cyrilzakka/clinical-trials huggingface dataset:
Sustainable Early Episode Clinic Study (SEEC)

The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).

Schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. Recognizing the need for improved early treatment for participants diagnosed with Schizophrenia or Schizoaffective Disorder, a model was created for a "sustainable early episode clinic, SEEC." The goal of the SEEC model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. This study will last for up to a 36-month period.

Eligibility Criteria:
Inclusion Criteria - Participants

* Participants must be at least 18 years or older
* Participants within 5 years of a clinical diagnosis of Schizophrenia or Schizoaffective disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for these disorders
* Participants must be able to speak, read, and understand English
* Participants must sign an informed consent form

Inclusion Criteria - Caregivers

* Caregivers must be 18 years or older Caregivers must also be willing to attend the multi-family psychoeducation group series (Phase I)
* Caregivers must be willing to participate in monthly family therapy and/or monthly phone contact with staff for the duration of the study
* Caregivers must sign informed consent form

Exclusion Criteria - Participants

* Co-occurring developmental disabilities
* Receiving electroconvulsive therapy
* Primary substance use disorder
* On permanent conservatorship
* Unable to complete baseline assessments due to acuity of psychiatric symptoms

Exclusion Criteria - Caregivers

* Caregivers who refuse to participate in the psychoeducation series of Phase 1
* Caregivers who refuse monthly family therapy/phone contact with staff will be excluded
* Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by treatment team
* Caregiver is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)

The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).


Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment into this study, subjects must meet all of the following criteria:

* Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
* Written informed consent
* Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects will not be included in the study if they meet any of the following:

* Body mass index ≤22 kg/m2 at the completion of study OB-303
* Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
* Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
* Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).
Primary TBE Vaccination for the Elderly

Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals \> 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those \> 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 50 years or between 18-40 years
* Man or woman
* God health
* Written informed consent

Exclusion Criteria:

* Previous vaccination against TBE
* Previous TBE infection
* Allergy or hypersensitivity to any substance in the vaccine
* Previously known or suspected infection with Japanese encephalitis, Dengue virus, West Nile fever or Yellow fever
* Information on previous vaccination against Yellow fever or Japanese encephalitis
* Acute illness, eg fever with malaise
* Immunosuppression, due to medication or disease
* Previous treatment with Rituximab or equivalent
* Autoimmune disease, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c \< 6 %)
* Obesity, BMI \> 40
* Moderate to severe renal failure including hemodialysis, estimated GFR \< 30.
* Blood transfusion or immunoglobulins \<3 months ago
* Pregnancy
* Any other illness where the investigator consider the subject unsuitable for the study
* The study subject does not want to participate
Impact of COVID-19 on Psoriasis Practice

COVID-19 had a major impact on dermatology practice globally with special emphasis on chronic diseases e.g. psoriasis. The main objective of this work is to investigate the effect of COVID-19 pandemic on psoriasis management.

This work is designed as a cross-sectional survey based on a questionnaire directed to Egyptian dermatologists.


Eligibility Criteria:
Inclusion Criteria:

* Egyptian Dermatologists
Coffee Interaction With the Antihypertensive Drug Felodipine

Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world.

Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago.

We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* healthy (normal physical exam, blood clinical chemistry)
* willingly signs ethics approved informed consent form

Exclusion Criteria:

* history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse
* significant illness within 2 weeks of starting study
* history of allergy to felodipine , tablet ingredients or dihydropyridines
* routinely taking prescription or OTC drugs or natural health products
* received an investigational drug withing the previous 4 weeks
* females who are pregnant or breast-feeding
The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.


Eligibility Criteria:
Inclusion Criteria:

* The patients treated in the diabetology department of CHU de Reims during the inclusion phase to a diabetic foot lesions ( infected or not).
* Patients with care of this lesion of diabetic foot externally.
* Patients who agreed to participate in or accepting ORNICARE network ( network for the transmission of information between health care professionals) (Appendix 3) .
* Patients aged over 18 years .
* Patients who agreed to participate in the study .
* The patients insured by a social security scheme .

Exclusion Criteria:

* Patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...).
* Patients are protected by law .
* Minor patients.
Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to lidocaine
* Women refuse to participate in the study
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

This study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.

Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections.

Patients who have received prior injections and are scheduled to continue regular injections will be randomized to utilize one of four types of anesthetic treatment for each of 4 treatment periods,so that each subject receives all four types of anesthesia over the course of the study. The order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. This will decrease the effect of extraneous variables from influencing subjective pain scores.

Following each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving both the anesthesia and the injection(on separate 0-10 scales).

The anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine.

The subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 40 years of age
* Diagnosis of age-related macular degeneration
* History of at least 1 intravitreal injection in the past in either eye
* Written informed consent has been obtained

Exclusion Criteria:

* Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)

PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.

The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal

PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.

The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 36 years old
* Female patient with PCOS (Rotterdam criteria)
* Failure of treatment with Clomiphene Citrate
* Informed consent
* Female patient with medical assurance
* Patient in failure with PCOS and Clomiphene citrate

Exclusion Criteria:

* Female patient is over 36 years old
* Thyroid disease (4\<TSH\<0.3 mUI/L)
* Virilizing tumor
* FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
* Anormality of SPERMOGRAM (abnormal time of migration of survival)
* Prolactin \> 1.5 N
* Anormality of 17-OH Progesterone (\<2 ng/mL)
* Fallopian tubes non permeable TMS\< 5 Millions
* Female patient participant or have been participated to another clinical trial during the last month before the inclusion
* Female patient without medical assurance
Poor Theoretical Knowledge and Self-assessed Ability of Cardiopulmonary Resuscitation Among In-hospital Healthcare Professionals: a Cross Sectional Study With Questionnaires.

Theoretical knowledge of cardiopulmonary resuscitation (CPR) is the foundation of being able to perform CPR in a cardiac arrest situation. The knowledge and skills received in training is easily lost and after one year the level is equal to pretraining. International studies regarding knowledge of CPR among healthcare professionals, mostly nurses, show poor results. The knowledge of CPR among Swedish healthcare professionals is poorly studied.

The aim of this study was to describe the theoretical knowledge of CPR and self-assessed abilities of performing CPR among healthcare professionals working in four hospitals in Sweden.

A questionnaire will be handed out containing a knowledge test of nine questions at a basic level. The questionnaire also contains Likert-scales that measures four self-assessed CPR abilities of the respondents (the ability to take leadership, give compressions, to ventilate and to defibrillate).

Eligibility Criteria:
Inclusion Criteria:

* Healtchare professionals of all professions
* Working in-hospital with patient contact
* Present at the time of the survey

Exclusion Criteria:

* Not working with patients
* Abscent at the time of the survey
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypotension
* Other exclusion applied
Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease

Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.

Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.

Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years
* Hemorrhoidal pathology, anal fissures and anitis
* NRS score ≥ 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body)

Exclusion Criteria:

* Known hypersensitivity to study products
* Proctitis
* Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
* Surgical treatments undergone less than a year after inclusion
* Pregnancy, breastfeeding
Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies

Oncologic patients often report increased fatigue during and after chemotherapy. Evidence suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with chemotherapy. Previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and reducing inflammation (4).

The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.

Tai-chi/Qi-gong is a complementary medicine technique that synergizes the mind-body connection. The technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion.

The effect of Tai-chi/Qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. This trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. The patients will be allocated according to their preference to either the study or the control group. The Tai-chi/Qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. All patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Women with gynecological malignancies undergoing primary or secondary chemotherapy

Exclusion Criteria:

* Motor disability;
* Less than 1 month since the last abdominal surgery;
* Ascites