cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions

This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.

Exclusion Criteria:

* Patients who are pregnant.
* Patients with ongoing abdominal abscess.
* Patients with ongoing bacterial peritonitis.
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma

The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy
* Progressive disease requiring further treatment
* Bidimensionally measurable disease
* Acceptable hematologic status
* Prestudy WHO performance status of 0, 1, or 2
* Expected survival of \>/= 3 months
* Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment
* Female patients must not be pregnant or lactating
* Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs

Exclusion Criteria:

* Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)
* Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment
* Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment
* Previous exposure to IDEC-114 or any anti-CD80 antibody
* ABMT within 6 months prior to first scheduled treatment
* Abnormal liver function
* Abnormal renal function
* Presence of chronic lymphocytic leukemia (CLL)
* Presence of CNS lymphoma
* Presence of HIV infection or AIDS
* Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma
* Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
* Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment
* Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment
* Pleural invasion and/or effusion with positive cytology for lymphoma
* Peritoneal invasion and/or ascites with positive cytology for lymphoma
Effects of Exercise on Depression Symptoms, Physical Function, and Quality of Life in Community-Dwelling Elderly

The purpose of this study was to investigate the effects of 8-week exercise training on depression symptoms, physical functions, and quality of life in the community-dwelling elderly.


Eligibility Criteria:
Inclusion Criteria:

* elderly subjects living in the community aged 65 years or older, sedentary lifestyle

Exclusion Criteria:

* cancer, major neuromuscular disease, respiratory or cardiovascular disease which might affect exercise
* post myocardial infarction or major surgery in the previous year
* psychological disease
An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)

This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients \>/= 70 years.


Eligibility Criteria:
Inclusion Criteria:

* Study phase 1: Patients aged \>/= 18 years
* Study phase 2: Patients aged \>/= 70 years
* Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

Exclusion Criteria:

* Contraindications to Avastin according to Summary of Product Characteristics
Effect of Ertugliflozin on Cardiac Function in Diabetes

The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.

This study is a phase 3, randomized, double-blind, active-competitor, parallel-group study that is anticipated to enroll 120 patients. Patients taking metformin and/or DPP4 inhibitors as per local label for ≥12 weeks without a dose adjustment before enrollment will be eligible for screening. All patients will have a screening period comprised of an up to 2-week screening phase prior to randomization. In order to qualify for randomization, patients must demonstrate compliance based upon pill count (80%) and discretion of the investigators during the Run-in phase.

Glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) will be masked to patients after randomization. To prevent partial unblinding, urinary glucose excretion (UGE) results will be masked to patients. Urine glucose, albumin, calcium, and creatinine will be measured separately on-site visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2D taking oral antidiabetic medications (metformin and/or DPP4 inhibitors) except SGLT2 inhibitors for at least 12 weeks without a dose adjustment before enrollment.
* eGFR ≥ 45 mL/min/1.73 m2.
* Stage B HF identified on the basis of either structural or functional markers.

Exclusion Criteria:

* Type 1 diabetes mellitus
* At the time of screening age \<20 years
* HbA1c \<7% or HbA1c \>9.5% at Screening
* FPG \>15 mmol/L (270 mg/dL) measured by the laboratory at Screening (Visit 1), and confirmed (\>15 mmol/L \[\>270 mg/dL\]) by a repeat test before randomization
* Treated with insulin and/or GLP-1R agonist within 12 weeks preceding the Screening Visit.
* Women of childbearing potential with no effective contraceptive method
* History of gastric surgery including history of gastric banding within 3 years before the Screening Visit
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma prior to the Screening Visit
* Mean blood pressure after 3 separate measurements \>180 mmHg in systolic blood pressure (SBP) or \>95 mmHg in diastolic blood pressure (DBP)
* Patients with current or prior symptoms of HF.
* Patients with severe anemia, severe respiratory, hepatic, neurological, psychiatric disorders or active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult
* Aspartate aminotransferase and/or alanine aminotransferase: \>3 times the upper limit of the normal laboratory range (ULN)
* Total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome)
* Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
* Patient who has taken other investigational drugs or prohibited therapy for this study within 3 months
Prediction of Bleeding in Placenta Previa

To assess the ability of clinical and sonographic variables to predict the need of blood transfusion \> 4 units of packed RBCS in women undergoing cesarian section for placenta previa .

