cyrilzakka/clinical-trials huggingface dataset:
Online Interventions for Gamblers With and Without Co-occurring Mental Health Concerns

Comorbidity between problem gambling and mental health concerns such as anxiety and depression is common. Further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern. The present study is a two-arm, double blinded, parallel group randomized controlled trial (RCT) that will evaluate whether there is a benefit to providing access to mental health Internet interventions (G+MH intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring mental health concerns.

People with gambling concerns will be recruited using targeted advertisements. Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus one that contains interventions for anxiety and depression in addition to an intervention for gamblers (G+MH). It is predicted that problem gamblers who do not have co-occurring mental health concerns will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health concerns, it is predicted that participants receiving access to G+MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)

Exclusion Criteria:

* None
Folic Acid and Creatine as Therapeutic Approaches for Lowering Blood Arsenic

The purpose of this study is to determine whether folic acid, alone or together with creatine supplementation, can lower blood arsenic concentrations and improve the ability to detoxify arsenic.

Approximately 140 million people in over 70 countries are chronically exposed to arsenic (As)-contaminated drinking water at concentrations far exceeding the World Health Organization standard of 10 µg/L. As is a carcinogen known to cause cancers of the skin, bladder, and lung, as well as ischemic heart disease and neurologic impairments. Methylation of ingested inorganic arsenic (InAs) to methylarsonic-(MMA) and dimethylarsinic acids (DMA) relies on folate-dependent one carbon metabolism, utilizing S-adenosylmethionine (SAM) as the methyl donor, and facilitates urinary As elimination. The results from our Nutritional Influences on Arsenic Toxicity (NIAT) study indicate that folate deficiency and hyperhomocysteinemia (HHcys) are associated with a reduced capacity to methylate arsenic and are risk factors for arsenic-induced skin lesions. Furthermore, folic acid (FA) supplementation does indeed facilitate As elimination and significantly lowers blood As concentrations in individuals who are folate deficient. We have also determined that blood As is a good biomarker of As exposure and is directly associated with the risk for As-induced skin lesions. Collectively, the implication of these findings is that FA has enormous therapeutic potential for ameliorating the long-term health consequences of arsenic exposure for the many populations at risk. However, several fundamental questions remain and will be addressed in this study. This trial is designed to determine 1) whether FA supplementation lowers blood As concentrations in the general Bangladeshi population, 2) at what time point a nadir in blood As is achieved, and 3) whether creatine supplementation, alone or in addition to 400 µg/d FA, will spare methyl groups, resulting in lower blood As, lower homocysteine (Hcys) concentrations, and increased methylation of As. The creatine arms are based on multiple studies that show that urinary creatinine concentrations are a very strong predictor of As methylation. The final step in creatine biosynthesis is the methylation of guanidinoacetate to creatine; this process consumes 50-75% of all SAM-derived methyl groups and is also responsible for 50-75% of all Hcys biosynthesis. Thus, this trial will test the hypothesis that creatine supplementation, which shuts down endogenous creatine biosynthesis, will spare methyl groups, lower Hcys, and increase As methylation.

Eligibility Criteria:
Inclusion Criteria:

* Currently exposed to arsenic via contaminated drinking water
* Well water arsenic concentration \> 10 ug/L
* Between the ages of 20 and 65

Exclusion Criteria:

* Women who are currently pregnant or plan to become pregnant within the next 6 months
* Currently taking nutritional supplements
* Known renal disease
* Participation in any other clinical trial
The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia

The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH and more than one billion individuals are thought to be infected, of which 450 million have significant morbidity attributable from their infection, school-aged children in particular. In this population infections cause stunting of the linear growth, anemia, reduce the cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are highly prevalent, affecting more than 60% of the children (data not published).

Current efforts to control STH infections involve periodic mass drug anthelmintic treatment of infected children in endemic areas and are likely to intensify as more attention is addressed to the importance of these neglected diseases. Monitoring drug efficacy in these control programs has become indispensable in order to detect the emergence of resistance and/or identify confounding factors affecting the drug efficacy. Recently a study has evaluated a single dose albendazole (ALB) in school age children across 7 countries, including Ethiopia, revealing that this regime is highly efficacious for the treatment of A. lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate. Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose 10mg/kg), of which the latter holds promise as it can also be administrated to children between 6 months and 2 years. The main objective of the present study, therefore, is to assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x 500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).


Eligibility Criteria:
Inclusion Criteria:

* all school age children who are eligible to participate in the study

Exclusion Criteria:

* Not willing to participate (no informed consent)
* Unable to give samples for follow up
* Severe intercurrent medical condition
* Diarrhea at first sampling
* Study subjects who had treatment for STH in the last 3 months
Visualization of the STN and GPi for DBS

The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi.
* Subject is 18 years or older.
* Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures.

