cyrilzakka/clinical-trials huggingface dataset:
Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers

RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer

PURPOSE: This randomized clinical trial is studying how well an educational intervention works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and their families or caregivers.

OBJECTIVES:

I. Test the effects of the Bilingual Breast Cancer Education Intervention (BBCEI) on outcomes of breast cancer survivors (BCS) and family caregivers at 1, 3, and 6 months post intervention.

II. Test the effect of influencing demographic and treatment variables on outcomes of the BBCEI at 1, 3, and 6 months post intervention.

III. Examine the perceived quality of the BBCEI.

OUTLINE: Patients and caregivers are randomized to 1 of 2 intervention arms.

ARM I: Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7.

ARM II: Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7.

All patients and caregivers receive reinforcement telephone calls every other week.

Eligibility Criteria:
Inclusion

* Histologically confirmed diagnosis of stage 0 (DCIS), I, II, or III breast cancer
* No evidence of recurrent, metastatic, or second primary cancer
* Completing primary treatment with surgery, radiation therapy (if indicated), and/or adjuvant chemotherapy (if indicated)
* Subjects may be on hormonal therapy after treatment for initial breast cancer
* Self-identification as Hispanic/Latino
* Able to read and understand English or Spanish to participate in the patient teaching
* Able and willing to participate in the study
* The Caregiver selection criteria is: self-identification as the primary caregiver; age 18 years or over; self-identification as Hispanic/Latino; Able to read and speak English or Spanish; Able and willing to participate in the study

Exclusion

* Patients will be excluded if they are actively receiving treatment with surgery, radiation therapy, or chemotherapy; patients may be receiving adjuvant hormonal therapy such as Tamoxifen during the course of the study since it is recommended for five years after primary and adjuvant therapy
* Patients who have recurrence, metastasis, or a second primary cancer will not be recruited for the study; if however, they develop recurrence, metastasis, or a second primary cancer during the time of the study participation, the subjects will remain in the study
* Patients will not be recruited directly from support groups because of potential bias inherent in sample attending support groups; however, some patients may be participating in support groups or other forms of counseling
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis

The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.

Hypotheses:

* changes in plasma cells correlate to changes in immunoglobulins and effector cell responses
* the reduction of inflammation due to SCIT has influence on the effector cell responses
* changes in paraclinical measurements can be related to clinical findings

The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured

* the development of immunoglobulin response
* plasma cells under updosing phase
* changes in basophil activity under updosing and maintenance treatment
* subtyping of allergic sensitization
* clinical outcome and quality of life
* changes in mast cells in the nasal mucosa
* changes in the cell biology of the basophils

Eligibility Criteria:
Inclusion Criteria:

* rhinoconjunctivitis due to grass pollen allergy
* positive skin prick test and nasal allergen challenge test to grass pollen extract

Exclusion Criteria:

* severe comorbidity, severe asthma, pregnancy
Research on Suicidal Ideation of University Students in Harbin City and Cognitive Behavior Therapy

The purposes of this research are:

* to understand the status of suicidal ideation, suicidal behavior, and depression in Harbin University students; and
* to analyse the infect factors of suicidal ideation and suicidal behavior.

With cognitive behavior interventions on students with suicidal ideation, suicidal behavior, and middle or high degree of depression, the researchers can provide a scientific and effective intervention to the students.

Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial.

Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Department of Psychiatry, University of Pennsylvania, Philadelphia 19104, USA. gregbrow@mail.med.upenn.edu JAMA. 2005 Aug 3;294(5):563-70.

By using suicidal ideation scale, to assess the status of suicidal ideation and suicidal attempt in 6000 university students in Harbin city. About 300 students with suicidal ideation and depression disorder randomized into two groups (control and intervention groups) accept the cognitive behavior intervention. We will assess the depression after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Suicidal ideation or the scores of Beck Depression Inventory ≧14

Exclusion Criteria:

* have no Suicidal ideation and the scores of Beck Depression Inventory \<14
Mitochondrial Function in Patients With Severe Liver Disease

The researchers will recruit patients with liver disease at Parkland Hospital. Patients will fast overnight, and the next morning will receive an oral mixture of \[U-13C3\]glycerol (25 mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100 milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120 min after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of \[5,6-13C2\]- and \[4,5-13C2\]glucose indicates preserved mitochondrial function. The researchers anticipate that patients with severe liver disease will show a decrease in mitochondrial function and will inform biosynthetic function of liver mitochondria.

After the first 6 successful exams (see power analysis, below), healthy volunteers (age-, gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.

