cyrilzakka/clinical-trials huggingface dataset:
Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops

Elevated intraocular pressure is still the main risk factor for development and progression of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous patients. However, some patients cannot reach the target pressure despite a multitherapy with a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a natural compound that is a receptor-independent adenyl-cyclase activator, that increases intracellular cAMP. It has been shown to be able to decrease IOP after topical application, by a mechanism that is not used by the other drugs. Aim of the present study is to see whether oral administration of a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG patients with stable IOP obtained by treatment with either beta-blockers or prostaglandins.


Eligibility Criteria:
Inclusion Criteria:

* Primary Open Angle Glaucoma associated with ocular hypertension
* Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins)
* Visual acuity \> 6/10

Exclusion Criteria:

* Miopy or Hypermetropy \> 5D
* Concomitant ocular pathologies
* Previous ocular surgery
* Known hypersensitivity to any of the components in the KRONEK tablets
* Concomitant participation in other trials
* Changes of topic glaucoma therapy during the course of the study
Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<75
* Colon study indicated for colo-rectal carcinoma screening
* After colonoscopy for any indication failed due to technical causes
* Patients who decline an indicated colonoscopy

Exclusion Criteria:

* Significant heart failure (NYHA grade III-IV)
* Renal failure (Creatinine \> 1.2 mg/dl)
* Known or suspected intestinal strictures
* Known or suspected mesenteric adhesions
* History suggestive of bowel obstruction
* Vomiting and/or aspirations
* Symptoms of dysphagia
* Pace-maker or AICD implanted
* Known allergy or intolerance to any of the study drugs
* Pregnancy
* Illicit drug abuse or alcoholism
* Inability to provide an informed consent
Mechanisms of Altered Ventilatory Control in Heart Failure

This study is being done because the investigators are trying to understand how feedback from the muscles can influence your blood pressure and breathing during exercise, and if the investigators can reduce this response in heart failure patients. The investigators are also trying to determine ways to improve tolerance to exercise in heart failure patients.

If you are enrolled in this study the investigators will ask you to make 3 separate study visits.

During study visit 1 you will be asked to get a blood draw, DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece.

During study visits 2 and 3 you will be asked to again exercise at maximal exertion while breathing into a mouth piece. However, during these two visits you will be receiving an intrathecal injection of fentanyl one day and placebo the other day, randomly selected and you will be blinded as to which you are receiving. A catheter will also be placed in an artery in your arm and a vein in your leg, which will help us to measure blood flow, blood pressure and draw blood when need be. The investigators will also ask you to perform a brief chemosensitivity test, breathing in and out your own air, after you are done exercising.

Eligibility Criteria:
Inclusion Criteria (Heart Failure Patients):

* History of ischemic or idiopathic dilated cardiomyopathy
* New York Heart Association class 1-3
* No history of dangerous arrhythmia's
* Not pacemaker dependent
* Body Mass Index less than or equal to 35 kg/m
* Current non-smokers with less than 15 pack year history
* Non-pregnant women
* Individuals who are able to exercise without orthopedic limitations
* All patients will be managed by their primary care physician or cardiologist prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.

Control Participants:

* Will be matched for age, gender, height and weight and will have no history of cardiovascular related abnormalities.
* Body Mass Index less than 35 kg/m
* Current non-smokers with less than 15 pack year history
* Non-pregnant women
* Individuals who are able to exercise without orthopedic limitations
Rural CT Examination and Thrombolytic Treatment for Stroke

To counteract long term sequelae from stroke, ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation is required. In this study, the investigators are moving the essential first diagnosis and treatment out into the community close to where the patient live, thus shortening the all important time from debut of symptoms to thrombolytic treatment improving the prognosis of stroke patients.

