cyrilzakka/clinical-trials huggingface dataset:
DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia.

OBJECTIVES:

* Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays.
* Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts.

OUTLINE: This is a multicenter study.

Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis.

PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of T-cell acute lymphoblastic leukemia
* Frozen lymphoblast samples available

  * NOTCH1-mutated or wild type sample available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

* Not applicable
Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.

This study will assess the predictive potential of circulating placental biomarkers for spontaneous miscarriage within the following month in an IVF setting. It is hypothesized that a robust algorithm including one or more of these biomarkers may allow for the accurate same-day distinction between women with a low and high risk of a spontaneous miscarriage.

Spontaneous miscarriage is the most common adverse outcome in the first trimester of pregnancy. This is a particularly stressful situation for the expecting parents, since their need for a final diagnosis is frustrated for a potentially extended period on time which may span over several weeks. The emotional impact of this complication can be devastating, resulting frequently in depression and anxiety which may last for several months.

In an attempt to allow for an earlier and more accurate diagnosis of first trimester miscarriage, multiple circulating placental biomarkers have been tested over last years. However, their potential usefulness in an everyday clinical setting remains unclear.

The investigators propose a single-center observational prospective cohort study in an in vitro fertilization (IVF) setting. All recruited consenting patients will collect blood samples on a day of the first pregnancy test (12-14 days after embryo transfer) and at the time of the first (at 5 weeks plus 4-5 days of gestational age) and second (at 7 weeks plus 4-5 days of gestational age) ultrasound scan to determine the circulating placental biomarkers concentrations in order to predict the pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) until the first obstetrical ultrasound, performed between 11 weeks and 13 weeks plus 6 days of gestational age.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 and \<49 years old
* Body Mass Index (BMI): ≥18.5 Kg/m2 and \<30 Kg/m2
* Pregnancy resulting from Assisted Reproductive Technologies (ART)
* Single blastocyst transfer pregnancy
* Pregnancy confirmed by blood test
* Gestational age \< 6 weeks at the first US
* Signed and dated informed consent

Exclusion Criteria:

* Spontaneous pregnancies
* Treatment for prevention of miscarriage (i.e. corticoids, aspirin, heparin)
* Those unable to provide the 11th-13th week ultrasound report
* Those unable to comprehend the investigational nature of the proposed study
The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis.

The investigators target the patients with perennial allergic rhinitis. After treatment in 2 groups (Cettum treatment and acupuncture treatment) the investigators will compare the effects of relieving symptoms and improving quality of life. So the investigators will confirm the efficacy of Cettum, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 19 to 60 years-old
2. Presence of nasal symptoms more than 2 consecutive years
3. Presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) with severity score ≥ 2 (0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom(s), and 3 = severe symptom(s))
4. Positive reaction to the one or more perennial allergen in skin prick test
5. Not having a problem with expression of opinion
6. Willingness to participate in this trial and to sign the informed consent agreement

Exclusion Criteria:

1. Treatment with nasal/oral corticosteroids within the past month; herbal medication for rhinitis within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
2. Presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening or opacification of the paranasal sinuses)
3. Presence of neoplasm, severe systemic inflammation, or other systemic disease that affects rhinitis
4. History of anaphylaxis for allergic tests
5. Females who is pregnant or lactating
6. Being difficult to maintain treatment (e.g. paralysis, severe physical or psychiatric disorder, dementia, drug intoxication, severe visual or hearing impairment)
7. Being afraid of moxibustion treatment or expected adverse effects
8. When the investigators determine that it is inappropriate for participation
Iron & Vitamin C Study

Iron overload is a life-threatening condition that can lead to liver disease, cardiac disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated free radicals. Both conditions of high and low iron stores may present with common signs and symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin, serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin.

The investigators are proposing a study to determine the effect of concurrent AA and iron supplementation on iron status of individuals with SCI. The investigators goal is to identify abnormal status that may be attributed to simultaneous supplementation of iron and AA to develop future supplementation protocols in this population for optimal iron status.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. 18 years to 90 years of age
3. Medically stable
4. Chronic SCI (\>6 months post injury) without regard to the level or completeness of lesion
5. Supplementation with:

   * A standard recommended dose of 120-200 mg oral elemental iron (tablet or liquid; ferrous sulfate, fumarate or gluconate forms) for a minimum of 6 months; or
   * A standard recommended dose of 250-2,000 mg AA per day for a minimum of 6 months; or
   * Both 120-200 mg oral elemental iron AND 250-2,000 mg AA per day for a minimum of 6 months.
6. Veteran

Exclusion Criteria:

Acute cardiovascular, pulmonary or renal conditions
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.

