cyrilzakka/clinical-trials huggingface dataset:
Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors

RATIONALE: Biological therapy uses different ways to stimulate the immune system and stop cancer cells from growing. Cytotoxic T cells combined with interleukin-2 may be an effective treatment for recurrent brain tumors.

PURPOSE: Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in treating adults with recurrent brain tumors.

OBJECTIVES: I. Evaluate the toxicity of allogeneic cytotoxic T lymphocytes (CTL) when repeatedly instilled directly into the brain to treat recurrent primary brain tumors. II. Evaluate the response produced by allogeneic CTL and interleukin-2. III. Correlate CTL surface phenotype and degree of patient/donor HLA mismatch to response and toxicity.

OUTLINE: Surgery plus Biological Response Modifier Therapy. Tumor resection; plus intracavitary cytotoxic T lymphocytes, CTL; intracavitary Interleukin-2 (Chiron), IL-2, NSC-373364. CTL are generated in vitro by mixing irradiated patient lymphocytes (cultured with IL-2 and Monoclonal Antibody OKT 3, MOAB OKT 3, NSC-618843) with allogeneic lymphocytes and culturing the mixture with IL-2.

PROJECTED ACCRUAL: 10 patients will be treated. If severe toxicity occurs in the first 5 patients, the study will close.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Kernohan Grade III/IV primary malignant brain tumor that has failed conventional surgical resection and radiotherapy Evidence of recurrent tumor on gadolinium-enhanced MRI following completion of radiotherapy (minimum 5,000 cGy for adults) required The following histologies are eligible: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Mixed anaplastic glioma Surgical resection of progressing brain tumor feasible No evidence of tumor extending across the midline from one hemisphere to the other No multifocal tumor or leptomeningeal spread

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2,000 Platelets greater than 100,000 Hct at least 28% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 1.5 mg/dl Cardiovascular: No major cardiovascular problems Pulmonary: No major pulmonary problems Other: Seronegative for HTLV/HIV, syphilis, and hepatitis B and C No concurrent systemic infection Ability to maintain proper nutrition (orally or intravenously) during the study period required No pregnant women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: More than 4 weeks since systemic chemotherapy (6 weeks since carmustine), with the WBC increasing on 2 consecutive determinations at least 3 days apart Endocrine therapy: Not specified Radiotherapy: At least 8 weeks since radiotherapy Surgery: See Disease Characteristics
ADPKD Patient Registry

The purpose of the ADPKD Registry is to create an online patient network that includes at least 5,000 people with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who contribute data on their health and other topics. The ADPKD Patient Registry aims to support important scientific discoveries and support patient needs in the following ways:

* Connect ADPKD patients with opportunities to join clinical studies.
* Collect data for the research community to better describe the ADPKD disease experience and improve patient care.
* Engage with patients by measuring quality of life outcomes.

The ADPKD Registry will be a patient-powered network of people with ADPKD. This data will inform new research to improve ADPKD patient outcomes, learn more about the patient journey and discover unmet medical needs. We collect data most relevant to your ADPKD diagnosis, its major symptoms and management, as well as key demographic data (no personally identifiable information is shared). A Registry keeps information in one place making it easier for researchers to utilize Registry information while still protecting the privacy of those who take part. The Registry will be hosted on a secure, online platform that patients can access using their home computers, tablets or phones.

The purpose of the ADPKD Registry is to allow PKD patients to:

* Connect with researchers and express interest in taking part in certain clinical studies for ADPKD, including studies of new medications and other treatments.
* Take confidential health-related surveys. These surveys are aimed at better understanding of the health of people with PKD across their lifespans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or suspected diagnosis with autosomal dominant polycystic kidney disease (ADPKD)

Exclusion Criteria:

* caretakers, family members or friends of individuals with ADPKD
Comparison of the Efficiency of Maxillary Canine Retraction Using Aligners Versus Conventional Brackets in Orthodontic Extraction Cases.

The aim of this study is to compare the effectiveness of Clear aligners and Conventional braces for upper canine retraction (space closure) regarding canine tipping , anchorage loss and treatment time.

Conventional fixed orthodontic treatment with metal brackets has been rejected by some adult patients because of esthetic and social concerns, but the demand for orthodontic treatment is currently increasing. To satisfy the demands and needs of these patients, the emphasis has shifted toward esthetic orthodontic appliance system. Less noticeable appliances such as ceramic, resin, and lingual brackets, or removable clear appliances such as the Essix and Invisalign (Align Technology, Santa Clara, Calif) provide esthetic orthodontic appliance alternatives.

Since the introduction of clear aligners to the public in 1999, it has become a popular treatment choice for clinicians because of the aesthetics and comfort of the removable clear aligners compared with traditional appliances. Several studies have shown significant limitations of this technique, especially in treating complex malocclusions, whereas other studies have reported successfully treated cases with this removable appliance. A systematic review conducted to determine the treatment effects of clear aligners showed that no strong conclusions could be made regarding the treatment effects of aligners . Therefore, clinical trials were still required to investigate the effectiveness of the Invisalign system.