The researchers will recruit patients with severe liver disease at Parkland Hospital where the procedure will be performed. Age-, gender- and race-matched healthy subjects will be recruited from general population, and the procedure will be performed at the procedure room of the AIRC. Patients at Parkland will be screened and selected by Dr. Jeffrey Browning and Dr. Rodney Infante. After ingestion of 25 mg/kg \[U-13C3\]glycerol plus 25 mg/kg unlabeled glycerol in water (total glycerol dose, 50 mg/kg), blood will be drawn at +60 and +120 min.

Healthy subjects will make two visits to the AIRC for screening and study procedures. The screening visit will take an hour and the study visit will take 3 hours. Volunteers will be made comfortable in the procedure room of the Research Center. All the study procedures at both Parkland and AIRC will be under the direction of the principal investigator, Dr. Jeffrey Browning.

Eligibility Criteria:
Inclusion Criteria:

* Severe liver disease defined as known liver disease plus at least one of the following: serum albumin less than 3.0 g/dL or INR more than 2.0.

Exclusion Criteria:

* Portal systemic encephalopathy
* Pregnancy or breastfeeding.
* Anemia (hematocrit \< 32%)
* Significant weight loss or use of diet pills within previous 6 months.
* Cannot give informed consent, understand the protocol, or tolerate any aspect of the protocol.
Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

The lack of proven waterpipe smoking cessation interventions makes it important to explore interventions proven effective for cigarette smoking cessation. The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo. The investigators propose to conduct a randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in two parallel groups each consisting of 76 habitual waterpipe smokers who are willing to quit. Potential participants will be approached in cafés, word-of-mouth and through media and will be invited to the American University of Beirut Medical Center to complete study procedures. Both study groups will receive the same behavioural intervention in combination with either Varenicline (Chantix), an FDA approved drug indicated for use as an aid to smoking cessation treatment, or placebo. Participants will complete study procedures in four visits. During visit-1 the informed consent process, baseline assessments and randomization will be completed and Varenicline (Chantix) or Placebo will be initiated together with the behavioural interventions. The behavioural intervention will be continued over the next 2 visits. An end of treatment visit 12 weeks after quit date will be dedicated to assessing sustained quit rate and other outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Daily waterpipe smokers from the community of Beirut,
* aged 18 years or older
* willing to quit

Exclusion Criteria:

* Cigarette and/or cigars smokers,
* active malignancy
* Pregnant women
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.

The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.

Eligibility Criteria:
Inclusion Criteria:

Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.

Exclusion Criteria:

All sick newborn infants who were admitted to the intensive care unit.
Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics

Chronic alcoholics suffer from weak skeletal and cardiac muscle. The investigators have discovered a beneficial effect of spironolactone-treatment in that regard. Therefore, a double blind placebo controlled study is conducted, to examine the effects of spironolactone on cardiac and skeletal muscle-function in chronic alcoholics.

Our department has done research into skeletal muscle function in patients with liver cirrhosis. Post-hoc analyses of one of these studies suggested that treatment with spironolactone had a positive effect on muscle strength and endurance. This effect was probably caused by an increase in concentration of Na, K-pumps (sodium-potassium pumps) enabling the muscle cell perform better.

To verify this finding we have designed a double-blinded, placebo-controlled, randomized clinical trial with skeletal muscle strength, -endurance, Na, K-pump content, cardiac systolic, and diastolic function as primary endpoints. Spironolactone is tested against placebo in 40 participants included among our admitted and out-clinic patients. Muscle function-tests, muscle biopsy and trans-thoracic echocardiography is performed before and after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Alcoholism, male gender

Exclusion Criteria:

* Spironolactone treatment
* Tense ascites
* Hepatic encephalopathy
* Dementia
* Cancer
* Severe psychiatric disease
* Untreated thyroid disease
* Maltreated diabetes
* Spironolactone contraindications
* Kidney failure
Agility LP Ankle Arthroplasty Outcomes

This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Can comprehend and sign the informed consent
* Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008

Exclusion Criteria:

* Patient has had following procedures on the study limb within two years of TAA
* Revision of TAA
* Ankle arthrodesis
* Amputation
* Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion.
* Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Expanded Access to Voxelotor for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

The intent of this open-label, multicenter expanded access program (EAP) is to provide early access to voxelotor prior to market authorization

The purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor.

This EAP may continue until such time that voxelotor is commercially available or the Sponsor discontinues the voxelotor EAP. Discontinuation may occur earlier if an individual participant or physician or Sponsor Medical Monitor decides to discontinue treatment.

Eligibility Criteria:
Inclusion Criteria

1. Documented diagnosis of sickle cell disease of any genotype confirmed by laboratory testing during screening
2. Ineligible or unable to participate in actively recruiting clinical studies of voxelotor
3. Hemoglobin (Hb) ≤ 10.5 g/dL during screening
4. No alternative treatment options in the judgment of the treating investigator
5. Participants, who if female and of child bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of voxelotor, and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of voxelotor
6. Patient has provided documented informed consent (the informed consent form \[ICF\] must be reviewed and signed by each participant),or for participants under 18 years of age, signed parental/legal guardian consent and participant assent.

Exclusion Criteria

1. Female who is breast feeding or pregnant
2. Hepatic dysfunction characterized by alanine aminotransferase (ALT) \>4 × ULN
3. Patients with clinically significant bacterial, fungal, parasitic, or viral infection which require therapy:

   * Patients with acute bacterial infection requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
   * Patients with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive
4. Renal dialysis
5. Non-SCD conditions or complications of SCD for which survival beyond 3 months is unlikely, in the opinion of the treating Investigator
6. Any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable)
7. Participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational agent (or medical device)
8. Medical, psychological, or behavioral conditions, which, in the opinion of the Investigator, may preclude safe participation, interfere with compliance or preclude informed consent

The Sponsor Medical Monitor makes the sole and final enrollment determination for any patient.
Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.

This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.

Eligibility Criteria:
Inclusion Criteria:

* age 20\~80 years old
* ASA score : 1-2
* Regular laparoscopic cholecystectomy

Exclusion Criteria:

* Renal function impairement (eGFR \< 60 ml/min/1.73m2) or ESRD
* BMI \< 18.5 kg/m2 or \>30 kg/m2
* History of other abdominal surgery
* Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
* Emergent surgery
* Convert to open cholecystectomy
Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers

Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined.

Hypoxia exposure applied to professional athletes has attracted attention and scientific debate due to its effects on improving physiological response through cardiovascular and hematological mechanisms. Presently, hypoxic training programs are developed to improve exercise performance in athletes, a useful training method for athletes that may improve their performance in future sea-level competitions. 12 males were divided into the hypoxic (H) and control (C) groups. Group H was living and sleeping in hypoxic rooms (method live high-train low) for 8-14h/d (FiO2≈14%). The implementation of the project was intended to: 1) assess the dynamics of changes in the concentration of pro-inflammatory indicators and hematopoiesis in athletes to variable training loads and hypoxia, 2) explain the usefulness of hypoxic exposure in adaptation to physical exercise, 3) observe the length of the hypoxic cycle necessary to maintain the effect of high-altitude training. In the blood serum the level of basic biochemical indicators of fatigue related to muscle damage, inflammation, and energy deficit, i.e. total creatine kinase (CK) activity, C-reactive protein (hsCRP) concentration, nitric oxide (NO). Moreover, basic hematological indicators: morphology, reticulocytes, lipid profile, and ferritin. Also, angiogenesis regulators: vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFR2 and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined using a body analyzer. Further investigations into hypoxia methods while considering individual capabilities are necessary for gaining deeper insights, into how hypoxia affects blood count and different blood variables among athletes.

Eligibility Criteria:
Inclusion Criteria:

* member of national wrestler's teams, and sports camp participant.

Exclusion Criteria:

* negative symptoms of hypoxia, and/or injury.
A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy

Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in those engaged in binge and loss of control eating. This study will explore the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings as powerful and modifiable predictors of binge and LOC eating in pregnancy.

Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to a range of adverse health outcomes in pregnancy, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater rates of deviation from recommended weight gain trajectories, especially in those engaged in binge and loss of control eating. Food cravings are powerful triggers of binge and loss of control eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors and greater weight gain in pregnancy as well. This study builds on preliminary evidence to suggest that acceptance-based approaches are effective in reducing the adverse impacts of cravings on behavior by exploring the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants as predictors of maladaptive eating behaviors and deviations from recommended gestational weight gain trajectories.

The efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants will be examined in a randomized controlled trial. Pregnant individuals in the second trimester (n = 130) who endorse current cravings will be randomly assigned to the intervention or an untreated control group. The intervention group will participate in a single-session, self-guided online workshop imparting skills grounded in Acceptance and Commitment Therapy, including acceptance, defusion, and present-moment awareness. Both groups will complete comprehensive assessments at baseline, one-month follow-up, and at full-term. The results of this initial efficacy trial will inform the integration of acceptance-based self-guided health coaching targeting food cravings into routine prenatal care to prevent adverse outcomes associated with disordered eating behaviors in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Current residence in the United States
* Fluency in English
* Currently pregnant in the second trimester
* Experience of any food cravings

Exclusion Criteria:

* None beyond not meeting inclusion criteria