cyrilzakka/clinical-trials huggingface dataset:
PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
2. Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
3. ECOG PERFORMANCE STATUS 0-1.
4. Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
5. No co-morbidities known to affect radiotherapy reactions.
6. No co-existing acute or chronic skin disease.
7. No evidence of infection or inflammation of breast to be treated.
8. Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

Exclusion Criteria:

1. Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
2. Prior radiotherapy to any site.
3. Collagen vascular disease.
4. Diabetes mellitus requiring medication.
5. Uncontrolled hypertension.
6. Participation in other clinical study.
7. Any contra-indicating to treatment with Melatonin.
8. History of allergy to peanuts or fragrances.
9. History of severe allergic reactions (e.g. asthma).
In Vitro Maturation of Immature Oocytes

The aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS
* Women with previous Hyperstimulation or with risk of developing hyperstimulation during IVF Treatment
* Women diagnosed with cancer who are interested in fertility preservation
* Women with repeated IVF failure

Exclusion Criteria:

* Severe cases of endometriosis
* Large myomas
* Hydrosalpinxs Technical problem with previous oocytes pick-up
Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women

Human safety studies were carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) was given with four selected FDA-approved drugs to determine if the red clover supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predicted that the red clover supplement might affect the metabolism or break down of these probe drugs.

At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants took the red clover dietary supplement twice orally daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement were evaluated to determine if metabolism of the probe drugs was impacted by the red clover dietary supplement.

Eligibility Criteria:
Inclusion Criteria:

* healthy peri- and post-menopausal women ages 40 - 79
* non-smokers
* no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
* no medical condition that requires chronic use of medication

Exclusion Criteria:

* known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or red clover
* positive pregnancy test
* use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
* use of caffeine products 7 days before study participation or during the study
* use of citrus products 7 days before study participation or during the study
* other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
* chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
* unwillingness to comply with study requirements
* current participation in another clinical trial
* CYP2D6 deficiency based on phenotyping at screening
* smoker
* red clover or soy intake (whether as a botanical dietary supplement, food, drink or otherwise) within the previous two weeks and during the study
* use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
* extreme obesity (defined as \>40 BMI)
* alcohol or drug abuse
* chronic diseases such as diabetes.
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea

Background. Atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (CABG) surgery and usually associated with increased length of hospital stay and higher hospital costs. Among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with Holter.


Eligibility Criteria:
Inclusion Criteria:

* apnea-hypopnea index \> 15 events/hour

Exclusion Criteria:

* ejection fraction \< 45%
* chronic atrial fibrillation
* periprocedural instability (haemodynamic, neurological)
Use of Alternative and Complementary Medicine by Colorectal Cancer Patients

Complementary and alternative medicine (CAM) is defined by the National Center for Complementary and Alternative Medicine as "a group of diverse medical and health systems, practices and products that are not currently considered part of conventional medicine" (Complementary, Alternative, or Integrative Health, n. d. 2012). Complementary medicine is used to complement conventional medicine, and alternative medicine is used instead of conventional medicine (Dy et al., 2004). These are two very different approaches, whose consequences for a cancer patient can be completely different. The use of CAM is steadily increasing in most countries. A study carried out in France in 2017 revealed that for half of CAM users, the diagnosis of cancer was one of the main factors that led patients to turn to CAM (Sarradon-Eck et al., 2017). CAM use was found to be significantly associated with younger age, female gender and higher education (Sarradon-Eck et al., 2017). The source of information about MAC was mainly friends/family and the media, while doctors and nurses played a succinct role in MAC information (Molassiotis et al., 2005). The most frequently cited reasons for using CAM were to improve their physical well-being, strengthen their bodies, improve their emotional well-being and relieve the side effects of treatment (Sarradon-Eck et al., 2020). Another study carried out in 2019 at nine centers in France showed that 45% of glioma patients had changed their eating habits after glioma diagnosis, 44% were on complementary treatment, mainly vitamins and dietary supplements, and 32% were using alternative medicine, mainly magnetism and acupuncture. A total of 68% reported using at least one of these approaches (Le Rhun et al., 2019). Another single-center study conducted in France in 2019 found that 83% of cancer patients used CAM (M et al., 2019). CAM included osteopathy, homeopathy, acupuncture, therapeutic touch, magnetism, naturopathy, cupping, Chinese medicine, reflexology and hypnosis. However, no studies have been carried out to assess the use of CAM among colorectal cancer (CRC) patients in France.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with colorectal cancer
* To be operated on between 2017 and 2022