Womenwith placenta previa after 32 weeks will be assessed for participation if they are eligible an adequate data will be taken :

- Clinical factors : including maternal age, abortion history, cesarean section history, gestational age at delivery, whether the operation will be carried out as an emergency surgery, and whether bleeding has started before the operation, will evaluated. The number of abortion history will be counted only if a dilatation and curettage was performed. Preoperative hemoglobin and hematocrit values will be checked. The amount of PRBCs transfused during operation will be measured.

-Ultrasonographic factor: Adiagnosis of placenta previa was made when the placenta covered the internal orifice of the cervix after 32 weeks' gestation. We will check for the presence of a hypoechoic area between the myometrium and the placenta. The vascularity of the placenta will be classified as normal or hypervascular on color Doppler imaging. We will examine the location of placenta ( anterior . posterior. Anterior with lateral deviation. Posterior with lateral deviation) and presence ofintraplacental lacunae (an irregular area of low echogenicity larger than 1 cm × 1 cm in the placental parenchyma)

* Intraoperative factor:

Assess surgeon years of experience Management plan hemostatic sutures other conservative management hysterectomy (primary or secondary) Assessment of amount of blood taken in 24 h from operation

Eligibility Criteria:
Inclusion Criteria:

* women with placenta previa after 32 weeks
* women with placenta accreta after 32 weeks

Exclusion Criteria:

* abruption placenta
* unavilable or limited avilability of blood group
Exercise-Induced Bronchospasm in Cystic Fibrosis

Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has been associated with better patient outcomes and quality of life. Exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. This study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.

We anticipate that Visit 1 will take approximately three hours. This will include obtaining informed consent, completing baseline demographic and quality of life questionnaires, brief physical exam, measuring exhaled nitric oxide level, skin allergy testing, obtaining blood and sputum samples, and performing pulmonary function testing before and after bronchodilators.

Visit 2 will take approximately two and one-half hours. This will include performing Eucapnic Voluntary Hyperventilation, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.

Visit 3 will take approximately two and one-half hours. This will include performing Cardiopulmonary exercise testing followed by serial spirometry, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females with confirmed diagnosis of Cystic Fibrosis:

   * 2 positive sweat chloride tests (or)
   * genetic testing
2. Age 12 years and older
3. Baseline FEV1 ≥70% predicted
4. Clinically stable over past 28 days:

   * no change in chronic respiratory symptoms
   * no need for antibiotics other then chronic maintenance therapies
   * no need for oral steroids
   * no increased use of bronchodilators
5. Visit 1 FEV1 within 10% of baseline

Exclusion Criteria:

1. History of Allergic Bronchopulmonary Aspergillosis (ABPA)
2. Chronic airway colonization with Burkholderia cepacia (defined as 2 or more prior positive sputum or BAL cultures)
3. Pregnancy
4. Chronic oral corticosteroid use
5. Febrile illness within two weeks of Visit 1
6. Unable to provide consent (patients under age of 18 will require both parental consent AND patient assent)
7. Current cigarette smoking, cessation of smoking within 6 weeks of Visit 1, or more than 10 pack-years of prior smoking
Denver Health Asthma Management Program

This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. The two texting interventions include 1) texting only the individual with asthma and 2) texting the individual with asthma and an important person in that individual's life such as a parent or spouse. These two texting groups will be compared to a group receiving usual asthma care at Denver Health.

This is Phase 2 of a two-phase pilot project to build and study a texting program for patients at Denver Health who have persistent asthma. The overall goal of the program is to provide educational support for asthma care between clinic visits and to survey for evidence of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered. Based on results of focus groups/interviews, the investigators will conduct a three-arm trial among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to 19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a subject group receiving text messages about asthma care and 2) a group of subjects and their 'significant other', such as a parent, who will also receive the text messages. Overall, Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a significant other and therefore for this group a 'usual care' arm will be compared to an arm where only the patient receives the text messages, but not a significant other. Other features built into Phase 2 upon recommendation from the focus group/interview phase include a midpoint survey and tailoring the amount of texting a patient receives based on the level of asthma control elicited by administration of the validated tool, the Asthma Control Test (ACT).

Eligibility Criteria:
Inclusion Criteria:

* Subject and significant other as applicable must have phone or other device capable of receiving text messages
* Ages 13 to 19 with persistent asthma per Denver Health electronic health record and/or HEDIS (modified) criteria for asthma
* Ages 20 to 40 with HEDIS (modified) criteria for persistent asthma
* Hospital-based utilization for asthma (i.e. persistent asthma)
* Denver Health Primary Care Provider visits within last 3 years
* Ability to read English or Spanish.

Exclusion Criteria:

* complex and special health care needs pediatric patients
* pregnant/expectant mothers
* incarcerated individuals
* Non-English and non-Spanish speakers
* Chronic Obstructive Pulmonary Disease/COPD or other non-asthma pulmonary diagnoses (e.g. pulmonary function testing inconsistent with asthma and/or negative methacholine challenge testing/lack of reversibility with β-agonist, diagnostic errors despite inclusion in the Asthma Registry)
* Patients who by input of the primary care provider are less likely to participate in an interactive asthma text messaging trial (e.g. intellectual delay, mental health issues)
Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section

The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 40 years
* American Society of Anesthesiologist physical status I and II
* Pregnant female for lower segment caeserian section

Exclusion Criteria:

* Patients with Hypertension
* Patients with hypo- or hyperthyroidism
* Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
* An initial body temperature 38.00C or, 36.0oC assessed by thermometer
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary

This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.

The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Evidence of CUP based on histologic examination
* Negative search for the primary tumor site using recommended guidelines
* Disease classified as good prognosis according to the French classification criteria: \*performance status \>2 and \*normal serum LDH
* No prior chemotherapy
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man
* Patients who do not fit inclusion criteria.
Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) ICSI outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Couples undergoing ICSI as result of male factor or tubal factor or unexplained infertility
* Women with regular menstrual cycles of 25-35 days
* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
* Women with body mass index (BMI) less than 30 kg/m2
* Women with both ovaries and intact uterus

Exclusion Criteria:

* Women with polycystic ovaries syndrome
* Women with endometriosis
* Women with gynaecological/medical disorders
* Couples with any sexually transmitted disease
* Women who had received any hormone therapy for less than 60 days preceding the study
MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation

At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate heart function. We propose to do a retrospective chart review of patient data along with their MRI data to analyze ventricular function and cavity volumes pre-Tetralogy of Fallot repair, post-Tetralogy of Fallot repair (pre-valve repair/replacement) and post-valve repair/replacement in order to assess the efficacy and optimal timing of valve replacement.

Patients with Tetralogy of Fallot have various degrees and levels of right ventricular outflow tract obstruction. They undergo surgical removal of the obstructing structures, which includes the pulmonary valve. The repair of the outflow tract is done utilizing a transannular patch. This approach, which is considered the standard of care, results in free pulmonary insufficiency, which may become severe and lead to right heart overloading and subsequent dilatation and dysfunction. This chronic overloading results in progressive tricuspid insufficiency and a suspected decline in effective pulmonary blood flow, cardiac output and right ventricle functional capabilities. Many patients develop progressive exercise intolerance, arrhythmias and severe cardiomegaly leading to dilated cardiomyopathy. The progressive decline in patient clinical status results in recommendations of pulmonary valve replacement to interrupt further dysfunction of the ventricles. Clinical improvement is generally seen among the patients and cardiac function is measurably improved in many cases, however the timing of surgery remains undefined and its impact on function improvement and recovery post -valve replacement is under serious debate and continuous discussion.

Preliminary work suggests that Magnetic Resonance Imaging (MRI) determined right to left ventricular volume ratio's of greater than 2:1 with associated tricuspid regurgitation, right ventricular regurgitant volumes of greater than 50%, and right ventricular ejection fractions less than 45% are common among patients with severe right ventricular failure and dysfunction. These patients are in need of pulmonary valve replacement and have routinely been referred for surgical intervention.

Patients with Aortic Coarctation have a localized malformation characterized by deformity of the aortic media, causing narrowing, usually severe, of the lumen of the vessel. Surgical repair or removal of this malformation is the treatment of choice however; the use of MRI to better determine the extent of damage or malformation would allow the surgeon to plan an operative strategy prior to opening the chest.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston.

Exclusion Criteria:

* Those patients who do not meet the inclusion criteria