cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
* Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry

Exclusion Criteria:

* Previous participation in this trial defined as withdrawal after administration of trial product
* Patient has received an investigational medicinal product within 30 days prior to this trial
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Platelet count of less than 50,000 platelets/mcL (at the screening visit)
* ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
* Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
* Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
* HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
Outcomes of Local Perforator Flaps in Oncoplastic Surgery

This is a single center experience of using local perforator flaps in partial breast reconstruction for breast tumors while evaluating cosmetic outcomes, patient satisfaction and well-being using a validated self-administered questionnaire.

Background \& Objectives: Various oncoplastic techniques have emerged over the years to preserve breast cosmesis and symmetry without compromising the principles of tumor excision. One of the newer techniques for breast volume replacement to achieve symmetry and cosmesis is the use of fasciocutaneous pedicled chest wall perforator flaps or local perforator flaps (LPF). The objectives of this study are to document the details of the surgical procedure as well as patient-reported satisfaction and well-being following the already performed surgical procedure using a validated BREAST-Q tool among Pakistani women.

Materials \& Methods: This prospective cross-sectional study will be conducted by enrolling all the 25 female patients who have undergone LPF for breast tumors at The Aga Khan University Hospital, Karachi. Data related to the procedure will be collected on a pre-designed proforma. Cosmetic outcomes and patient satisfaction will be evaluated using 2 scales from BREAST-Q BCT domain version 2.0. The questionnaire will be self-administered by the patients during their routine follow-up in the clinic. Data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 23. Mean (SD) / median (IQR) will be computed for quantitative variables and frequency and percentages will be calculated for qualitative variables. 2 sample t-test will be applied. P-value ≤0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* All female patients suitable for breast conservation who underwent a pedicled fasciocutaneous perforator flap for immediate partial breast reconstruction at the breast surgery section

Exclusion Criteria:

* For evaluation of surgical techniques, since this was a review of cases already operated, no cases were excluded.
* For cosmetic outcomes and patient satisfaction, patients who lost to follow, expired or did not give consent to participate in the study were excluded.
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons

DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe \[8\], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Ruthford grade 2-5 patients
* For patients whose arteries in both lower extremities meet the enrollment criteria, both lower extremities can be included
* At least one outflow tract over 10 cm at the distal end of the knee is continuous with a healthy back of the foot or internal and external arteries of the plantar
* The guide wire clearly passed through the lesion and the follow-up treatment was performed. In the case of failed anterograde passage, reverse puncture to achieve the guide wire through the lesion can also be included in the group
* After the failure of the first intracavitary treatment, the blood vessel can be recanalized by the intracavitary treatment again, and it can still be included in the group
* Patients with aortic iliac artery disease can be included in the group after the aortic artery is opened
* Patients who are willing to participate in this study and sign informed consent
* For severely infected R6 patients, if the infection is effectively controlled, they can be considered for inclusion

Exclusion Criteria:

* Patients who refuse to participate in this observational study
* Femoral popliteal artery disease with acute and subacute thrombosis
* Patients with thromboangiitis
* Patients who have failed endovascular treatment and transferred to surgical treatment
* For patients who have received plaque exfoliation on the femoral artery
* Patients who are allergic to heparin, low molecular weight heparin and contrast agents
* Patients enrolled in other clinical studies in the past 3 months
* Pregnant women
* Patients who have a life span of less than 2 years due to serious diseases
Investigation of Awareness Levels of Women Living in Turkey About Kegel Exercises and Pelvic Floor Muscles

Pelvic floor disorders affect millions of women and their lives in our country and around the world. Along with many factors such as age, obesity, menopause, smoking, number of births and mode of delivery, there is an increase in the prevalence of pelvic floor disorders. Pelvic floor disorders (urinary/fecal incontinence, pelvic organ prolapse, chronic pelvic pain, sexual dysfunction) negatively affect women, their families, caregivers of individuals who cannot meet their own needs, and society in many ways. Treatment of pelvic floor disorders is very costly on a community basis. An effective process is carried out with the use of non-pharmacological traditional and complementary therapies instead of invasive or pharmacological treatment in the early period of the treatment of symptoms of pelvic floor disorders.

Pelvic floor muscle training has a positive effect on voiding functions by strengthening the urogenital sphincter muscle. One of the commonly used methods for pelvic floor muscle training is the so-called Kegel exercise.

Sexual life, with its personal and social aspects, is an inseparable part of human beings in general, it is one of the most important factors in human life and happiness, especially in family life. Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops personality, communication and love.

Kegel exercises; It is a method for strengthening the muscles that fix the bladder, intestines and genital organs in the pelvis and control their movements. These are tightening and relaxation exercises that strengthen the pelvic muscles. Like all voluntary muscles, the pelvic floor muscles are muscles that get stronger and develop as they work. Women of all ages need to have strong pelvic floor muscles.

Eligibility Criteria:
Inclusion Criteria:

* Living in Turkey
* Women aged 18 and over
* Having an active sex life

Exclusion Criteria:

* Having a disease affecting the pelvic floor muscles
* Having pelvic surgery in the last 6 months
* Being receiving sexual therapy
Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction

Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .

Patients of both groups will be subjected to:

1. Case history including personal data, medical, surgical history and family history.
2. A full examination of the cranial and maxillofacial skeleton and soft tissue .
3. Evaluation of Visual Functions
4. Ophthalmologic consultation and clearance
5. Radiographic examination: CT scan
6. All DICOM data will be imported to the surgical planning software.

Virtual planning:

1. A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
2. The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.
3. The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated .

   The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery.

   Intervention Group: -

   • The STL file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation

   - A transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant.

   Control Group: -

   • The STL file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps.

   Follow up:

   All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week .