In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Histologically confirmed adenocarcinoma of the prostate
* Biochemical relapse after primary radiation therapy or surgery
* Normal testosterone levels
* 3 rising PSA after nadir, with interval between PSA determinations \> 2 weeks

Exclusion Criteria:

* Local recurrence by CT scan
* Distant metastases by bone scan
* Hypercalcemia
* Nephrolithiasis
* Renal insufficiency (serum creatinine \> 1.8 mg/dl)
* Pancreatitis
* History of ulcer or gastrointestinal bleeding
* More than 6 months of hormone ablation therapy
* Concurrent therapy for prostate cancer
* Uncontrolled HTN
* H/O MI, CVA, TIA
* Known coronary disease/cerebrovascular disease
* Platelet counts \<50
* Patients on anticoagulants
* Patients on lithium
Temporal Interference for Drug Resistant Epilepsy

This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.

Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

This study aims to investigate the treatment efficacy of TI deep brain stimulation by including drug-resistant patients aged 6-60. During and after TI stimulation, clinical and electrophysiology data will be recorded. Clinical, imaging and electrophysiology data will be analyzed and processed to advance the treatment of drug-resistant epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Participants are between the ages of 6 -60 years of age.
* Patients must be clinically evaluated as having drug resistant epilepsy.
* Persistence of disabling seizures at least 2 times per months or greater.
* Informed consent signed.

Exclusion Criteria:

* Psychogenic non-epileptic seizures within 12 months;
* Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
* Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; IQ \< 55 or severe cognitive dysfunction, unable to complete the study; Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
* Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; Pregnant, or planning to pregnant within 2 years; Participation in another clinical study within 3 months; Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in PD

This project was a Randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from DHQ hospital Toba Tek were randomly assigned, baseline assessment was done, Group A paarticipants were given baseline treatment along with mojzisova method, Group B participants were given baseline treatment along with stretching exercises, post intervention assessment was done, via WALIDD, Numeric pain rating scale (NPRS) and Pittsburgh sleep quality index (PSQI) questionnaire 45 minutes per session, 2 sessions per month for 3 months, data was analyzed by using SPSS version 26.

Primary dysmenorrhea is most common reported problems to gynecologists and physical therapists. There is long history of using over the counter painkillers. Due to this there is high absenteeism from schools colleges and work. On the basis of symptoms primary dysmnorhea can be separated from secondary dysmenorrhea.Physical activity has long been used for relieving the pain, menstrual symptoms and improve insomnia. Previous studies also reported the effects of stretching exercises, core stabilizing exercises yoga, Pilates, aerobics on improving the pain and symptoms in primary dysmenorrhea. According to researcher knowledge there is limited evidence on mojzisova method that how this method improve the menstrual symptoms, pain and insomnia in primary dysmenorrhea. The aim of this study is to see the effects of mojzisova method on pain, menstrual symptom and insomnia in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Pain must be recurrent (at least following three menstrual cycles).
* No history of any blood problems, such as thalassemia, folate insufficiency, or anemia due to a lack of iron. Five criteria to fulfill to be considered primary dysmenorrhea.
* Hypogastrium pain during menstruation.
* Irradiation of pain to lower back, lower limbs or lingual region.
* Inability to perform daily activity.
* The need for medical management or self-medication to control pain Nulliparous women with primary dysmenorrhea.

Exclusion Criteria:

* Female with history of any specific disease.
* Female with endocrine disorders.
* Had gone major surgery.
* Diagnosis of secondary dysmenorrhea.
* Having symptoms such as numbness and tingling sensation.
Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging

Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer.
* patients 25 to 80 years of age

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients who do not fall within the age range mentioned above
Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia

This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).


Eligibility Criteria:
Inclusion Criteria:

* Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.
* Estimated life expectancy ≥ 12 weeks
* Lansky (age \< 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50

Exclusion Criteria:

* Burkitt leukemia
* CD19-negative B-cell leukemia
* Active Central Nervous System (CNS) leukemia
* Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion
* Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped
* History of CRS grade 4 related to previous CAR T cell therapy
* Contraindication to Alemtuzumab administration
Association of Survival in Impact of Ultrafiltration Rates in Hemodialysis Patients

This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.


Eligibility Criteria:
Inclusion Criteria:

Patients with stable undergoing hemodialysis for \>1 year.

Exclusion Criteria:

Patients with combined therapy with peritoneal dialysis and HD. Patients without records of laboratory investigations during this period. Patients with transferred hospital and those lost to follow-up.
IGF-1 Therapy in Patients With Cystic Fibrosis

28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight and body composition in patients with cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis.
* Age \>= 18 yr.
* Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5

Exclusion criteria:

* Hemoglobin A1C \> 8.5 %
* Diabetic retinopathy
* Obstructive sleep apnea
* Respiratory failure requiring mechanical ventilation.
* Status post pulmonary transplantation.
* Concurrent or recent (within past 6 months) receipt of human growth hormone.
* History of adverse side effects to growth hormone other than carbohydrate intolerance.
* Pregnancy or attempting pregnancy.
* Women who are breast feeding.
* Sexually active women who refuse to use or are incapable of responsibly using reliable contraception.
* Proven non compliance with medical regimens.
* Inability or refusal to take subcutaneous injections.
* Known allergy to components in the IGF-I preparation.
Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches

This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. The cRCT compares the outcomes of patients randomized in clusters by site within four Federally Qualified Health Center (FQHC) networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus a health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals (experimental).

This RCT embeds novel effective interventions within large FQHC networks, namely, Community Healthcare Network and the Family Health Centers of New York University (NYU) Langone in NYC and Erie Family Health Centers and Friend Family Health Center in Chicago, serving patients with multiple chronic diseases or high comorbidity. This CER study compares two PCMH-based strategies and will provide a manualized training system that can be disseminated and implemented across the national FQHC networks, with over 9,000 delivery sites that serve nearly 25 million low-income and minority patients, and can be implemented in a wider range of practice settings, organization types and population characteristics.

Among 1920 adult patients with a Charlson Comorbidity Index ≥4 who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (8 FQHCs) and Chicago (8 FQHCs) this pragmatic cRCT aims to evaluate the effectiveness of two approaches to preventing destabilization that leads to unplanned hospitalization and increased disability.

This Patient-Centered Outcomes Research Institute (PCORI) study builds on the National Patient-Centered Clinical Research Network (PCORnet) Clinical Data Research Networks (CDRNs) in NYC and Chicago. Patients will be identified via electronic health records (EHRs) and their outcomes assessed through comprehensive, longitudinal, electronic health records that are aggregated by these PCORnet CDRNs.


Eligibility Criteria:
Inclusion Criteria:

* Established patients of the participating Federally Qualified Health Centers (FHQCs)
* Charlson comorbidity index ≥4

Exclusion Criteria:

* Metastatic cancer,
* End stage renal disease on dialysis
* Post-transplant
* Severe mental illness
* Drug/alcohol abuse
* Cannot communicate in English or Spanish.
Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth with Cerebral Palsy

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.

Youth with cerebral palsy (YwCP) do not have adequate exercise options that empower them to independently maintain their cardiometabolic health and, thus, live inactive, sedentary lifestyles that place them at substantially higher risk for cardiovascular disease, related conditions (e.g., hypercholesterolemia, diabetes, and hypertension), and mortality than the general population. No randomized controlled trial (RCT) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy.

VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs. The addition of behavioral coaching strategies such as goal-setting, confidence building, setting reasonable expectations, and understanding benefits, underpinned by theory such as the Social Cognitive Theory (Bandura, 2004), have been found to enhance the likelihood that people engage in and sustain a behavior.

Therefore, this study hypothesizes that 3-months of tele-monitored VR exergaming with behavioral coaching will result in strong adherence to moderate-intensity exercise and greater changes in key indicators of cardiometabolic health in YwCP, compared with a wait-list control group that maintains habitual activity (before receiving the intervention).

Eligibility Criteria:
Inclusion Criteria:

1. medical diagnosis of cerebral palsy
2. between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest
3. physician clearance to participate
4. access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
5. a caregiver to support the child

Exclusion Criteria:

1. physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
2. cannot use their arms for exercise or a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
3. complete blindness or deafness.
4. contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines