cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD).

Secondary Objectives are to:

* Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD
* Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
* Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD


Eligibility Criteria:
Key Inclusion Criteria:

1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit
2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
3. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
4. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable

Key Exclusion Criteria:

1. Prior participation in an anti-Interleukin (IL)-33 class antibody (including but not limited to REGN3500) or anti-IL-4Rα class antibody (including but not limited to dupilumab) clinical study; past treatment with or current treatment with dupilumab or another anti-IL-4Rα treatment
2. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit
3. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply
Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy

it's a prospective study aiming to improve quality of life of patients with acute lymphoblastic leukemia suffering from oral mucositis, receiving courses of methotrexate chemotherapy , by measuring vitamin D in those patients before induction therapy and the change in its level during treatment, that associated with methotrexate-induced oral mucositis, taking in consideration serum level of methotrexate, so we may have assiotiation between vitamin D difficiency and oral mucositis . at the end we can have preventive interventions to protect against this harmful side effect.

Treatment outcome of acute lymphoblastic leukemia (ALL) is improved recently and the 5-year survival rates reached 90% in developed countries . So more research currently focuses on strategies to decrease toxic adverse effects of methotrexate (MTX). Oral mucositis occurs in about 20% of patients receiving methotrexate Identifying risk factors leading to this side effects would be valuable to develop preventive interventions and improve quality of life for these patients .

Previous studies revealed a relationship between vitamin D deficiency and chemotherapy-induced oral mucositis in cancer patients. This hormone is important in many physiological processes in the body as bone mineralization and immune regulations. The main sourses of Vitamin D is production in the skin through sunlight exposure, diet and Vitamin D supplements .

Previous literature showed that receptors for vitamin D expressed in the mucosa and so there is a relationship between vitamin D deficiency and increase inflammation and impairment of mucosa .

Patients with acute lymphoblastic leukemia maybe at risk of vitamin D deficiency because of impaired vitamin intake and sunlight exposure . In this study we examin the possible role of vitamin D in relation to methotrexate induced oral mucositis in cancer patients.

* peripheral blood samples from patients before starting chemotherapy course with methotrexate and 24 hr after starting the treatment for measurement level of vitamin D, samples centrifuged at the speed of 2000 - 3000 rpm for 20 min , then analyzed using ELISA.
* blood samples after treatment also used to determine serum level of methotrexate which may lead to toxic adverse effect as oral mucositis , samples centrifuged at speed of 2000 - 3000 rpm for 10 min and analyzed using Viva-E equipment.
* All serum samples were stored at -80 °C and analyzed collectively

Eligibility Criteria:
Inclusion Criteria:

* patients with acute lymphocytic leukemia in South Egypt Cancer Institute
* patients recieving methotrexate in protocol of treatment
* both sex included

Exclusion Criteria:

* patients with other types of tumors
* patients refuse to join the research
* patients with comorbid hepatic or renal impairment
Parkinson's Disease Genetics Database

The goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing Parkinson's disease (PD).

1. To ascertain, study and establish a repository of DNA samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of PD.
2. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.
3. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.
4. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria.
* Patients ≥18 years of age who are able to provide informed consent
* Patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative.

Exclusion Criteria:

* Patients without a diagnosis of Parkinson's Disease.
A Pooled Analysis of the Data From Two Studies of Ammonium Succinate for Menopausal Symptoms

This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.

Both studies were conducted previously and were randomized, double-blind and placebo-controlled. They followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. Both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected.

Naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. Many alternatives exist, generally acting via estrogen receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does not have phytoestrogenic ingredients.

Eligibility Criteria:
Inclusion Criteria:

* vasomotor and psychosomatic complaints
* ability to comply to study protocol
* signed informed consent

Exclusion Criteria:

* cancer (current or prior, based on medical history)
* conditions requiring planned hospitalization in the next 6 months;
* endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.);
* any surgeries within 1 year of the screening;
* hormone therapy within 6 months of the screening;
* psychiatric diseases;
* diabetes mellitus;
* taking other supplements or medications that may affect the climacteric syndrome
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer

This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.

PRIMARY OBJECTIVE:

I. To estimate the percentage of participants that achieve complete clinical response.

SECONDARY OBJECTIVES:

I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT).

II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W\&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS).

EXPLORATORY OBJECTIVES:

I. To characterize ctDNA clearance or non-clearance patterns during TNT. II. To correlate ctDNA levels with a participant's pathological features. III. To preliminary assess the prognostic performance of ctDNA levels in relation to participant's clinical outcome.

OUTLINE:

Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.

Eligibility Criteria:
Inclusion Criteria:

* Participant must provide written informed consent before any study-specific procedures or interventions are performed
* Participants aged \>= 18 years
* Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:

  * T3N0M0 - T4bN2M0

Exclusion Criteria:

* Has radiologic evidence of distant metastases at the time of screening/enrollment
* Has received prior treatment for their rectal adenocarcinoma
* Requires or has received blood transfusion within 1 month of study enrollment
Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy

Epiretinal membrane is common disease, affecting 5\~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
* Age more than 20 years and less than 90 years old

Exclusion Criteria:

* secondary epiretinal membrane due to retinal surgery,
* impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
* glaucoma patients
* complication during vitrectomy (ex. Retinal tear, silicone oil injection, ...)
* other retinal disease except epiretinal membrane
* other ocular surgery history within 3 months
* intellectual problems or illiterate whom could not obtained informed consent
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of breast carcinoma with HER-2 overexpression
* At least one measurable brain metastasis
* Patients for whom, according to investigator assessment, whole brain radiotherapy is the best therapeutic option
* Performance status (WHO) \</=2
* Life expectancy \>/=3 months

Exclusion Criteria:

* Presence of neoplastic meningitis
* Any prior radiotherapy to the brain
* Patients for whom, according to investigator assessment, stereotactic radiotherapy is the best therapeutic option
* Previous neoplasms, other than breast carcinoma, within 5 years since enrolment
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD).

