cyrilzakka/clinical-trials huggingface dataset:
Bioimpedence and Arterial Function Monitoring at Birth and in Infants

Babies may be born appropriately grown for gestational age (AGA, \>10th centile) or small for gestational age (SGA, \<10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \<32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants (including those with SGA+/-FGR) in the postnatal ward
* Term and Preterm infants (including those with SGA+/-FGR) admitted to the neonatal unit
* Written informed parental consent

Exclusion Criteria:

* Antenatal or postnatal diagnosis of complex/life-limiting congenital anomaly or genetic condition
* Infants with no realistic chance of survival
* Infants with fragile skin not permitting use of cuffs for research purposes
* Babies whose parents have a limited understanding of English will be excluded in the event that communication via NHS translation services is not possible due to clinical demands on these services
A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients

The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 45 years of age
* A diagnosis of type 1 diabetes

Exclusion Criteria:

* Women who are pregnant, lactating, or planning on pregnancy during the study
* History of cancer
* History of heart disease
* Recent infection
Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)

To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.

This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C of any genotype;
* Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
* Inclusion criteria listed on the approved label in each country;
* Willingness of the patient to participate and sign the Informed Consent Form.

Exclusion Criteria:

* Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.
Prediction of Functional Disability and Clinical Trial in Subjects With Stiff Shoulders

First, the purpose of the first year study will examine the joint capsule/muscular and shoulder physical activity hypotheses related to ROM deficits as well as functional disability in subjects with Stiff shoulders. Second, the purpose of the second and third year study will investigate the long-term effect of 12-week joint mobilization, 12-week joint mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft tissue mobilization/massage with appropriate shoulder physical activity guide on subjects with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be recruited. Second and third years: forty-five subjects with Stiff shoulders for one year follow-up. Methods: For the measurement outcomes; functional disability, rotation range of motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis, goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and accelerometers, respectively.


Eligibility Criteria:
Inclusion Criteria:

* \[1\] a limited ROM of flexion, abduction, and rotation (ROM \< 20% to the sound side); and \[2\] pain and stiffness in the shoulder region for at least 3 months.

Exclusion Criteria:

* surgery on the particular shoulder, \[2\] rheumatoid arthritis, \[3\] stroke with residual shoulder involvement, \[4\] fracture of the shoulder complex, \[5\] rotator cuff deficiency, and \[6\] resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients

The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.

Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage.

In addition to the donor selection and donor screening, several viral safety steps have been included into the production process.

In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* Primary a- or hypogammaglobulinemia, particularly patients with X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
* Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
* A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose)
* Age \> 18 years
* The patient/legally acceptable representative has signed the consent form

Exclusion Criteria:

* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
* Known allergic reactions to human plasma or plasma products
* Have an ongoing progressive terminal disease, including HIV infection
* Pregnancy or lactation
* Known insufficiency of coronary or cerebral circulation
* Have renal insufficiency (plasma creatinine \> 115µmol/L)
* Have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection.
* Have IgA deficiency, and anti-IgA antibodies have been detected
* Active systemic lupus erythematosus (SLE)
Identification of the Region of Vitamin D Responsiveness

Hypothesis: low vitamin D status is associated with increased insulin resistance and increased blood pressure.

Approach: Multiple regression analysis of information extracted from a large database accumulated by a Canadian health foundation, specifically evaluating statistical associations between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.

Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard statistical analyses carried out. An association between 25(OH)D and the endpoints of interest was first established. The residual values after adjusting HOMA-IR, serum insulin, QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest 25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are then computed for each data block and each outcome variable. The location (along the 25(OF)D continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18

Exclusion Criteria:

* Diabetes
* Elevated HOMA-IR (\>16)
Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze

Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.

For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 6 to 24 months

* Patients of both gender
* Patients presenting to emergency department with bilateral wheeze

Exclusion Criteria:

Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).

* Patients with history of congenital heart disease.
* Patients with history of intubation for longer than 1 week during the neonatal period.
* Patients having symptoms consistent with croup.
* Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.
Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)

Study come to investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

To investigate the Foresee PHP ability to asses treatment progression post treatment.

The Foresee PHP is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee PHP™ demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The Foresee PHP can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as new CNV or treated CNV
* Age \>50 years
* VA with habitual correction \<20/160 in the study eye
* Ability to understand instructions

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Patients diagnosed with geographic atrophy (GA)
* Participation in another study with the exclusion of AREDS study
Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Granulomatous lobular mastitis (GLM) is a rare, chronic benign inflammatory disease of the breast, of unknown etiology. Pathologically, GLM typically manifests as non-caseating granulomatous lesions with leukomonocytes, lymphocytes, neutrophils and multinucleated giant cells, located in the center of breast lobules. With a rapidly increasing morbidity in the last two decades, GLM tends to occur in child-bearing women with a prolonged and recurrent course. Intralesional injection and topical corticosteroids can effectively reduce the side effects, especially in patients suffering from concomitant skin lesions (e.g., fistula, skin erosions, ulcers).For patients with diffuse disease, recurrence, or ineffective conservative treatment, wide local excision can be applied.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were pathologically diagnosed as refractory granulomatous lobular mastitis.
* Lesions are extensively distributed to more than three quadrants or with abscesses, sinus, fistula and persistent wound infection (skin ulceration and pus).
* Patients voluntarily participate in studies with informed consent.

Exclusion Criteria:

* History of breast surgery.
* Patients who choose conservative treatment.
Comparing of Long Bout and Short Bouts of Similar Volume of Walking in Obese on Weight Loss During a Weight Loss Program

The purpose of this present study is to determine if a daily walking program of 50 continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and obese women receiving a low calorie diet for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) between 27-35 kg/ m².
* were sedentary (reported exercising \<20 min/d for the previous 6 month) and healthy
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting

Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-calculus biliary obstruction who need palliative treatment

Exclusion Criteria:

* Fever (\> 37.8 Celsius)
* Leukocytosis (WBC \> 10,000 /mm3)
* Not candidate for surgical cure of obstruction
Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path

The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients


Eligibility Criteria:
Inclusion Criteria:

* Adult patient consulting for acute shoulder dislocation

Exclusion Criteria:

* Patient refusing to participate in the study
Pilot Evaluation of the EVERYbody Project

A pilot randomized-controlled trial explored the feasibility, acceptability, and efficacy of an inclusive dissonance-based body image intervention called the EVERYbody Project. The professionally delivered EVERYbody Project was evaluated in a universal college student population compared to a waitlist control group through one-month follow-up.

An existing dissonance-based body image program (the Body Project; Stice, Shaw, Burton, \& Wade, 2006) was adapted to directly discuss diversity within cultural appearance ideals (including race, gender identity, sexuality, ability, and age) and the individual and collective impact of pursuing exclusive appearance norms.

The feasibility, acceptability, and efficacy of the EVERYbody Project was assessed in an initial randomized-controlled trial. College students within a university in the Pacific Northwest United States were invited to participate in programming (universal intervention target).

Professional delivery of the two-session EVERYbody Project was compared to a waitlist control condition. Intervention groups were facilitated by one "expert" (faculty or staff with body image expertise) and two college student co-facilitators. Mixed methods assessment included a comparison of changes in quantitative eating disorder risk factor outcomes across randomization conditions and among students with marginalized identities at pre-intervention, post-intervention, and one-month follow-up. Qualitative interviews assessed the impact of the program on participants with marginalized identities. Feasibility and acceptability of the program was assessed to evaluate the appropriateness of the EVERYbody Project within universal college student audiences.

Eligibility Criteria:
Inclusion Criteria:

* Current college student enrolled at institution where research was taking place

Exclusion Criteria:

* None
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) \>=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count \< 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS\<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of WG according to American College of Rheumatology (ACR) and Chapel Hill Consensus Conference (CHCC) definition
* BVAS \>= 4
* Total disease duration \>= 3 months treated with CYC or \>= 6 months with MTX
* Age 18 - 80
* WBC \>= 4,000/mm3, haemoglobin \>= 8g/dl, neutrophils \>= 2,500/mm3, platelets \>= 100,000/mm3
* ALT, bilirubin and alkaline phosphatase levels within 2x the upper limits of normal
* Documented to be non-pregnant by serum/urine pregnancy test
* Willing to participate in this study
* Provide signed informed consent
* Able and prepared to self-administer the study drug or have a close friend/relative able to do this

Exclusion Criteria:

* Participation in another clinical research study
* Pregnant or nursing mothers and women of childbearing age not using appropriate contraception
* Clear evidence of active disease due to bacteria/viral infection
* Patient has an unacceptable risk for participation in a study of immunosuppressive therapy
* History of substance abuse or psychotic disorders
* Previous treatment with Gusperimus