Exclusion Criteria:

* The patient refuses to give consent to participate in the study
* Non-primary colorectal cancer (metastasis to the colon or rectum from another primary cancer; cancer originating in the appendix)
* Primary metastatic cancer other than colorectal cancer
* Discovery of cancer synchronous with colorectal cancer
* Guardianship or trusteeship
* Cognitive disorders (Alzheimer's, dementia, etc.)
* Severe psychiatric disorder (neurodevelopmental disorder, psychotic disorder, mood disorder, etc.) according to the specific DSM-5 and ICD-11 classifications
* Severe deafness (unable to answer questions during telephone interview)
Brain Development Research Program

Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are studying the genetic causes of disorders of cognition and epilepsy, in particular disorders of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of the investigators' research is to use a better understanding of the underlying genetic causes as a foundation to develop better treatments for these groups of patients.

We are studying both the genetics and clinical features of these disorders. We hope to understand the problems faced by individuals with these disorders as well as their causes. In the future, we hope to develop therapies that are geared specifically for individuals based on the underlying biology. To participate in the study, you will be asked to provide a copy of the magnetic resonance imaging (MRI) documenting Agenesis Corpus Callosum (ACC), Polymicrogyria (PMG), or Dandy-Walker malformation (DWM), clinical information, and saliva or blood samples from the affected individual and from the parents. Please see contact information and our webpage below.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of agenesis or dysgenesis of the corpus callosum, polymicrogyria, or Dandy-Walker malformation
* Should be confirmed by an MRI (Magnetic Resonance Imaging) of the brain

Exclusion Criteria:

* Fully formed but hypoplastic corpus callosum
Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial

The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known.

Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients.

This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone.


Eligibility Criteria:
Inclusion criteria (all):

* Male or non-pregnant, non-nursing female
* \> 18 years of age and \< 75 years of age
* Patients classified as having RA (according to new ACR/EULAR criteria)
* Disease duration less than 2 years (defined as time from 1st joint swelling)
* The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
* The patient has taken no prior DMARD
* Patients able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria (any):

* Abnormal renal function (serum creatinine \> 142 µmol/L in female and \> 168 µmol/L in male)
* Abnormal liver function, active or recent hepatitis, cirrhosis
* Major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases.
* Leukopenia and/or thrombocytopenia
* Inadequate birth control conception, pregnancy, and/or breastfeeding
* Indications of active tuberculosis
* Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
CT for Diagnosis of Implant Stability in Revision Arthroplasty

All patients over 18 who undergo a revision of hip or knee arthroplasty will be included. Patients undergo a CT of the hip joint. A radiologist will mark the presence of cysts and bone loss and will assess implant stability.

After the surgery, the surgeon will fill a similar form.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted for hip or knee revision arthroplasty
* age over 18

Exclusion Criteria:

* fractures
* dislocations
Zoledronic Acid in MS-patients With Osteoporosis

This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. Primary objective is the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region assessed by T-Score at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.


Eligibility Criteria:
Inclusion:

* Written informed consent to participate in the trial
* Definite diagnosis of Multiple Sclerosis (MS) as defined by 2005 revised McDonald criteria
* MS-subtype: Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Primary progressive MS (PPMS)
* Expanded Disability Status Scale (Kurtzke's scale; EDSS) score between 2.5 to 6.5 (including both)
* Bone mineral density (BMD) T-score of less or equal to -2.0 and more or equal to -4.0 at the lumbar spine (L1-L4 with at least 2 evaluable vertebrae) and/or total hip region and/or femoral neck in recent Dual X-Ray Absorptiometry (DXA)-scan (\< or = 3 months)
* Sufficient ability to read, write and communicate comprehensibly and comply to study procedures
* No immunomodulatory treatment for MS within the last 30 days or stable and well tolerated therapy with any beta-interferon formulation, or glatirameracetate or fingolimod for at least 30 days immediately prior to baseline

