cyrilzakka/clinical-trials huggingface dataset:
Project Early Intervention 2000

The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.

Advances in neonatal medicine has increased the survival of infants with low birth weight. Repeatedly it has been documented an increased prevalence of psychological and medical problems in this group of children. Frequent psychological problems are intellectual disturbances, language delays, behavior problems like ADHD and learning difficulties. Usual medical problems are subnormal growth, various illnesses and neuro-developmental problems.

The high prevalence of psychological and medical risks makes this group of children target for follow-up assessments and early intervention.

The main aim of the project is to investigate whether sensitizing the parents will reduce the incidence of developmental disturbances in a group of low birth weight infants compared to a control group.

The study is carried out as a cooperation between the Departments of child- and adolescent psychiatry and pediatrics of the University Hospital in Tromsoe in Northern - Norway. 140 premature infants with birth weight less than 2000 grams are randomly distributed to an intervention and control group. In addition 70 full term infants are selected to another control.

A slightly modified version of The Vermont Intervention Program for Low Birth Weight Infants is applied to the infants in the intervention group, where the parents receive one hour of instruction from a special trained neonatal nurse one hour per day the last week before discharge (infant = 37 weeks G.A.). In addition, the parents receive four home visits during the the three first months after discharge.

Psychological and medical assessments are undertaken at ages: 36 weeks G.A., 6 months, 1, 2 3 5 years corrected for prematurity

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 2000 gram

Exclusion Criteria:

* Congenital anomalies
* Non-Norwegian speaking mother
* Triplets
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.


Eligibility Criteria:
Inclusion Criteria:

* Completed the BIAsp-1237 trial
Assessing Quality of Life of Patients With Prostate Cancer

RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

OBJECTIVES:

* Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease).

Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer
* Stratum I:

  * Clinically localized primary prostate cancer

    * T1-T3, G1-G3, N0, M0
    * Plan to undergo a radical prostatectomy OR
  * Local or locally advanced primary prostate cancer

    * T1-T4, G1-G3, N0, M0
    * Plan to undergo radiotherapy with curative intent
* Stratum II:

  * Metastatic prostate cancer

    * T1-T4, G1-G3, N1, M0-M1 OR
    * T1-T4, G1-G3, N0-1, M1
    * Plan to receive hormonal treatment

      * No anti-androgen monotherapy
* No cerebral metastases

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Mentally fit to complete a questionnaire
* Literate in the language of the questionnaires
* No psychological, familial, sociological, or geographical condition that would preclude compliance
* No other concurrent malignancy except basal cell skin cancer
* No concurrent participation in other quality of life investigations that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* See Disease Characteristics
* No prior neoadjuvant hormonal treatment
* Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I

Radiotherapy:

* See Disease Characteristics
* No interstitial radiotherapy
* More than 2 years since prior radiotherapy (stratum II)

Surgery:

* See Disease Characteristics
* More than 2 years since prior prostatectomy (stratum II)

Other:

* No prior treatment for prostate carcinoma
Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study

The goal of this observational study is to determine the relationship of ROTEM point-of-care coagulation assay parameters with excessive bleeding and clinical outcomes in patients undergoing cardiac surgery at Toronto General Hospital. The main questions it aims to answer are: i) How well does viscoelastic testing (VET) predict the clinical outcome of excessive bleeding in cardiac surgery? ii) Which VET parameters have the greatest accuracy for identification of patients who will have excessive bleeding? iii) 3) What is the prognostic value of abnormal VET parameters with other clinical outcomes after cardiac surgery?


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Underwent a cardiac surgical procedure with cardiopulmonary bypass

Exclusion Criteria:

- Did not undergo viscoelastic testing during surgery
Transvaginal Diagnostic Study in Women With Pelvic Pain

We propose a phase I study of laparoscopic assisted, transvaginal peritoneoscopy by using flexible endoscopy in female patients with pelvic pain. It is designed as a hybrid procedure with laparoscopy using one port for adequate safety with the ultimate goal in the future that transvaginal NOTES can replace therapeutic pelviscopy for this indication. The standard number of port sites for diagnostic laparoscopy is 2-3. By reducing the number and size of laparoscopic port, patients should already experience benefits from this hybrid procedure.