When using the aligners to correct severe crowding, root positions must be carefully controlled during extraction space closure, and clear aligners must be properly grip all teeth to be moved, Tipping was a common problem in premolar extraction cases during the early years of aligners use. Several previous reports have also discussed the limited ability of thermoplastic appliances to control root-tipping movements and to establish root control comparable to that provided by fixed appliances. The investigators describe the extraction treatment of a patient with moderate to severe tooth crowding using mini screws and clear appliances, thus eliminating the need for conventional brackets.

Eligibility Criteria:
Inclusion Criteria:

* 1) Moderate to severe crowding orthodontic patients.( Irregularity index of \<5 mm)

  2) Good oral hygiene. (Patient with periodontally sound dentition).

  3) Patient in permanent dentition between the age range 16 - 40 years.

  4) .Patients requiring extraction of mandibular and maxillary first premolars;

  5) Patients having sound general health

Exclusion Criteria:

* 1) Systematic disease.

  2) Poor oral hygiene patients.

  3 ) Periodontally affected teeth.
Autophagy and Inflammasome in Obesity: Effect of Weight Loss and Potential Therapeutic Implications

The main aim of this project is to determine the implication of autophagy and inflammasome in the pathogenesis of obesity and related comorbidities, and to explore in depth the mechanisms associated with the activation of immune cells leading early stages of the atherosclerotic process and metabolic disease. The hypothesis of the present study is that weight loss mediated by Roux-en-Y gastric bypass (RYGB) improves the protein expression of markers of autophagy and inflammation within immune cells. Moreover, the investigators will explore the association of these mechanisms with the mitochondrial function and dynamics, Endoplasmic Reticulum (ER) stress an intracellular nutritional status of leukocytes (measured by fluorescence microscopy and western blot). Further, the potential relationship between changes in the mentioned intracellular pathways and systemic pathological mechanisms including oxidative stress, inflammation and glucose and lipid metabolism will be explored. Hence, serum carbonylated proteins, myeloperoxidase (MPO) levels, antioxidant enzymatic activities including SOD (Superoxide dismutase) and catalase, circulating cytokines, and glucose and lipid metabolism parameters will be evaluated in a cohort of obese subjects before and 12 months after RYGB intervention.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 30 kg/m\^2
* duration of obesity over 5 years

Exclusion Criteria:

* history of drug abuse
* pregnancy or lactation
* neoplastic disease
* severe renal/hepatic disease
* history of cardiovascular disease
* chronic inflammatory disease
* secondary cause for obesity (hypothyroidism, Cushing's syndrome)
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection

The purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.

1. recruiting volunteers of H7N9 infection: age \> 18; patients signed with the informed consent; APACHE II \> 20 score
2. patients infused with menstrual blood progenitor cells infusion dose: 1\~10×10\*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion
3. test items and standard spirits lifted; pulmonary function improved; lung image injury improved

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of H7N9 infection
* must be critical injured for lung tissues

Exclusion Criteria:

* cancer diseases
* pregnancy
* mental disorder
* allergic constitution
* severe inflammation
Promoting Health in People With Fibromyalgia

Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.

Fibromyalgia is among the most common diffuse pain syndromes, affecting about 1 of every 10 rheumatology patients. People with fibromyalgia experience widespread chronic pain and fatigue that negatively influences their activity participation (causes disability) and overall quality of life.

The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate adoption of a wellness lifestyle in people with fibromyalgia. Specifically, we will test the efficacy of a health promotion computer program (Balance Center) used in conjunction with a wearable sensor (SenseWearTM) for developing a wellness lifestyle and improving the quality of life of adults with fibromyalgia. Balance Center software is a health promotion computer program that helps consumers to: (1) establish goals in the areas of physical activity, nutrition, participation in meaningful, productive activities, sleep, stress-reducing activities, and emotional state; (2) monitor progress toward established goals; and, (3) assess the relationship between these areas in one's daily life. In addition, based on consumer input, it offers suggestions for developing a wellness lifestyle. SenseWearTM, provides objective data about activity level and stress level for consumers to use in combination with the self-assessment data provided by the Balance Center.

In this randomized controlled clinical trial, the Experimental (Balance Center + SenseWearTM) Intervention is compared to a Usual Care, control group. Seventy-two adults (36 = Experimental; 36 = Control) with fibromyalgia will be randomized and followed for 6 weeks, exclusive of Baseline and Posttesting. The hypotheses to be tested are: Participants randomized to the Experimental Condition will demonstrate significantly (a) more physical activity, (b) a healthier, wellness lifestyle, and (c) fewer symptoms of fibromyalgia. In addition, the relationship between the decrease in fibromyalgia-related impairment on daily life and physical activity and a wellness lifestyle will be stronger at Posttesting than at Baseline in the Experimental Group, compared to the Control Group. The anticipated outcome of the intervention is more effective self-management of lifestyle and symptoms so that one can "live well with fibromyalgia."

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* meet the American College of Rheumatology criteria for fibromyalgia
* diagnosed with fibromyalgia at least 1 year prior to admission to the study
* have sufficient vision to operate a computer
* be English speaking
* have a private telephone line

Exclusion Criteria:

* live beyond a 40 mile radius of Pittsburgh
A Single and Multiple-Dose Study of SB1578

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive).
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive).
* Medically healthy with clinically insignificant screening results.

Exclusion Criteria:

* History or presence of significant disease.
Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.

This prospective interventional study. designed to evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse .fifty participants with cystocele of lateral type offered laparoscopic paravaginal repair. the investigator used a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal . The study evaluated the following outcomes Operative time, intra-operative blood loss, hospital stay , post-operative urinary symptoms, post-operative pain, fever, haematuria, post-operative vaginal wall prolapse .

Eligibility Criteria:
Inclusion Criteria:

* female patient with cystocele of lateral type ( paravaginal defect )

Exclusion Criteria:

* previous retropubic surgery,
* uterine prolapse,
* stress urinary incontinence or
* morbid obesity
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface

The goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing.

The goal of this study is to characterize the edge of contact lenses and its interaction with ocular surface.

Eligibility Criteria:
Inclusion Criteria:

* self reported normal subjects

Exclusion Criteria:

* any ocular diseases/conditions
* will not wear contact lenses
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.

This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.

Primary Objective

• To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer.

Secondary Objective • To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer.

Exploratory Objective

• To explore associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Plan for fractionated (≥15 treatments) proton beam thoracic radiotherapy with curative intent for lung cancer
* Non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) histology is permitted.
* Concurrent chemotherapy is permitted but not required..
* Previous thoracic radiotherapy is allowed.
* Ability to complete study surveys in English or Spanish
* Age \>/= 18
* Concurrent enrollment on other trials is permitted
* Patients who already use wearable devices and/or smartphones that monitor physical activity are eligible for this trial, provided they agree to utilize the devices provided by the study team during the study period
* All patients must sign study-specific informed consent prior to study entry

Exclusion Criteria:

* Ongoing treatment for another cancer that is expected to affect the toxicity profile of thoracic radiotherapy
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars

The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women receiving cesarean delivery
* Ages between 21-35 years
* Gestation ages ≥ 37 weeks and \< 42 weeks
* Willing to comply with study dosing and completed the entire course of the study
* Willing to give and sign an informed consent form and a photographic release form

Exclusion Criteria:

* Fibroids
* Placenta previa
* Placenta abruption
* Multiple gestation
* Antepartum hemorrhage
* Preeclampsia/Eclampsia
* Hepatic or renal dysfunction
* Any systemic uncontrolled disease
* Inability to provide consent
A 28-day Clinical Study on Facial Skin Rejuvenation

This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

The main expectation it aims to answer are:

* After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product.
* After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product.
* After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment.
* After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.

Eligibility Criteria:
Inclusion Criteria:

* females aged 30-50
* no history of cosmetic allergies
* according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all \> 2
* non-sensitive skin
* acceptable for split-face use of products for 28 days
* no using history of antibiotic in the past three months
* written informed consent and portrait right consent were obtained from all participants before study entry

Exclusion Criteria:

* subjects with known allergies or sensitivities to the ingredients in any of the study products
* anyone who is pregnant, nursing an infant, or planning a pregnancy during the study
* any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment
* unhealed skin lesions
* participated in any other clinical trial within one month
* received facial skin treatments including but not limited to lasers, chemical peels, dermal fillers within one year
* taken/injected anti-allergy medication in the past one month
* other medical reasons that could affect the test results
* participants in other clinical trials at the same time
Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo

The purpose of this study is to prospectively analyze and compare conventional stress echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine the effect of contrast agents used during real-time myocardial contrast stress echocardiograms on serum troponin I levels.

To compare two different stress echocardiograms (conventional Stress echocardiograms or Real-time Myocardial Contrast Stress Echocardiograms) that are in routine clinical use. The information, including the digital images that are collected during the stress tests is used to determine if the usse of specialized imaging techniques and ultrasound contrast can better detect blockage in blood flow to the heart and predict how patients outcome may be affected by this detection of a blockage.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age \> 19 years
* Scheduled for a stress echocardiography
* Are conscious and coherent, and able to communicate effectively with trial personnel
* For troponin evaluation, only hospitalized patients who had a troponin level drawn in the morning of and prior to stress echocardiogram will be included.

Exclusion Criteria:

* Pregnant and breast feeding women are excluded from participation because of the possibility of a bias as CSE is routinely used in pregnant patients secondary to lack of human studies to determine the fetal risk of use of Definity.
* Age \< 19 years old
* Known or suspected hypersensitivity to ultrasound contrast agents or other drugs used for the study
* Possibility that potential subject may be pregnant
* Studies where RT-MCE was specifically requested by the ordering physician