Exclusion criteria:

* Contraindications against Calcium and Vitamin D and zoledronic acid according to the summary product characteristics
* More than one osteoporotic fracture
* Concomitant medication with influence on bone mineral density (eg. enzyme- inducing antiepileptics like Carbamazepin, Phenytoin, Phenobarbital, Primidon)
* Any neurological disorder other than MS which is known to affect bone mineral density (e.g. muscular dystrophy, severe paresis for other reasons than MS, degenerative nervous disorder, stroke)
* Women who are pregnant or breast feeding, or menstruating and capable of becoming pregnant.
* Baseline renal insufficiency
* 25-OH vitamin D level \< 10 ng/ml at screening
* Serum calcium levels \> 2.75 mmol/l (11.0 mg/dL) or \< 2.00 mmol/L (8.0 mg/dL) at screening
* Other protocol-defined inclusion/exclusion criteria may apply
The Effect of the Tidal Model in Diabetes Patients

Aim:

In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.

Population of the Research: The population of the research will be individuals who applied to Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of the research: The sample of the research is; In calculating the number of samples, the study of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was taken as reference.At the end of the Tidal Model application, the effect size was calculated as 0.652 based on the difference between the self-esteem scores. In this context; A power of 0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to take a total of 60 individuals, with a sample size of 30 individuals in the intervention and control groups. Sample size is based on independent t-test. It was decided to include more than 20% of the sample number calculated in terms of losses during the implementation of the study and statistical analysis. Accordingly, 36 intervention and 36 control groups will beResearch data

Literature-based Personal Information Form will be collected using Diabetes Distress Scale Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written permission from the institution and written permission from the participants were obtained.In the study, in which the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10 individual interviews will be held with the individuals in the experimental group in addition to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The control group will continue to receive routine treatment and follow-up. In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the objectives of the research. Considering the basic processes of the Tidal Model, stages of care, basic approach and Tidal competencies, an interview plan including the details of the interviews with diabetes patients will be created and a meeting plan will be made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews, depending on the situation of the individuals. tried to be formed. The number of samples was calculated in the G\*Power 3.1 program.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.

Exclusion Criteria:

Patients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.
Effects of Lifeskills Workshop on BP in Hypertensive Employees

A number of psychosocial risk factors have been strongly related to a range of health problems (chief among them CVD). Clinical research has shown that behavioral interventions have enormous promise to ameliorate the psychosocial distress, the health-damaging effects and the costs associated with these risk factors. However, few such programs have been implemented in a large-scale way. Corporations are increasingly interested in providing such services for their employees, but they have encountered difficulties in knowing which programs are most effective. Until these programs are developed as products that can be tested and shown to produce consistent benefits, dissemination of these beneficial programs will be hindered. Taken together, these findings make a strong case that the development of a standardized, protocol-driven behavioral intervention package that can be delivered in a wide range of corporate settings presents a remarkable commercial opportunity. The overall goal of this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost effective manner in a corporate setting. This empirical support, tested in a setting independent of the program developers and by an experienced research team, will then be used to help market the product in the corporate wellness marketplace. It is hypothesized that participants (employees in an urban medical center) in the LifeSkills intervention will experience greater reductions in blood pressure and improvements in measures of psychosocial well-being than those receiving usual medical care and given educational materials on reducing BP.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-75
* Employees of Columbia University Medical Center
* BP \>= 140/90 on 2 occasions (average of 3 readings each time)

Exclusion Criteria:

* Pregnancy
* End-stage Renal disease
* BP \> 165/110 (average over 3 readings)
Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer

The present study evaluates prospectively the impact of robotic surgery on functional outcome and quality of life in older patients that are operated for colorectal cancer;


Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 70 years with colorectal cancer
* eligible for colorectal surgery after multidisciplinary board evaluation and patient consent

Exclusion Criteria:

* decline in cognitive function after geriatric evaluation
* emergency surgery
* life expectancy \< 3 months