cyrilzakka/clinical-trials huggingface dataset:
Adjusted Fibrinogen Replacement Strategy

The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. This non-inferiority study focused on the primary objective of demonstrating that BT524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.

Fibrinogen is the first coagulation factor to become critically reduced during intraoperative bleeding. Therefore, rapid supplementation of fibrinogen to restore physiological plasma levels is an important component in achieving and maintaining hemostasis in bleeding patients. In this study, subjects with major blood loss during elective spinal surgery or abdominal surgery were randomized to receive either intravenous transfusion of the fibrinogen concentrate BT524, or fibrinogen-containing fresh frozen plasma/cryoprecipitate as first hemostatic intervention to rapidly replenish fibrinogen and control bleeding.

Eligibility Criteria:
Inclusion Criteria:

At screening:

1. Written informed consent
2. Subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (PMP) surgery with expected major blood loss
3. Male or female, aged ≥ 18 years
4. No increased bleeding risk as assessed by standard coagulation tests and medical history

Intra-operative:

5.

1. Subjects who underwent spinal surgery: Intra-operative clinically relevant bleeding of approximately 1 L, requiring hemostatic treatment during surgery.
2. Subjects who underwent cytoreductive PMP surgery: Intra-operative prediction of clinically relevant bleeding of more than 2 L, requiring hemostatic treatment during surgery

Exclusion Criteria:

1. Pregnancy or unreliable contraceptive measures or breast feeding (women only)
2. Hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the Investigational Medicinal Products (IMP)
3. Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
4. Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of IMP
5. Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
6. Inability or lacking motivation to participate in the study
7. Medical condition, laboratory finding (e.g., clinically relevant biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation
8. Presence or history of venous/arterial thrombosis or TEE in the preceding 6 months
Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition

This research study is being conducted to find out whether changes in household and personal behavior aimed at reducing exposure to environmental chemicals in dust (increased house dust removal efforts/cleaning and hand washing) and consumer products (increased us of personal care and beauty products that are free of chemicals including phthalates, parabens, and phenols) results in lower exposure to environmental chemicals including polycyclic aromatic hydrocarbons (PAHs) and endocrine disrupting chemicals including phthalates, parabens and phenols. These chemicals may have harmful health effects, as they can interfere with normal functions of the body. This study will also assess changes in breast tissue composition to understand the role of environmental exposures in breast cancer risk.


Eligibility Criteria:
Inclusion Criteria:

* Participant of Columbia's Breast Cancer Research and the Environment (BCERP) Study that recruited from the Columbia Children's Center for Environmental Health (CCCEH) Mothers and Newborns cohort.
* Mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter).
* Mother was 18-35 years at time of daughter's delivery.
* Mother registered in the prenatal clinics by the 20th week of pregnancy.
* Mother free of diabetes, hypertension and reported HIV infection.
* Mother resided in northern Manhattan or the South Bronx neighborhoods of New York City for at least one year prior to pregnancy.
* Mother self-identified as African-American or Dominican.
* Only participants in the CCCEH birth cohort who answered in the affirmative to the question "I would like to be contacted about future studies" on the consent form of the Mothers and Newborns Study will be contacted to participate in this intervention.

Exclusion Criteria:

• None
RCT of Internet-Delivered CBT Treatments for Pathological Gambling: Comparing the Effects of Added Involvement From CSOs

Background: Problem gambling is a public health concern with prevalence rates at 2 %. Problem gambling also severely affects concerned significant others (CSOs). Several studies have investigated the effects of individual treatments based on cognitive behavior therapy (CBT), but there is a shortage in studies on the effect of involving CSOs in treatment. This study aims to compare an intervention based on behavioral couples therapy (BCT) involving a CSO with an individual CBT treatment to determine their relative efficacy. BCT has shown promising results in working with substance abuse, but this is the first time it is used as an intervention for problem gambling. Both interventions will be Internet-delivered and participants will receive e-mail and telephone support.

Method/Design: A sample of at least 100 couples will be randomized to either the BCT condition or the CBT condition. The participants will work through 10 modules over 12 weeks in a secure online environment, and receive support via email and over telephone. Repeated measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome measure is gambling behavior, defined as time spent and money lost on gambling, as measured by timeline follow-back. Secondary outcomes include gambling related harm, alcohol consumption, relationship satisfaction and mental health for the gambler as well as for the CSO.

Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT will be superior to CBT on increasing relationship satisfaction, d) relationship functioning will mediate change in gambling behavior in the BCT group and e) reduction in gambling behavior will mediate change in relationship functioning in the CBT group.


Eligibility Criteria:
Inclusion Criteria:

* The CSO is a parent, child, sibling, friend or partner of the gambler.
* Participants are at least 18 years old.
* The gambler is a problem gambler according to Problem Gambling Severity Index.
* Participants must have had a relationship with the gambler for at least 3 months.
* Participants must be able to read and answer questions in Swedish, and is willing to be in contact with a counselor each week.
* Participants must have access to internet.

Exclusion Criteria:

* Participants are currently in any other treatment related to problem gambling.
* The CSO is a problem gambler according to Problem Gambling Severity Index.
* Participants displaying symptoms of severe psychiatric disorders, such as psychotic- or bipolar disorders, judged to require further treatment.
A Qualitative Study of Delays in Hospital Admission in Patient With Acute Stroke

To identify the circumstance during decision making processes to seek medical help in patients with symptoms of acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed acute ischemic stroke by brain image and were able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* patients who had cerebral hemorrhage, aphasia, cognitive dysfunction or severe stroke with unstable vital sign.
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

The purpose of this study is to determine safety \& efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo \& to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder,
* Single Episode, or 296.3x Major Depressive Disorder,

Exclusion Criteria:

* Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
* Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
* Patients whose current episode of depression\>12 months or \<4 weeks from enrollment
The PAI Trial for Breast and Colon Cancer Survivors

The purpose of the study is to determine if a Physical Activity Index (PAI) tool that collects measures on physical activity, strength training and sedentary behavior can be used in a clinical setting to monitor patient behavior and provide specific recommendations on how to achieve and maintain behavior goals. The tool will be used after treatment is completed in breast and colon cancer survivors and will test if physician counseling combined with patient self-monitoring improves physical activity and reduces sedentary behavior over time.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 60 years or older diagnosed with breast cancer and women or men ages 60 years or older diagnosed with colon cancer within the last 5 years
* ≥ 3 months post-completion of last prescribed treatment (i.e., Chemotherapy, radiation therapy or surgery)
* Stages I-III (no stage 0 or metastatic cases will be included)
* Able to understand spoken and written instructions in English
* Participate in 60 minutes or more of MVPA (moderate to vigorous-intensity physical activity)/week for previous 6 months
* Have internet access or access to data sharing plan
* Willing to come to four Penn State Health visits over the course of a year, completing requested questionnaires
* Willing to use Garmin Vivofit device, participate in exercise coaching sessions and complete exercise logs between visits

Exclusion Criteria:

* Prior respiratory, joint or cardiovascular problems precluding PA
* Metastatic disease
* Planned elective surgery during intervention/follow-up
* Exhibit gross cognitive impairment

We will not include any of the following vulnerable populations: adults unable to consent, individuals who are not yet adults, pregnant women, neonates, or prisoners.
Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

The purpose of this study is to know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.

The investigators performed a clinical, randomized, double-blind trial in preterm infants \<1500g from March 1, 2010 to February 28, 2012. Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus acidophilus (boucardii strain) 1 X109 colonic forming unit (CFU)/ day for 4 weeks was added. Gastric tolerance, evolution, reason for discharge, and the development of Necrotizing enterocolitis was monitored. The diagnosis of Necrotizing enterocolitis was made by the treating physician according to Bell's criteria and was blinded to group assignments.The formulas were prepared by one of the investigators according to the group each patient was assigned. Using sterile technique, the probiotic with 1x109 (CFU) Lactobacillus acidophilus (boucardii strain) was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants. In case of control group only breast milk or formula for preterm infants was used.

All formulas were labeled for each patient and were delivered to the nurse in charge of infant feeding at 9:00 and 21:00 h.

Characteristics of Sample size and statistical analysis:

Sample size showed that the investigators needed 190 total preterm infants, based on the expected 50% decrease in the incidence of severe necrotizing enterocolitis in preterm neonates who received probiotics compared with control group with α 0.05 and β 0.20. Student´s t test or Mann Whitney U test were performed for mean differences regarding the general characteristics in the two study groups, Chi square or Fisher´s test for differences in proportions for mortality and complications between groups.

Eligibility Criteria:
Inclusion Criteria:

* We studied 150 preterm newborns \<1500gr who were recruited on the day that began enteral feeding according to the decision of the treating physician.

Exclusion Criteria:

* Preterm infants \> 1500g with Apgar score \<6 at 5 minutes, gastrointestinal malformations, fetopathies, patent ductus arteriosis with hemodynamic decompensation, asphyxia, and NEC suspected as classified by Bell were excluded from the study.
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with essential hypertension, untreated or currently taking antihypertensive therapy

Key exclusion Criteria:

* women of child bearing potential (WOCBP) if not on highly effective contraception
* Malignant or severe hypertension (grade 3 of WHO classification)
* History or evidence of a secondary form of hypertension
* Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
* Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency

This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom


Eligibility Criteria:
Inclusion Criteria:

* Patients with Growth Hormone Deficiency
* Patients treated with NutropinAq®
* Patients having completed growth (fused epiphyses)

Exclusion Criteria:

* Active neoplasia
* Pregnancy
Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke

The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.

Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.

The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with first stroke for more than 6 months
2. Discharge from all rehabilitation services
3. Ability to understand and follow commands
4. A carer able for helping the home program
5. No contraindication to assessment protocol and training

Exclusion Criteria:

1. Cognitive disorder with Abbreviated Mental Test less than 7
2. Unilateral neglect with Star cancellation Test less than 47
3. Sensory deficit
4. Unable to give informed consent
5. Unable to speak either Cantonese or English or Mandarin
6. Commodity that preclude them from undergoing training and assessment
7. Neurological disease other than stroke
Evaluation of OSSIX® Bone in Sinus Elevation

A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patient requiring vertical elevation of the maxillary sinus.
2. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of \> 4-5mm.
3. Males and females between 30-80 years old
4. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
5. Patients that are willing to sign an informed consent and participate in a clinical study
6. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
7. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.

Exclusion Criteria:

1. Patients who smoke over 5 cigarettes/day
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts
12. Patients with known collagen hypersensitivity.
13. Patients with sensitivity to porcine-derived materials.
14. History or malignant tumours of the maxillary sinus
15. History of local radiation therapy
Can Thought Field Therapy (TFT) be Helpful for Patients With an Anxiety Disorder?

The purpose of this study is to find out if Thought Field Therapy has effect on certain anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD).

Thought Field Therapy is an alternative treatment method that has been shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 52 patients, with one or more of the diagnoses agoraphobia, social phobia and/or PTSD, where randomized to either treatment with TFT or a wait list. The treatment group all got treatment in one week. 2 1/2 months later both the treatment group and the control group were tested on the same items as before the treatment started. After this evaluation phase the control group got the same treatment as the treatment or study group. Both groups were evaluated 3 and 12 months after treatment, the study group also 6 months after treatment. 4 patients were omitted because they changed groups. The study were performed from May 2002 until June 2003.

Eligibility Criteria:
Inclusion Criteria:

* One or more of the study diagnoses agoraphobia, social phobia and/or PTSD

Exclusion Criteria:

* Ongoing psychosis
* Ongoing serious drug problems
Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

The aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1), androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (PCR) method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.


Eligibility Criteria:
Inclusion Criteria:

* To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.
* To have isolated hypospadias for study group.

Exclusion Criteria:

* To have genitourinary surgery before.
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)

The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.

The purpose of this study is to determine whether treating certain patients with worsening heart failure as an outpatient with intravenous and oral medications can work just as well as treating patients in the hospital.

Participants who enter into the study and meet eligibility criteria will be randomly chosen to either get intravenous diuretic like Lasix in the clinic and get outpatient care, versus directly admitted to the hospital to receive intravenous diuretic and normal hospital care.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Presentation to a Duke outpatient clinic with heart failure requiring IV diuretics, as per clinician judgement
3. Able to provide signed informed consent
4. Successful completion of EuroQOL-5 dimensions survey

Exclusion Criteria:

1. Managing clinician without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
2. Patient without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
3. History of left ventricular assist device or heart transplantation
4. End-stage kidney disease requiring chronic dialysis therapy
5. New diagnosis of heart failure
6. Pregnant or breast-feeding
7. Fever \>101.0 degrees Fahrenheit at screening
8. Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol