cyrilzakka/clinical-trials huggingface dataset:
Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)

Congenital Telangiectasia or Coat's disease is an uncommon disorder that involves the growth of blood vessels of the macula. These blood vessels msy extend beneth the retina to produce an area of sub-retinal neovascularization(growth of abnormal blood vessels under the retina which "leak" fluid, causing reduction in vision). Limited forms of treatment are available in managing the neovascularization and its consequences. Anecortave Acetate injection will be considered as an attempt to control the growth of the abnormal blood vessels.

After evaluation, the patient will receive an injection of anecortave acetate (15mg) juxtascleral with a special cannula in the study eye. the patient will be contacted via phone on the day following the injection. If problem arises patient has to come back to see the study doctor. if patient is stable, a 3 month follow-up visit will be st-up.if the patient does not show improvement, the patient may be offered either thermal laser or PDT. If patient is stable, on the month 6 visit ,the patient will again receive another injection of anecortave acetate. The succeding follow-up schedule will be followed for a total of 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of congenital Telangiectasia (Coat's Disease).
2. Patients must be 18 years of age or older to receive treatment.
3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
4. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document CNV (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment.
11. Patient is on anticoagulant therapy with the exception of aspirin.
12. Patient is pregnant or nursing.
A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone

The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases
* Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis
* Age at enrollment ≥18 years
* Life expectancy \>3 months
* Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site
* Surgical candidate, as determined by the treatment team
* Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity.
* Must agree to practice an effective contraceptive method (for those with reproductive potential)

Exclusion Criteria:

* Prior radiotherapy to the treatment site
* Prior surgery involving the treatment site
* Tumor volume or distribution precluding effective SBRT
* Expected skin dose at the operative site ≥9 Gy
* Imminently impending fracture requiring immediate stabilization surgery
* Involvement of proximal tibia
* Autoimmune connective tissue disorder
* Administration of radiosensitizing medication 3 days before, during, and 3 days after RT
* Active infection
* Absolute neutrophil count \<1.0
* Pregnancy
Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities

The purpose of this study is to identify whether exposure to ambient levels of air pollution during normal daily activities has a functional impact on patients with coronary heart disease

Exposure to air pollution has been shown in epidemiological studies to be closely linked to cardiovascular morbidity and mortality. The exact components of air pollution that underlie the cardiovascular effects are not yet known, but combustion-derived particulate matter is suspected to be the major cause. In controlled exposure studies, we have recently demonstrated that exposure to diesel exhaust causes increased myocardial ischaemia with exercise in patients with asymptomatic coronary artery disease. The mechanism behind this effect is not yet understood, but we have shown that diesel exhaust exposure causes an acute impairment of two important and highly relevant aspects of vascular tone: vasomotor tone and endogenous fibrinolysis. In this study we propose to investigate the effects of exposure to ambient levels of air pollution on patients with stable, symptomatic angina pectoris, during their daily lives.

Eligibility Criteria:
Inclusion Criteria:

* Documented coronary artery disease
* Symptoms of stable angina pectoris
* Positive BRUCE exercise stress test between 3 and 13 minutes

Exclusion Criteria:

* History of arrhythmia
* Severe 3 vessel coronary disease or left main stem stenosis that has not been revascularised
* Resting conduction abnormality
* Digoxin therapy
* Uncontrolled hypertension
* Renal or hepatic failure
* Unstable symptoms or acute coronary syndrome within 3 months
Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing \<1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* Preterm babies born less than 34 weeks of gestation
* very low birth weight babies (weighing \< 1500 g at birth)
* Babies \<72 hours of age

Exclusion Criteria:

* Babies \>72 hours of life
* Syndromic babies
* Babies with suspected metabolic disorders
The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis

The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.

A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output


Eligibility Criteria:
Inclusion Criteria:

* cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
* With a headache frequency of 4-14 per month for the last six months
* Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.

Exclusion Criteria:

* Patients with past family history of seizures
* Other chronic pain disorders
* Severe depression (Beck Depression Inventory of 30 or more)
* Other significant neurologic or psychiatric diagnosis including substance misuse
* Metal implants in the head
* Pregnant or breastfeeding ladies
* Prior experience with TMS
Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

Pilot study to investigate the effect of choline chloride in cystic fibrosis patients with liver steatosis by comparing their status before and after the intervention

Within this single arm pilot study patients with cystic fibrosis and liver steatosis receive choline chloride (2x0.5 gram three times a day) as a food supply for 88 days. D9-choline metabolism is measured before and after the intervention phase. Hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (VLDL) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* male
* Cystic fibrosis is verified
* pancreatic insufficiency
* Decline of plasma phosphatidylcholine and steatosis of the liver
* informed consent is given

Exclusion Criteria:

* cirrhosis of the liver
* Hyperreactivity to choline containing food
* allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections
* FEV1 \< 40%
* smoker
* chronic alcohol consume
* clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver
* Implants or other reasons which make magnetic resonance examinations impossible
Readmissions After Cardiac Surgical Procedures

The aim of this study is to analyze the reasons for unplanned readmissions after cardiac surgery at the University Hospital Basel. Predictive factors for readmissions and the development over the last 10 years will be analyzed.


Eligibility Criteria:
Inclusion Criteria for readmission group:

* Patients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)

Inclusion Criteria for control group:

* Patients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)

Exclusion Criteria:

* Patients with other initial hospitalization reasons for heart surgery without heart surgery (conservative treatments, cerclage removal, pacemaker surgery) are not included in the analysis.
* Planned readmissions to the University Hospital Basel within 30 days
Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community

Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of tumor-induced hypercalcemia (TIH) or malignant bone pain (MBP) could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of TIH or MBP could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

Eligibility Criteria:
Inclusion Criteria:

If hypercalcemic:

* Serum corrected Ca+++\>= 2.5 mmol/L and symptomatic hypercalcemia
* Asymptomatic hypercalcemia with corrected Ca+++\>= 3.0 mmol/L
* Moderate to severe intolerable pain (\>=6/10 on numerical rating scale \[NRS\]) despite optimal treatments with a strong opioid such as morphine, hydromorphone, fentanyl, oxycodone or methadone
* Radiotherapy bone pain related to metastatic bone disease

Exclusion Criteria:

* Not on a regular bisphosphonate regimen
Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities

Primary care physicians have an important role to play in the delivery of cancer prevention and detection services to patients. Face-to-face counseling of physicians, called academic detailing, involves a brief and focused intervention, modeled on the practices of pharmaceutical companies. This type of intervention may increase physicians' attention to preventive opportunities and increase their screening behaviors.

The specific aims of this proposal are:

1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician cervical cancer screening at 3- and 6-months post-randomization, compared to the rate observed in a service-as-usual control.
2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of cervical cancer screening guidelines to different physician subgroups.
3. To conduct a cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the cervical cancer intervention implemented in physicians' offices.

The long-term goal of this project therefore is to reduce cervical cancer risks among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.

Eligibility Criteria:
Inclusion Criteria:

* Charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed

Exclusion Criteria:

* Exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.
Evaluation of a Home-based Parenting Support Program: Parenting Young Children

Background: Parents with intellectual and developmental disabilities (IDDs) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. However, parents with IDDs are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. Parenting Young Children (PYC) is a home-based parenting programme developed for parents with IDDs. PYC has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. The purpose of the proposed study is to evaluate the PYC programme for improving parenting in parents with IDDs where there is risk of child neglect. The study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in PYC.

Methods: The quantitative evaluation will have a multi-centre, non-randomised, comparative study design. Eligible for participation are parents with IDDs who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. Thirty parents receiving PYC and thirty parents receiving treatment as usual (TAU) will be recruited from Swedish municipal social services. Outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. The primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. Interview methods will be used to explore the perspectives of parents and children in the PYC group.

Discussion: This study is motivated by the need for evidence-based support for parents with IDDs, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. Social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate PYC in a non-randomized comparative study.


Eligibility Criteria:
Inclusion Criteria:

* Parents with IDDs, including ID and other cognitive disabilities (e.g., ADHD and ASD). Parents must have children aged 0-9 years living at home and be assessed by the social services to be eligible for tailored parenting support.

Exclusion Criteria:

* Ongoing substance abuse, ongoing child abuse, and/or mental illness of such nature and degree that it may affect parent management training.
DHA Supplementation for Lactating Mothers

The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM) Nutritional Lipid) The DHA supplement is available over the counter.

The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.

We designed a prospective, randomized trial to test the hypotheses that DHA supplementation to human milk providers will increase DHA concentration in milk and infant blood levels; and that infants receiving milk from DHA-supplemented providers will be receiving a more appropriate enteral intake to better mimic intrauterine accretion. In addition, we hypothesize that pro-inflammatory cytokines will be reduced in the mothers and infants receiving the higher DHA diet.

Eligibility Criteria:
Inclusion Criteria:

•Lactating mothers at Cincinnati University Hospital with infants born at \< 29 weeks gestation.

Exclusion Criteria:

* the presence of congenital anomalies (trisomy 13, 18, 21, urethral, gastrointestinal and cardiac defects) that affect the standard course of care.
* mother's \<18 and
* mothers with known allergy to algeal source
* mothers with history of bleeding disorders or taking any other medication that may increase the risk of bleeding
* infants with bleeding disorders or receiving any other medication that may increase the risk of bleeding
The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

The purpose of this study is to determine the effects of SUVO on sleep, stress, and cue reactivity/craving and to evaluate the preliminary safety and side effects profile of suvorexant (SUVO)


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for MA use disorder
* Be fluent in English and able to understand the consent form

Exclusion Criteria:

* Have an alcohol use disorder or report binge drinking (\>7 drinks for women and \>14 drinks for men)
* Have a greater than mild substance use disorder on any other illicit substance
* Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
* Are currently taking medications with known drug interactions with SUVO (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
* Are pregnant or breast feeding
* BMI \> 30 (women only)
* Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
* Have history of seizure disorder
* Have a head injury with loss of consciousness in the last 5 years
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.

This is a cluster randomised trial set in rural Ethiopia with kebeles (villages) as the unit of randomisation. 54 kebeles will be included. 27 will be randomly allocated to the intervention arm (Facility based care (FBC) + Community-based Rehabilitation (CBR)) and 27 randomly allocated to the control arm (FBC alone).

The aim is to determine whether CBR + FBC is superior to FBC alone in reducing disability related to schizophrenia, measured by the WHO Disability Assessment Schedule version 2.0 (WHODAS 2.0) at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using (DSM-IV) criteria
* Evidence of severe, enduring or disabling illness
* Resident in kebele for \>6 months and no immediate plans to leave the kebele
* Has a primary caregiver who is willing to participate in the study

Exclusion Criteria:

* No specific criteria
Acromegaly Treatment Quality of Life Study

The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria:

* Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
* Initiation or discontinuation of testosterone or estrogen within 3 months of entry
* Pregnant and nursing women