Stroke is an acute, potentially mutilating disease. To counteract long term sequelae three factors are essential: Ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation. Initial diagnosis and treatment has up to now been completed within the hospital domain. This study will change that: moving the essential first diagnosis and treatment out into the community close to where the patient lives thus shortening the all important time from debut of symptoms to thrombolytic treatment. We will operate a local computer tomography (CT) service in the hands of community based non-specialized health care personnel (MD and nurse) acting under direct telemetric guidance from on call hospital specialists. Thus, the investigators will show that by combining current technological advances in real time video communication with an acutely well functioning cooperation between the community and hospital health service personnel the prognosis of stroke patients is improved.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years being investigated by CT within 24 hours for acute symptoms of stroke.
2. Fullfilling criteria for the diagnosis acute stroke as described by the Norwegian stroke registry.
3. Giving informed consent.

Exclusion Criteria:

1. Symptoms not due to ischaemic or haemorrhagic stroke as adjudicated at discharge.
2. Not able to cooperate to 3 months follow up.
3. Not giving informed consent
Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer

In this study, a large-scale cohort of cervical cancer patients was established in multiple centers. Minimal residual disease(MRD) was assessed by ddPCR detection of HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence, so as to provide new biomarkers for precise treatment of cervical cancer patients. The study continued until 36 months after the end of treatment.

The purpose of this study is to assess MRD by detecting HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence. According to the treatment methods, the patients were divided into two groups :(1) initial surgical treatment group (2) initial concurrent chemoradiotherapy group.

After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary.

Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up.

The primary endpoint is Disease-free survival (DFS, time from the treatment initiation to disease progression). Secondary endpoints include HPV ctDNA state before treatment, dynamic change trend of HPV ctDNA after treatment and overall survival (OS, time from the treatment initiation to death).

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis: cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma
* FIGO stage: IA2-IVA
* HPV typing: type 16 or 18
* ECOG 2-0
* The initial treatment was surgery (Cohort A) / concurrent chemoradiotherapy (Cohort B)

Exclusion Criteria:

* The diagnosis of cervical cancer was made within 3 years of other malignancies
* Pregnant or lactating women
* Refused to sign a consent form
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness.

Approximately 48 participants will take part in the study across the United States.

The study treatment (NLS-2 or placebo) will be administered for 8 weeks. After this treatment period, the participant may have the option to participate in a separate long-term extension study during which all participants will be treated with NLS-2.

This is a Phase 3, double-blind, placebo-controlled, multicenter, randomized, parallel-group clinical trial. The primary goal of this study is to assess the efficacy and safety of NLS-2 (mazindol extended-release) tablets in treating Narcolepsy Type 1. The trial aims to determine the effects of NLS-2 on the improvement of narcolepsy symptoms, including cataplexy frequency and excessive daytime sleepiness.

Participants in this trial will receive either NLS-2 or a placebo for 8 weeks. The treatment assignment will be concealed from both the participant and the investigator throughout the trial (unless there is an urgent medical need).

Approximately 48 patients will be enrolled at multiple clinical sites across the United States. Following the completion of the trial, participants may be given the option to enroll in a separate long-term extension trial where all participants will receive NLS-2 treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Adults ≥ 18 years of age at the time of signing the informed consent.
* Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria.
* Willing and able to safely discontinue all prohibited medications, including medications for the treatment of narcolepsy.
* Body Mass Index (BMI) within the range of 18 - 40 kg/m2 (inclusive).

Key Exclusion Criteria:

* Any other (besides narcolepsy) clinically relevant medical, behavioral, or psychiatric disorder that is associated with excessive daytime sleepiness or cataplexy.
* History of myocardial infarction or significant cardiovascular disease, structural cardiac abnormalities, cardiomyopathy, congestive heart failure, cardiac arrhythmias, coronary artery disease, cerebrovascular disease (transient ischemic attack or stroke), or any other significant cardiac problem.
* History of long QT Syndrome or Torsades de Pointes, or an immediate family history of sudden cardiac death.
* History of pulmonary hypertension and/or valvulopathy.
* History of epilepsy, convulsions, or seizures (excluding early childhood febrile seizures).
* Significant history of head injury or head trauma.
* Recent or active suicidal ideation or behavior
* Current, or within the past year, diagnosis of substance abuse or dependence disorder (SUD) including alcohol abuse.
* Narrow-angle glaucoma.
* Severe renal or hepatic insufficiency.
* Occupation that requires variable or nighttime shift work.
Effectiveness of Mindfulness Based Meditation on Well-being, Self Compassion & Cognizance Among Nurses Working in Intensive Care Units

Effect of Mindfulness Based Guided Meditation on Intensive care Unit nurses wellbeing,cognizance \& self compassion was assessed .

