cyrilzakka/clinical-trials huggingface dataset:
Intrauterine Use of FloSeal: Is it Safe and Useful?

When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.

Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not.

Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal.

This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.

Patients will be followed until fully recovered from surgery, usually 6 to 8 weeks. Any complications will be duly noted and treated appropriately. The final end point for follow up will be when the patient is finally discharged from care having achieved what is usually perceived as a return to all normal activity.

Eligibility Criteria:
Inclusion Criteria:Women undergoing hysterectomy for non-malignant indications -

Exclusion Criteria:Malignancy Inability to remove uterus without morcellation

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Prospective Study on Asthma Control

Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups.

Achieving and maintaining optimal asthma control is a major goal of asthma management. Although the results of clinical trials advocate that asthma control can be reached in most patients, there is evidence that many subjects with asthma have poorly controlled disease and that there is a significant gap between the treatment goals and the current level of asthma control achieved in the general population.

The aim of this study is to assess the prevalence of uncontrolled and partly controlled asthma in Italy using a patient-based tool such as Asthma Control Test.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Male or female patients with asthma diagnosis (at least 6 months)
* ability to understand and fill in questionaires

Exclusion Criteria:

* Patients included in a clinical trial within the last 12 weeks
* Patients with serious illnesses
* Pregnant women
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe refractory UC patients
* Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
* Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction

Exclusion Criteria:

* Mild or fulminant type
* Renal failure patients, hepatic failure patients
* Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
* Patients who received LCAP or GCAP within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
* Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)

This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.

Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Pre-existing diagnosis of asthma
* Persistent, moderate or severe asthma as classified by NAEPP
* Sub-optimally controlled asthma
* Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids

Exclusion Criteria:

* Active cigarette smoking or ≥ 10 pack-years smoking history
* Xolair taken in the past 6 months prior to enrollment
* Oral prednisone taken in the last 4 weeks prior to enrollment
* Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis
* Subject is currently enrolled in another investigational drug study
Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Validated coagulation disorder

Exclusion Criteria:

* Not consenting to participate
* Multiple coagulopathies and comorbidities
Bimanual Training in Children With Hemiplegia

A randomized control trial of bimanual training in children with hemiplegia. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.

A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators developed HABIT in 2004 as an alternative to constraint-therapy that avoids use of a restraint. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The investigators have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Eligibility Criteria:
Inclusion Criteria:

\*willingness to agree to intervention and testing procedures and travel to the University for participation and testing

Exclusion Criteria:

* health problems not associated with CP
* uncontrollable seizures
* visual problems that would interfere with carrying out the intervention or testing
* botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study
Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests.
* Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.
Brain Metabolic Network of PET in Patients With Advanced Non-Small Cell Lung Cancer

This study is a retrospective study, screening patients with systemic PET / CT scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain PET images.Then make the brain metabolic network analysis and statistical analysis to explore the PET brain metabolic network of non-small cell lung cancer patients and the effect of chemotherapy drugs on brain metabolic network in patients with advanced lung cancer.

1. Enroll Participants
2. Collect PET/CT Images
3. Images Analysis
4. Statistical Analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced non-small cell lung cancer without any treatment and pathological confirmed non-small cell lung cancer.

Exclusion Criteria:

* Brain tumors (primary or metastasis), previous surgery, radiotherapy, chemotherapy, stroke, head trauma, psychiatric history (insomnia, depression, mania, schizophrenia and other psychiatric disorders), or history of drug dependence (e. g. sedatives, sleeping pills or sedatives)
First Report, Five Years Experience of the Acute Leukemia Work Group

The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.

Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Lymphoblastic Leukemia

Exclusion Criteria none
Feasibility Study of the Addition of a Personal Trainer to the Post-Treatment Regimen of Breast Cancer Survivors

The purpose is to examine the feasibility and preliminary effectiveness of the role of a personal trainer for non-metastatic breast cancer survivors to improve physical activity and well-being (in terms of quality of life).

After breast cancer treatment, many women are faced with effects of treatment such as changes in appearance, fatigue, and reduced quality of life as compared to the pre-disease state. An intervention to increase physical activity may be helpful to improve well-being and outcomes for women treated for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Post active breast cancer therapy (e.g. surgery and/or chemotherapy and/or radiation therapy), but may still be undergoing maintenance cancer therapy.
* Free of macro-metastatic disease
* Sedentary pre-cancer diagnosis: Those individuals not participating in a regular exercise program or not meeting the minimal physical activity recommendations from the General Surgeon which is accumulating 30 minutes or more of moderate physical activity on most days of the week
* Ability to provide informed consent
* Ability to provide a written physician's clearance
* Patients must be new to the Survivorship Clinic (within first 12 months).

Exclusion Criteria:

* Medical conditions that would preclude participation in a weight-training program.
* Those who plan on relocating outside the Greater Pittsburgh Area in the next 3 months of intervention.
Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.Investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.To our knowledge, there is no study regarding this subject to-date.Therefore, investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Infants who were born to mothers with suspected or evident COVID-19
* Accepted to participate with an informed consent of parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities
* Contraindication for breastfeeding
* Declined to participate
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise

The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.

Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* GOLD 2-4
* BODE-index ≥ 2
* Referred by physician to a CPET

Exclusion Criteria:

* Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
* Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
* Percutaneous coronary intervention (PCI)
* Hypertension that is not controlled
Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living with Sickle- Cell Disease in France

Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs.

The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.

This is a retrospective study. Patients or parents of minor patients living in France and suffering from SCD will be informed about the study and enrolled during their usual follow-up, or by patients' associations. They will be asked to answer an anonymous survey online relating to their whole life-course with SCD and exploring different aspects of the consequences of the disease on their life. It contains 4 different sections:

1. socio-demographic questions to establish a respondent profile
2. health status of the respondent to establish the severity of the disease
3. education, professional life, material and economic situation
4. quality of life through MOS SF-36 questionnaire This is a one-shot survey, which will take approximatively 20 to 30 minutes to answer by the respondent.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with SCD or parent of a minor child diagnosed with SCD
* Able to speak and understand French
* Willing to participate to the study

Exclusion Criteria:

* Person having serious difficulties to read or speak French, unable to answer the questions
* Person suffering from other chronic disease which could bias the representation they have about SCD
* Patient cured with a bone marrow transplant
* Patient with mental disorder preventing the patient to understand the study
Determination of Protein Requirement in Elderly Male Subjects 65-75 Yrs Old.

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current dietary reference intakes (DRI) requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by national health and nutrition examination survey (NHANES), the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of male elderly subjects between the ages of 65 - 75 years using the IAAO technique.


Eligibility Criteria:
* Inclusion Criteria:

  1. Healthy elderly males between the ages of 65 to 75 years
  2. Willingness to participate in the study
  3. Males without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  4. Males with hypertension if well controlled by medications

Exclusion Criteria:

1. Presence of disease known to affect protein and amino acids (AA) requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
3. Significant weight loss during the past month.
4. Individual on weight reducing diets.
5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine)