cyrilzakka/clinical-trials huggingface dataset:
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers

Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 25 and 45 and pre-menopausal;
* Non-lactating and not pregnant
* able to follow the schedule of procedures
* able to freely provide informed consent
* have clinically acceptable physical examination and safety laboratory studies

Exclusion Criteria:

* current use of any form of systemic contraceptive
* have self-reported irregular menstrual cycles
* intercurrent illness(es) detected on the screening physical
* unwilling or unable to use barrier methods of contraception
* have evidence of endometrial polyps or myomata on TVU/SIS that would interfere with endometrial thickness measurement
* detection of ovarian cyst(s) during adnexal examination on screening TVU/SIS measuring greater than 5 cm
* have history of, or current cancer, on any form exclusive of basal cell carcinoma
* BMI \>= 35
* history of alcohol or drug abuse in the past 5 years
* unwilling or unable to undergo study procedures within the necessary time frames
* history or current liver abnormalities as defined by ALT or AST \> 2X ULN
* treated or untreated diabetes defined as fasting blood sugar \>= 126 mg/dL
* untreated hypertension
* impaired renal function by estimated creatinine clearance \< 80mL/min
* have estradiol levels \< 20 pg/ml and FSH levels \> 40 mIU/mL or
* have a history of adverse reaction any aromatase inhibitor
Assiut University Registry for ACS Patients During COVID-19 Pandemic

To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic

In the face of the quickly evolving coronavirus disease 2019 (COVID-19) pandemic, many health-care systems around the globe have modified their routine management of patients presenting with acute cardiovascular emergencies including patients with ACS.A unifying theme in the new management strategies is the adoption of new restrictive measures to meet the challenges of increased risk of infection of health-care workers; limited numbers of beds, shortage of personal protective equipment (PPE), inadequate number of protected catheterization rooms; and the clinical overlap between ACS and COVID-19 infection in some of patients.

In developing countries, with an already strained health system due to economic problems, the situation is more challenging and needs the formulation of efficient protocols that can accommodate several medical and socioeconomic challenges.

Egypt, with an estimated population of 100 million, is facing exceptional challenges during the COVID-19 crisis. Because large scale use of polymerase chain reaction (PCR) test for SARS-CoV-2 in a large population is a problem, the prevalence of COVID-19 infection in Egypt is unknown. Furthermore, the supply of PPE falls far short of demands with lack of professionally protected cardiac catheterization rooms. With progression of the pandemic in such a large population, care of COVID-19 patients is expected to rapidly overwhelm the supplies, beds, and staff available in Egyptian hospitals.

The Cardiology Department in Assiut university hospital has revised the management protocols for ACS patients and implemented new management protocols both for patients with ST-segment elevation myocardial infarction (STEMI) and Non-ST-segment elevation acute coronary syndromes (NSTE-ACS).

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with symptoms or ECG indicative of acute coronary syndrome admitted to Assiut heart hospital

Exclusion Criteria:

* The only exclusion criteria is refusal of the patient to participate in the study
A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384)

This study will compare monotherapy with tenofovir to sequential therapy with pegylated interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3 treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B (hepatitis B surface antigen \[HBsAg\]-positive for \>6 months or evidence of chronic hepatitis B in liver biopsy)
* Elevated serum ALT level
* Liver biopsy or a non-invasive investigation within 12 months prior to randomization with Chronic Hepatitis B
* Treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment
* Compensated liver disease

Exclusion Criteria:

* Known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component of the study products
* Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
* Need for prolonged or frequent use of systemic acyclovir or famciclovir
* Previously received lamivudine or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog and were resistant to these drugs
* History of variceal bleeding or other GI bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, Grade III and IV esophageal varices unless banded or other clinical signs of hepatic decompensation
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
* Need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin B, and foscarnet)
* One or more additional known primary or secondary causes of liver disease, other than hepatitis B
* History of clinical pancreatitis
* Pregnant or breastfeeding
* Female participants of childbearing potential and male participants must be willing to use acceptable method of birth control.
* Medical condition that requires frequent or prolonged use of systemic corticosteroids
* Use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period
Impact of Immunonutrition on the Patients With Cystic Fibrosis

The primary objectives:

To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis

1. Safety of immunonutrition
2. The effect of immunonutrition on parameters of oxidative stress
3. The effect of immunonutrition on the inflammatory parameters
4. The effect of immunonutrition on nutrition status

Hypothesis

The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has been shown to positively modulate oxidative stress in the different clinical setting however it has not yet been evaluated inpatients with cystic fibrosis who frequently need some support by means of enteral nutrition. We anticipate that the substitution of routine enteral nutrition by immunonutrition will result in improving of oxidative stress parameters.

,

Method Crossover open study will take 16 weeks. The patients eligible for the study according to inclusion and exclusion criteria are going to be divided into 2 groups after signing the informed consent. In both groups their nutrition status, humoral and cellular immunity, respiratory system function and parameters of oxidative stress will be evaluated before entering the intervention.

Afterwards the patients are going to be divided into one group who will receive nutrition support using immunonutrition for the next 8 weeks while the second one will continue with their nutrition support using routine sipping support with no immunonutrition. According to our hypothesis oxidative stress parameters will improve in the group of patients on immunonutrition comparing to the other group. Afterwards the patients will change their nutrition support for another 8 weeks. The patients who took immunonutrition in the first half of study will switch back to routine sipping support and contrary the patients who were in the first part of study on routine sipping will take immunonutrition. After the end of this period of study we expect the return of oxidative stress parameters to the baseline values in the group of patients who took immunonutrition in the first half of study but who were returned to routine nutrition support and contrary the improvement of oxidative stress parameters in the patients who started to take immunonutrition in the second half of study.

The total energy support will be identical in both periods for each individual patient. After the first 8 weeks and after the completion of study the same examination are going to be evaluate as it was on the entrance to study.

Statistical analysis: means, SD, t-test, chi square test, Mann Whitney test, linear correlation and multilinear analysis

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis
* adult, elder 18 years
* enteral nutrition at least for the last 12 monthes

Exclusion Criteria:

* patient waiting for lung transplant
* patients with another life limiting disease-e.g. cancers
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone

To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2 spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients suffering from first-episode schizophrenia/schizophreniform disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 50 years old, antipsychotic-naive, non-agitated patients diagnosed with first-episode schizophrenia or schizophreniform disorder.

Exclusion Criteria:

* Evidence or history of clinically significant medical or non-medical impairment that, in the opinion of the investigator, would affect the safety of the patient or interfere with the evaluation of the trial results;
* Patients who have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug on the Screening urine toxicology test
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
* Subjects who have other diagnoses not related to the cancer which can cause anemia
* Known history of seizure disorder
* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
* Subject of reproductive potential who is not using adequate contraceptive precautions
* Concerns for subject's compliance with the protocol procedures
Effects of Animal-assisted Therapy on Brain-injured Patients

The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 25 patients over 24 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.

This study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.

Over a period of six weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 24 therapy sessions (12 experimental, 12 control) for each patient.

Each therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires.

The study takes place at REHAB Basel. Animal-assisted therapies will be held at the "Therapie-Tiergarten" at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship.

Patients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition.

Participation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.

Eligibility Criteria:
Inclusion Criteria:

* patient at REHAB Basel
* brain-injury
* willing to participate in animal-assisted therapies
* physical and psychological resilience and ability to go/be transported outside to the "Therapie-Tiergarten"
* ability to get in contact with the animal autonomously

Exclusion Criteria:

* medical contraindications:allergies, phobias, etc.
* no willingness to participate in animal-assisted therapies
* patient might present a danger to the animals (aggressive behaviour)
* patient's medication changes radically during the time of data collection
Metronomic Capecitabine in Stage III Gastric Cancer

The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion Criteria:

1. History of chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for R0 resection and D2 lymph node dissection.
5. Patients with stage IV gastric cancer
Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care

The present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. Participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. The investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life.

Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "emotional disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. However, research indicates that psychological treatment should be the first step when caring for these types of problems. The investigators expect that the results show that brief psychological therapies are more effective than pharmacological interventions. Moreover, it is expected that brief individual psychotherpay approach delivered in secondary care is more effective than brief group psychotherapy delivered in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Emotional Disorder

Exclusion Criteria:

* Severe mental disorder
* Substance use disorder
* Severe depression
EndeavorOTC™ Prospective Product Registry

The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.

All EndeavorOTC users who subscribe to EndeavorOTC are invited to participate in this product registry. Users must provide their informed consent and have an active subscription to the product at time of enrollment to participate. Study activities are emailed to participants at baseline, 1, 2, 3, 6, 9, and 12-months after enrollment. Study activities consist of an online survey and online ADHD assessment. All data are captured electronically and securely through commercial data capture platforms.

Eligibility Criteria:
Inclusion Criteria:

* Has an active EndeavorOTC™subscription
* Provide informed consent to participate in the registry

Exclusion Criteria:

* N/A
Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy

Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is introduced to patients with refractory symptoms or drug resistance. Considering the sternotomy and relatively high patients' tolerance required in myectomy, the potentially risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic septum, and the potential risk of conduction block after these two treatments, the development of new minimally invasive approach is warranted.

Previous researches have illustrated the effectiveness and feasibility of transcatheter radio frequency ablation for HOCM patients. By far, there has been no report on transthoracic laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid tumors treatment, including liver tumors and fibroid. Also our center has conducted several animal experiments to verify the feasibility of radio frequency/laser in septal myocardium ablation.

The purpose of this study is to lead echocardiography-guided transthoracic radio frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans for HOCM patients, and verify the safety and validity of intervention treatment in long term.


Eligibility Criteria:
Inclusion Criteria:

* Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation
* Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum
* Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication
* Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test
* Subject over 18 years old

Exclusion Criteria:

* Subject has non-obstructive hypertrophic cardiomyopathy
* Subject has combined cerebral vascular diseases
* Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting.
* Subject has end-stage heart failure
* Subject has intraventricular septal thickness (IVST) ≥ 30mm