECG and pacemaker data.

Time to follow up patients in the study: According to the patient's follow-up visits after pacemaker placement: 1 month, 3 months, 6 months, then every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient is an adult (≥ 18 years old or older)
* There is indication for permanent pacemaker placement and patient agreement to permanent pacemaker placement
* Patient agrees to participate in the study

Exclusion Criteria:

* Patients had a diagnosis of atrial fibrillation in their past history or atrial fibrillation is discovered at the time of participating in the study
* Severe patients, at risk of death
* Pregnant
* The patient is indicated for surgery
* Patients with eGFR ≤ 30 mL/min/1.73m2
* The patient has a serious infection
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* ICU patient with severe sepsis
* Treated with aminoglycosides

Exclusion Criteria:

* Renal replacement therapy
* Allergy to aminoglycosides
* Confirmed and/or suspected to have myasthenia
* ICU-acquired neuromuscular disorder
* Under guardianship
* Prisoners
* The patient has already participated in the present protocol
Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability.

The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins.

Montmorillonite (MONT) is a phyllosilicate layered mineral; chemically it is hydrated sodium calcium aluminium magnesium silicate hydroxide. Potassium, iron, and other cations are common substitutes and the exact ratio of cations varies with source.

Due to its unique physicochemical properties, such as swelling and cation exchange capability, as well its mechanical and thermal stability, MONT can be efficiently used as matrix for immobilization of proteins with high molecular weight (e.g. Albumin) and proteins with low molecular weight (e.g.Aflatoxines). Therefore, MONT is used for therapeutic purposes, in pharmaceutical formulations and in food preparations. In vitro assays made in our laboratory, showed that MONT absorbs, in stable manner, alimentary proteins: beta-lactoglobulins, alfa lactoalbumines and the ratio MONT-protein (w/w) 1:3, 1:5, 1:15, results in the protein capture of 50, 27, 0 % of proteins respectively.

The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake evaluated with the blood MONT- protein ratio. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins at different ratio (w/w) 1:3, 1:5, 1:15.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning

Exclusion Criteria:

* not defined
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment

RATIONALE

* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.

PURPOSE

* This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.

Primary Outcome Measures

* Objective Response Rates

Secondary Outcome Measures

* Survival Free of Brain Metastases progression
* Overall Survival
* Systemic Side effects

Objectives

Primary

* Compare objective response rates in both arms of treatment

Secondary

* Compare survival free of progression in both arms of treatment
* Compare Overall Survival in both arms of treatment
* Compare side effects

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance status (KPS) ≥ 50
* Life expectancy ≥ 12 weeks
* Histologically confirmed non lymphomatous solid tumors at primary site
* Brain metastases diagnosed with cranial MRI/CT.
* Extracranial metastases or primary tumor uncontrolled are allowed
* Hemoglobin ≥ 10 g/dl
* Absolute neutrophil count of \> 1500/mm3
* Platelet count of ≥ 100,000/mm3
* Blood urea nitrogen (BUN) ≤ 25 mg/dl,
* Serum creatinin ≤ 1.5 mg/dl
* Serum bilirubins ≤ 1.5 mg/dl,
* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit

Exclusion Criteria

* Pregnant or breast feeding woman
* History of allergic reaction to iodinated contrast media
* Inability to swallow
* Systemic chemotherapy in previous 3 weeks
* Oral chemotherapy in previous 2 weeks
* Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
* Meningeal carcinomatosis
10th Mountain Healthy Minds Program App Study

The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members.

Participants will be informed about the study during regularly scheduled activities. They will be informed that enrolling in the study is voluntary.

Participants will complete a 10-15 minute battery of questionnaires at baseline and post-test. In between these assessments, they will be asked to download and use the Healthy Minds Program app for 4 weeks. Post-test assessment will occur following the 4-week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military at the 10th Mountain Division

Exclusion Criteria:

* N/A