In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment.

The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, ≥18 years at screening
* Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥1800 mL/m at screening
* Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen
* Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial

Exclusion Criteria:

* Surgical intervention for PLD within 3 months before screening
* Treatment with a somatostatin analogue (SSA) within 3 months before screening
* Non-responsive to previous treatment of PLD with an SSA as per the Investigator's assessment
* Systematic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy
* Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the patient from safely participating in the trial
* Severe kidney disease, as defined by eGFR \<30 mL/min/1.73\^m2
* Severe liver disease defined as liver cirrhosis of Child-Pugh class C
* Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator
A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients with Solid Tumors

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable or metastatic solid tumors willing to provide signed informed consent.
* Histopathological diagnosis and metastatic status cancer at study entry.
* Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease.
* Life expectancy of more than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2.
* Adequate organ and hematological function.
* Measurable disease by RECIST v1.1 and iRECIST.

Exclusion Criteria:

* Patient has known untreated or symptomatic central nervous system metastasis.
* Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition.
* Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
* Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
* Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.
* Patient has received \> 3 lines of prior systemic chemotherapy for metastatic disease
Evaluation Montelukast in the Treatment of Status Asthmaticus

The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair) given with other standard asthma medications and treatments in the treatment of children with status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to standard intermittent treatments but requires a continuous medication to aid in breathing. While new medications have been used to better manage chronic asthma, acute asthma exacerbations continue to be a significant cause of hospitalization and even death in children. Oral montelukast is a very safe medication that is used to manage chronic asthma in children, but it has not been studied for use in status asthmaticus. If oral montelukast, given with other standard therapies, can reduce the treatment length associated with severe, acute asthma exacerbations in children, it could potentially improve both the morbidity and burden of pediatric asthma.

While new medications have been used to better manage chronic asthma, acute exacerbations continue to be a significant cause of pediatric morbidity and mortality. Montelukast holds an established role in the pediatric outpatient management of asthma and while two promising studies in adults have demonstrated its potential use as an adjunctive therapy for acute exacerbations, its similar use in pediatrics has yet to be established. This pilot study is designed as a prospective, double blinded, randomized, controlled, clinical trial comparing the use of oral montelukast plus standard of care vs. standard of care alone in children admitted for status asthmaticus to the pediatric intensive care unit (PICU). The primary outcome the investigators are interested in is the time to reach a Modified Pediatric Asthma Score (PAS) of \< 5, which, per the clinical protocol for the treatment of status asthmaticus, is the time when patients are able to come off continuous bronchodilator therapy. If oral montelukast, given with other standard therapies, can reduce the treatment, emotional, and financial burden (e.g., shortened intensive care stay) associated with severe, acute asthma exacerbations in children, it would provide a significant therapeutic advantage, potentially improving both the morbidity and burden of pediatric asthma.

Eligibility Criteria:
Inclusion criteria:

* Between ages 2-148 years
* Requiring PICU admission for status asthmaticus
* Able to take oral medication
* Pediatric asthma score \> 8 on admission

Exclusion criteria:

* Intubated patients or other patients unable to take medications by mouth secondary to anatomic or pre-existing craniofacial issues
* Patients already on montelukast as their controller medication
* Patients with a known allergy to montelukast
* Any patient with phenylketonuria (PKU)
* Any patient currently on treatment with rifampin, fluconazole, or Phenobarbital medications
Physical Activity and Neuropsychological Outcomes in a Cancer Population

Many cancer survivors experience treatment-related impairments in mental abilities such as memory, attention, and concentration (known as cognition). Research indicates that physical activity can improve cognition in healthy adults; however, little is known about whether physical activity can improve cognition among cancer survivors. This study will test whether a physical activity intervention results in improvements in cognition among breast cancer survivors, which may lead to interventions to improve cognition.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer survivors; diagnosed at stage 1, 2, or 3 less than 5 years ago -
* not scheduled for or currently undergoing chemotherapy; sedentary, defined as engaging in less than 60 minutes of moderate to vigorous physical activity each week
* accessible geographically and by telephone
* have access to the internet
* endorse experience difficulties with thinking abilities
* in addition, participants on adjuvant therapy (e.g., tamoxifen or aromatase inhibitors) must be able and willing to remain on that treatment for the 3-month intervention period to prevent confounding of biomarker concentrations by treatment.

Exclusion Criteria:

* history of coronary heart disease, diabetes, stroke, orthopedic conditions that limit mobility, or any other serious medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
* other primary or recurrent invasive cancer within the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
* unable to commit to a 3-month intervention schedule; any condition that, in the investigators' judgment, would contraindicate increased physical activity or otherwise interfere with participation in the trial
* unable to provide a blood sample at the baseline measurement visit
* unable to speak and read English.
LearningRx Cognitive Training for TBI

The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with Traumatic Brain Injury (TBI).

Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for TBI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ previously diagnosed with TBI
* Living in the greater Colorado Springs area

Exclusion Criteria:

* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging