cyrilzakka/clinical-trials huggingface dataset:
Pain Management Smartphone Application for Patients With Stage III-IV Head and Neck Cancer Undergoing Radiation Therapy

This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.

PRIMARY OBJECTIVES:

I. Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.

II. Train patients to use the pain management smartphone application (PMSA) and determine the compliance characteristics and the number of additional on-treatment visits (OTVs) prompted by usage of the application.

OUTLINE:

Selected patients are interviewed for input that will help guide the wording of questions of the PMSA. All patients/caregivers are then instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.

Eligibility Criteria:
Inclusion Criteria:

* Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer.
* Ability to understand and the willingness to use the PMSA on the patient's personal smartphone
* Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
* Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires
* English speaking

Exclusion Criteria:

* Radiation oncology patients undergoing palliative courses of radiation
* Patients who do not own smartphones
* Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
* Patients who are unable to eat and drink normally
* Patients who are unable to validate their understanding of the pain scale
Healthy Mothers on the Move

Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and 2006 in southwest Detroit.

Specific Aims

1. Intervention group participants will have improved levels of protective behaviors (improved daily dietary composition and increased level of physical activity) that reduce the risk of type 2 diabetes compared to control group.
2. Intervention group participants will have improved their status on clinical measures of risk for type 2 diabetes (anthropometric and metabolic status) compared to the control group.
3. To assess whether theory-based variables, including changes in attitudes, behavioral and control beliefs, perceived social support and behavioral intention change from baseline, and whether these changes influence behavioral outcomes.
4. To identify aspects of project planning and implementation that contributed to achievement of behavioral and clinical outcomes. Measures include recruitment, retention and intervention participation rates, barriers and facilitators of participation; and community involvement in, and satisfaction with, intervention components and project activities; and fidelity of intervention components.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* A resident of Southwest Detroit
* Less than 20 weeks gestational at the eligibility screening

Exclusion Criteria: women with:

* Type 1 or type 2 diabetes
* Incompetent cervix/cerclage
* Active thyroid
* Multiple gestation
* Cardiac, vascular or pulmonary disease
* Drug or alcohol addiction
* Serious physical or mental illness or condition that would substantially interfere with participation in or completion of the entire intervention
Autologous Testicular Tissue Transplantation

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs) in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia in adulthood and presence of a childwish, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs). In 2002, the University hospital in Brussels (UZB) was the first hospital worldwide to offer testicular tissue cryobanking for fertility preservation in boys and ado-lescents. Since then, several other centers in Europe and USA have implemented similar fertility preservation programs. However, up till now, autologous transplantations of cryopreserved testicular tissue have not been performed yet.

As soon as a patient returns to the Centre for Reproductive Medicine at UZB with the request to transplant the preserved testicular tissue, the investigators will first analyse semen and blood. If spermatozoa are found in their semen, men can immediately enroll in standard care for natural conception, intra-uterine insemination (IUI), in-vitro fertilization (IVF) or intra-cytoplasmic injection (ICSI). However, in case no spermatozoa are found in the ejaculate the investigators intend to propose and eventually perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Eligibility Criteria:
The eligible patients opted as a prepubertal boy to enroll in the fertility preservation program and on the moment of cancer diagnosis or hematological disorder, their parents have agreed to cryopreserve testicular tissue for later autologous transplantation.

Inclusion Criteria:

* At least 18 years old
* Desire to become a parent at the moment of intake
* Stable relationship with a female partner and minimal one year cohabiting
* Age of female partner \< 43 year
* Azoospermia on 2 semen analyses
* Normal standardised preliminary and preoperative bloodsampling results
* Complete remission of the oncological or hematological disease
* Approval of the treating oncologist or other specialist in case of non-oncological disease as reason for the testicular tissue preservation as a child
* Risk for presence of malignant cells in testicular tissue is negligible (according to multidisciplinary assessment)
* Presence of SSCs (positive MAGE staining) in one or two of the thawed fragments (If absence of SSCs in two of the thawed fragments, the case will be discussed multidisciplinary)
* Written informed consent for the transplantation of cryopreserved testicular tissue and follow-up after the procedure and of children born eventually after this procedure

Exclusion criteria:

* Risk for presence of malignant cells in the testicular tissue
* Contra-indication for surgery
* Contra-indication for pregnancy in the female partner
* BMI \> 32
* Heavy smoking (≥10 cigarettes/day)
* Instable psychological condition
Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC

A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm (total of 188 patients).


Eligibility Criteria:
Inclusion Criteria:

ICF signing;

* Age ≥ 18 years;
* Gastroesophageal reflux disease diagnosis;
* Grade 0 to grade III reflux esophagitis, assessed by means of upper gastrointestinal endoscopy;
* Ability to have the endoscopy, pH-metry and esophageal manometry examinations performed;
* Washout period of 1 week without using PPI, H2 antagonists and prokinetic agents and of at least 1 day without using antacids.

Exclusion Criteria:

* Presence of esophagitis requiring intervention (grade IV), esophageal varices, Barrett's esophagus, systemic sclerosis or ulcers (gastric or duodenal ulcers);
* Previous gastric or esophageal surgery;
* Dietary sodium restriction, metabolic alkalosis, hypokalemia, Barter syndrome; Pregnancy or breastfeeding;
* Concomitant diseases, such as kidney, liver and heart failure;
* Suspected or confirmed cancer of any type;
* Abusive drug or alcohol use;
* Abnormal values for white blood cells, platelets or hemoglobin;
* Significant changes in serum sodium, potassium, calcium or creatinine concentrations;
* Treatment with PPI, H2 antagonists or prokinetic agents that may not be withheld during the washout period of 1 week or during the study;
* Intolerance or allergy to any of the components in the drug products assessed in the study;
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs), antiemetic agents, macrolide antibiotics and systemic corticoids for a period equal to or greater than 2 weeks before the study or that is expected to require prolonged use during study treatment;
* Concomitant use or requirement of a gastric pH-dependent medication for optimal absorption;
* Scheduled use of other medications metabolized by cytochrome CYP during the study;
* History of active peptic ulcer;
* Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency;
* Recent participation (within the last 12 months) in another clinical study.
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Visual Analogue Scale (VAS) of pain is higher than 40 mm.
* Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

* Malignancy within the past 2 years.
* Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)

The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be a healthy woman between the ages of 18 and 45 years.
2. Women with diagnosed endometriosis or infertility (cases).
3. Women without a diagnosis of endometriosis or infertility (controls).
4. Subject must have regular menstrual cycles.
5. Subject must have a body mass index (BMI) between 18 and 40.
6. Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
7. Subject must be able to understand and provide consent to procedures and use/disclosure of protected health information.
8. No history of Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, hepatitis B, and HIV.
9. For IVF study subjects, a minimum endometrial thickness of 7mm at the time of sample collection.

Exclusion Criteria:

1. Pregnant women.
2. Study subjects with endometrial cancer.
3. Study subjects with a history of endometrial ablation.
4. Study subjects with undiagnosed uterine bleeding.
5. Women with reproductive diseases that affect the endometrium (such as fibroids or uterine polyps that distort endometrial cavity).
6. Study subjects with an intrauterine device (IUD).
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms
4. Other protocol specific inclusion criteria may apply

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   * Schizoaffective disorder
   * MDD
   * Bipolar disorder
   * Delirium, dementia, amnestic or other cognitive disorder
   * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific exclusion criteria may apply
Weight Loss Via Bariatric Surgery and Lifestyle Modification

Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical inflammatory and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical, inflammatory, and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

Methods: We recruited 79 participants who were assigned to three groups: bariatric surgery (BS group n=27), lifestyle intervention (LS group, n=22), and waitlist control (C group n=30). For all participants, electrogastrography, inflammatory cytokines, gastric hormones analysis, body composition analysis, energy expenditure, and dietary assessment were done at baseline and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35 kg/m2,
* Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders

Exclusion Criteria:

* Taking weight-losing pharmacotherapy
* Who underwent previous bariatric surgery
Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain

The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year.
* Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent
* Have a history of moderate to severe CLBP

Exclusion Criteria:

* Have evidence of or a history of alcohol and/or drug abuse
* Have pain secondary to a confirmed or suspected neoplasm
* Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study
* Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)
Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1

The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with biopsy-proven breast cancer, head \& neck cancer or diffuse large B-cell lymphoma.
* For determination of Ki-67, S-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. For tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. Thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients.
* Newly diagnosed breast cancer, head \& neck cancer, or diffuse large B-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination and who have not received any treatment for their cancer.
* Able to give informed consent.
* Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of \[18F\]ISO-1 and determined to be negative.

Exclusion Criteria:

* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. Lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large B-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria.
* Unable to tolerate 60-90 minutes of PET imaging.
PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.

The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of VTE.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:

  1. Objectively confirmed VTE (DVT, superficial vein thrombosis \[SVT\], PE or unusual site thrombosis) diagnosed during the current pregnancy;
  2. Objectively confirmed VTE diagnosed in a prior pregnancy;
  3. Objectively confirmed VTE diagnosed when not pregnant;
  4. Inherited or acquired thrombophilia requiring anticoagulation.
* Receiving any dose or type of LMWH during the antepartum period

Exclusion Criteria:

* Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events)
* Unable to provide or declined consent.
* Home or birthing centre planned delivery.
Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, ages over 19 years
* Patients with post traumatic acute pain within 48 hr(sprain/strain)
* Patient whose pain scale is over 50 mm(VAS score)

Exclusion Criteria:

* Patients with chronic pain
* Presence of a fracture or more than one injury
* Previous adverse reaction or known allergy to NSAIDs