   Only one postoperative CT scan will be done after 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with blow out fracture isolated and / or combined with other fracture.
* Age group: from 18 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention.
* Patients willing for the surgical procedure and follow-up, with an informed consent.

Exclusion Criteria :

* Medically compromised patients.
* Patients with history of previous orbital reconstruction surgery.
* Uncooperative patients.
* Patients with systemic contraindication to general anesthesia.
Home Use Sensor Study

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects, age ≥18 years
2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year and using insulin by subcutaneous injection or insulin pump.
3. Subject has signed an informed consent form and is willing to comply with protocol requirements

Exclusion Criteria:

1. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
2. A condition preventing or complicating the placement, operation or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition
3. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm HG or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from cardiologist documented.
4. History of hepatitis B, hepatitis C, or HIV
5. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)
6. A condition requiring or likely to require magnetic resonance imaging (MRI)
7. Known topical or local anesthetic allergy
8. Known allergy to glucocorticoids
9. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include, but are not limited to, psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
10. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
11. The presence of any other active implanted device\*
Diet and Exercise for Underserved Women

The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.

Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.

Eligibility Criteria:
Inclusion Criteria:

* 25-50 years of age
* live in Census tracts with 25% or more below poverty in Columbia, SC
* waist circumference \>88 cm

Exclusion Criteria:

* insulin-dependent
* pregnant
* moderate exercise contraindicated
* not in control of food choices \[institutional setting or restricted diet\]
* uncontrolled hypertension
* weight \>430 pounds
Oral Vitamin D Supplementation in Elderly Women

The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments


Eligibility Criteria:
Inclusion Criteria:

* Females
* 70-80 years
* Living in the community

Exclusion Criteria:

* Renal disease
* Diseases that contraindicate vitamin D supplementation
* Medications affecting bone
* Malignancy
Montreal Heart Attack Readjustment Trial (M-HART)

To examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.

BACKGROUND:

Despite evidence that social support and various aspects of negative affect may influence prognosis after a myocardial infarction, the impact of psychosocial supportive interventions had not been demonstrated. Further, little was known about the impact of psychosocial and/or interventions among women patients. Previous work by Nancy Frasure-Smith and colleagues suggested that a one-year post-myocardial infarction program of monthly telephone monitoring of psychological stress symptoms, coupled with home nursing visits for patients reporting high stress levels, had an impact on one-year cardiac mortality and long-term myocardial infarction recurrences among men. However, methodological difficulties prevented drawing firm conclusions. A trial which corrected for these difficulties was conducted involving 948 post-myocardial infarction patients. However, the project was too small to study enough patients to assess program impact separately for men and women. The trial was supported by Canadian sources. The NHLBI supplemented the study in order to expand the sample size from 948 patients to 1,376 patients to allow gender analysis.

DESIGN NARRATIVE:

Randomized, with a multi-hospital design. At the time of discharge from the hospital following a documented myocardial infarction, patients were randomized to treatment and control groups. The control group received usual care from their physicians. In addition to usual care, treatment patients were phoned monthly and responded to a standardized index of psychological symptoms of stress. Those with high stress levels received home nursing visits to reduce their stress. Patients in both groups took part in three interviews: in the hospital, at three months, and at one year post-discharge. Interviews assessed depression, anxiety, anger, self-perceived stress, social support, medication compliance, and cardiac risk factors. Salivary cortisol, a physiological indicator of stress, was assessed on the evening following each interview. Indicators of residual myocardial infarction, ischemia, and arrhythmias were obtained from hospital charts. Outcome data were obtained from hospital charts, death certificates, and Quebec Medicare data and were blindly classified by study cardiologists.

Eligibility Criteria:
Men and women myocardial infarction patients.
Altering the Availability of Healthier vs. Less Healthy Items in Vending Machines

Background: While there is some evidence that increasing the range of healthier foods and drinks and/or decreasing the range of less healthy options may increase healthier choices, more work is needed to establish the reproducibility of any effect. The current study aims to investigate the impact of altering the availability of healthier and less healthy foods and cold beverages in hospital vending machines.

Methods: An adapted multiple treatment reversal design will be used, in which all standard vending machines serving snack foods and/or cold beverages in one hospital in England change the number of slots containing (i) less healthy items and (ii) healthier items over eight 4-week periods. Changes will take place in a two-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting food group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2\&3 and 5\&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales data will be obtained via records of machine restocking.

Planned Analysis: The impact of the availability intervention will be assessed in separate linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal) purchased, per restocking interval, with random effects for vending machine.


Eligibility Criteria:
Inclusion Criteria:

* All vending machines at one UK hospital selling standard-fare (i.e. not healthier alternatives) cold beverages and snack foods

Exclusion Criteria:

* Healthier alternative vending machines; vending machines selling hot drinks or meals
TissueLink Versus SEAMGUARD After Distal Pancreatectomy

The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.

The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure.

Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery.

Eligibility Criteria:
Inclusion criteria:

1. Age equal or above 18 years
2. Accepted for elective distal pancreatectomy for any indication

Exclusion from randomization process:

* Thickness of pancreas on preoperative CT scan images \> 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study.

General study exclusion criteria:

1. Current immunosuppressive therapy
2. Chemotherapy within 2 weeks before operation
3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation
4. Radiotherapy before operation
5. Inability to follow the instructions given by the investigator
6. Lack of compliance
7. Persons unable or unwilling to give informed consent to participate in this study
8. Pregnant women
9. Prisoners
10. Institutionalized individuals
Juvenile Rheumatoid Arthritis

The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.


Eligibility Criteria:
* Male or female age 2-17 yrs inclusive \* Minimum weight 10 KG \* Diagnosis of Chronic Arthritis