: Primary objective To assess the Effectiveness of Mindfulness Based Guided Meditation on Wellbeing, Self Compassion and Cognizance among Nurses working in Intensive Care Units at ILBS.

Hypothesis

The following hypothesis will be tested at 0.05 level of significance:

H1There will be a significant difference between pretest Wellbeing scores and posttest Wellbeing scores of Nurses working in Intensive Care Units. H2There will be a significant difference between pretest Self Compassion Scores and posttest Self Compassion scores of Nurses working in Intensive Care Unit.

H3There will be a significant difference between pretest Cognizance Scores and posttest Cognizance score of Nurses Working in Intensive Care Units.

H4 There will be a significant relationship between Wellbeing and Self Compassion Among Nurses working in Intensive Care Units.

H5 There will be a significant relationship between Wellbeing and Cognizance among Nurses working in Intensive Care Units.

H6 There will be a significant relationship between Self Compassion and Cognizance Among Nurses working in Intensive Care Units.

H7 There will be a significant association of posttest wellbeing score with selected Socio demographic variables of Nurses working in Intensive Care Units.

H8 There will be a significant association of posttest Self Compassion score with selected sociodemographic variables of Nurses working in Intensive Care Units.

H9 There will be a significant association of Posttest Cognizance score with selected sociodemographic variables of Nurses working in Intensive Care Units.

Research Design Pre-experimental, one group pre test -post test design

Eligibility Criteria:
Inclusion Criteria:

* Registered nurses who were Working in ICUs for at least last three months continuously.

Exclusion Criteria:

* Registered nurses who were On long leave Had joined recently in ICUs
Hemp 15 mg & 50 mg Capsule Absorption

This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.

This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This study is designed to include two arms. Each arm will be delivered a different concentration of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of the study all participants will be asked to provide four (4) plasma samples, 10 randomly selected participants will be asked to provide five (5) plasma samples. Samples will then be evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in order to determine time to reach maximum blood concentration. This trial is double-blinded with two arms enrolling only healthy individuals. The participants randomized for a fifth blood draw will be randomly selected from these two arms.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Ages 18 - 65.
4. In good general health as evidenced by medical history as indicated by oral confirmation of study participant.
5. Ability and willingness to suspend the use of any other herbal dietary supplements for 48 hours prior the first clinical visit associated with this study.
6. Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.
7. Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.
8. Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.

Exclusion Criteria:

1. Current use of regular medication for a chronic condition.
2. Current pregnancy or lactation.
3. Plans to become pregnant during the intended duration of the study.
4. Known allergic reactions to hemp flower.
5. Known severe food allergies.
Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.


Eligibility Criteria:
Inclusion Criteria :

* Age \> 18 ans
* OMS = 2
* Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Exclusion Criteria:

* Contraindication to coelioscopy intervention
Short Course Radical Cure of P. Vivax Malaria in Nepal

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite.

In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.

The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Eligibility Criteria:
Inclusion Criteria:

* P. falciparum and/or vivax infection
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Age \>1 years
* G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines
* Written informed consent
* Able to comply with all study procedures and timelines

Exclusion Criteria:

* General danger signs or symptoms of severe malaria
* Anaemia, defined as Hb \<8g/dl
* Pregnant women as determined by Urine β-HCG pregnancy test
* Breast feeding women
* Known hypersensitivity to any of the drugs given
* Regular use of drugs with haemolytic potential
* Blood transfusion within the last 4 months
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Children aged 9-months- 5 years at first screening.

Exclusion Criteria:

* Known diagnosis of diabetes (Type 1 or other)