Approximately 50% of patients with chronic pelvic pain will have a normal laparoscopy. The vast majority of women with endometriosis, chronic pelvic pain and absence of ovarian endometriomata determined by ultrasound will have revised ASRM Stage I or II (peritoneal) disease with preservation of the posterior cul-de-sac. This sparing of the posterior cul-de-sac may offer a preferable route of entry for endoscopic surgery compared to the current standard of care.

Despite all the advantages of laparoscopic surgery, it is not free of risks and pain, and creates scars, which themselves are associated with complications such as abdominal wall hernias and adhesions.

Within this scenario, a new surgical procedure has emerged, called natural orifice transluminal endoscopic surgery (NOTES). This technique uses existing orifices of the body for introducing optical systems and surgical instruments into the peritoneal cavity by avoiding penetration of the abdominal wall. The expectations are no postoperative pain, optimal cosmesis without any visable scars and shorter recovery similar to therapeutic endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 and older who have an indication and scheduled for laparoscopic peritoneoscopy.

Exclusion Criteria:

* Known pelvic adhesive disease or greater than stage II endometriosis or sonographic evidence of endometrioma.
* BMI over 30.
* Major comorbidities - including diabetes, myocardial infarction, congestive heart failure, stroke, history of cancer or currently undergoing chemotherapy, autoimmune disease requiring immunosuppressive or steroid therapy .
* Any primary bowel disease (IBD, sprue, obstruction, acute appendicitis, gastric bypass, etc.).
* Pregnancy.
* Any known PID, tuboovarian mass or abscess, or active sexually transmitted infection.
* Retroflexed uterus
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease

This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution.

The assessment of cognitive scales included Minimum Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale-cognition(ADAS-cog), Neuropsychiatric inventory(NPI), quality of Life of Life in Alzheimer's disease(Qol-ADL), activities of Daily living(ADL), Geriatric Depression scale(GDS).Biochemical test included cholesterol, triglycerides, and low density lipoprotein.

Eligibility Criteria:
Inclusion Criteria:

1. All patients were diagnosed with dementia caused by AD in 2011, the latest diagnostic criteria for Alzheimer's disease (NIA-AA), according to the patient's clinical and cranial imaging findings
2. Improved Hachinski ischemic scale score \<4
3. All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia
4. MMSE(High school≤24,Primary school≤20;illiteracy≤17)
5. CDR 1-2
6. The subjects and nurses signed informed consent, and the nursing staff were able to take responsibility for the supervision of the participants
7. The subjects were stable
8. Cooperate, willing to complete all parts of the research, and have the ability to complete the study alone or with the help of the nursing staff
9. To cooperate with the study, do not live alone, such as living alone should keep in touch with the nurse every day.

Exclusion Criteria:

1. Heart lung kidney disease, may interfere to evaluate the efficacy and safety of patients at risk or special disease,for example:Congestive heart failure et al.
2. According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia
3. Improved Hachinski ischemic scale score（MHIS）≥4
4. Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis
5. Neurological or other medical disorders that affect the function of the central nervous system,like Moderate anemia,Vitamin B12 or folic acid deficiency, et al. Not with the cognitive function examination (including blindness, deafness, severe language disorders).
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).

Accumulating clinical evidence suggests positive effects of whole grain on cardiometabolic risk. However, outcomes of controlled trials indicate that substantial interpersonal variation occurs in these studies with regard to glucose homeostasis, with some persons being unaffected and others experiencing glucose-lowering effects due to whole wheat bread consumption. Whole grain (whole wheat) contains bioactive phytochemicals in addition to its well-recognized fiber content, and these constituents have not received adequate study to inform dietary recommendations. The objective of this study is to investigate the glucose-lowering effects of whole wheat bread in persons with prediabetes using multi-omics platforms that can provide an understanding of the complex interactions among the gut microbiome, gut metabolome, host metabolome, and gut barrier function. The hypothesis is that gut microbial metabolism of whole wheat and its major bioactive components is a determining factor of human health benefits. This will be tested by conducting a randomized, controlled crossover trial in persons with pre-diabetes who follow a controlled diet containing whole wheat bread or white bread for 2-weeks. Outcomes are expected to significantly advance an understanding of personalized, gut microbiome-mediated approaches in individuals with pre-diabetes to help guide dietary recommendations of whole wheat intake. In addition, novel evidence that maps out the differential functions of diverse genus/species of microbiota to biotransform whole wheat nutrients into more bioactive metabolites are expected.

Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose between 100-125 mg/dL
* BMI of 30-35 kg/m2

Exclusion Criteria:

* History of liver disease, cardiovascular disease, overt diabetes, or cancer
* Prescribed medications for hyperglycemia or dyslipidemia
* Use of dietary supplements, prebiotics, or probiotics
* Usage of antibiotics or anti-fungals within 3 months prior to enrollment
* Smoker
* Alcohol consumption greater than 2 drinks per day
* Aerobic exercise greater than 5 hours per week
* Pregnancy or fertility treatments
* History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment
* History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage
* History of myocardial infarction or cerebrovascular accident within 6 months prior to participation
A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)

A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

Eligibility Criteria:
Inclusion Criteria:

* Adult Subjects with Hemophilia A

Exclusion Criteria:

* Subject previously treated with AAV vector gene therapy
Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom

The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
* Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
* Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
* Patient initiated first-line therapy at least six months before the date their chart abstraction initiated

Exclusion Criteria:

* Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
* Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
* Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
* Patient medical chart is missing, empty, or not retrievable

Other protocol defined inclusion/exclusion criteria could apply
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years of age
* have T2D (HbA1c ≥ 7.0)
* speak English
* a family member willing to take part in the study

Exclusion Criteria:

* have received formal DSME in the past three years
* have a condition that makes it unlikely for them to be able to follow the protocol
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.


Eligibility Criteria:
Inclusion Criteria:

Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:

SUI

1. Stress urinary incontinence symptoms
2. Urodynamic stress incontinence confirmed with urodynamic testing
3. Female patient ≥ 21 years of age
4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
5. Planned surgery for primary SUI
6. Patient able and willing to participate in follow-up
7. Patient or authorized representative has signed the approved Informed consent POP

1. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent

Exclusion Criteria

Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:

1. Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect) for SUI only
8. Severe vaginal atrophy
9. History of pelvic irradiation therapy
10. Contraindication to surgery
Longitudinal Cohort of Thrombosis and Hemostasis Diseases

This is a multicenter, prospective, longitudinal, observational cohort study to investigate thrombosis and hemostasis diseases in Chinese patients. This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records.The incidence and risk factors of thrombosis and hemostasis diseases, the treatment methods, prognosis and medical expenses of these patients in China will be analyzed. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Thrombosis and hemostasis diseases are a group of high-risk hematological diseases, characterized by bleeding or hypercoagulability caused by congenital or acquired abnormalities in hemostasis, coagulation, and fibrinolysis. Thrombosis and hemostasis diseases included various bleeding and thrombotic diseases such as primary immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, disseminated intravascular coagulation (DIC), thrombophilia, pregnancy with ITP, pregnancy with prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, and so on. Thrombosis and hemostasis diseases have a high incidence rate, may affect patients' quality of life and even are associated with the poor survival. However, current studies are mostly based on data from limited sample size cohorts, lacking comprehensive and large-scale prospective cohort studies.

This is a multicenter, prospective, longitudinal, observational cohort study investigating the incidence and risk factors of thrombosis and hemostasis diseases, and to analyze the treatment methods, prognosis and medical expenses of these patients in China.This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as thrombosis and hemostasis diseases.

Exclusion Criteria:

* Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
* Patients with alcohol and drug addictions or mental illness affect their ability to comply with study requirements.
* According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.
Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Age 50 years or greater

Exclusion Criteria:

* Previously diagnosed osteoporosis, or receiving treatment for osteoporosis