Exclusion Criteria:

* Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery.
* Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps.
* Subject's life expectancy is less than one year.
* Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition.
* Subject is pregnant or interested in becoming pregnant during the duration of the study.
* Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults

This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults aged 19 - 55 on Visit 1
* Those without clinically significant abnormalities on the screening test on Visit 1
* Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
* Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives

Exclusion Criteria:

* Those who participated in other studies and took investigational products/ investigational vaccines within 6 months from Visit 1
* Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
* Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
* Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b
Coaching Doctors in Ethical Decision-making (CODE)

Over the last few decades the fast technical and medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Previous studies suggest that doctors (unconsciously) prefer to remain prognostically uncertain rather than to gather the information that is required to reduce uncertainty and to effectively timely take decisions in the team for the benefit of the patient. To obtain all that information, the doctor in charge of the patient needs to empower clinicians to speak up while guarantying a safe environment. However, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires specific self-reflective and empowering leadership skills (including the management of group dynamics in the interdisciplinary team).

The aim of this study is to investigate whether coaching doctors in self-reflective and empowering leadership, and in the management of team dynamics with regard to adult hospitalized patients potentially receiving excessive treatment during 4 months 1) improves ethical decision-making (primary objective) and 2) reduces the burden on patients, relatives, clinicians and the society (secondary objective). The improvement in quality of ethical decision-making will be assessed objectively via the incidence of written do-not-intubate and -resuscitate orders (first primary endpoint) in patients potentially receiving excessive treatment and subjectively via the ethical decision-making climate questionnaire that will be filled out by the team (second primary endpoint). In line with the DISPROPRICUS study, patients potentially receiving excessive treatment will be defined as patients who are perceived as receiving excessive treatment by two or more different clinicians in charge of the patient. The probability of being alive, at home with a good quality of life one year after admission was only 7% in patients potentially receiving excessive treatment in this study. Therefore, perceptions of excessive treatment by two or more clinicians are used in this study as a signal to initiate (self-)reflection in team about the quality of care that is provided to the patient and whether the treatment is in balance with the medical condition of the patient and the patient's goal of care

.


Eligibility Criteria:
Inclusion criteria

1. Clinicians' level : doctors (including department head) and nurses (including head nurses) taking care of adult hospitalized patients in the 10 participating departments
2. Patients' level : first hospitalization of adult patients who are potentially receiving excessive treatment.
3. Family level : family of adult patients who are potentially receiving excessive treatment

Exclusion criteria :

1. Clinicians'level : no exclusion criteria
2. Patients' level : patients who cannot understand Dutch questionnaires
3. Family : persons who cannot understand Dutch questionnaires
Photodynamic Therapy for Permanent Hair Removal

24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60

Exclusion Criteria:

* anormal behavior
* pregnancy
* pathologic skin conditions
* medication that my interfere with the study
* allergy against the photosensitizer
* lack of compliance
* other reasons considered important by the investigator
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
2. PD Hoehn and Yahr stage 2-4;
3. Pittsburgh Sleep Quality Index (PSQI) score \>5 in group 1, and ≤5 in group 2;
4. Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and \<10 in group 2;

Control participants will be matched for gender and age with PD participants.

Exclusion Criteria:

1. Atypical or secondary forms of Parkinsonism;
2. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
3. Presence of depression defined as the Beck Depression Inventory (BDI) score \>14;
4. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
5. Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
6. Use of medications known to affect melatonin secretion;
7. Unstable/serious medical illness.
Levator Muscle Strength Evaluation

The purpose of this study is to assess a new technique of measurement for the levator muscle.

this measurement may be applied during a clinical evaluation of eyelid malposition.

our purpose is to quantify the levator muscle strength and to corelate it to standard levator muscle strength assessment techniques routinley used in the oculoplastic clinic.

This study will include patients refered to our oculoplastic department for evaluation of eyelid disorders (ptosis or eyelid malpositions due to various mechanical, muscular, neurogenic factors).

all patients will be over 21 years old, with eligibility for signing an informed concent form.

all patients will undergo a full clinical standard evaluation of eyelid malposition made as part of the routine evaluation of eyelid malpositions. as part of this evaluation- the levator muscles strength will be measured by monitoring the amount of millimeters of difference between the uper lid closed and open position (a regular technique for levator muscles assessment).

a second levator muscle strength evaluation will include the study device. this device is used for weight evaluation of objects. an object is measured by attaching it to the device with a metal hook and a string. the device is hand held.

for measurements of the upper lid force the device will be temporarily attached to the upper eyelid using a specially designed base made in the shape of the eyelid. the attachment will be using a sterile medical tape (plaster). this sterile base is attached to the outer eyelid and does not involve in any point any harm to the continuity of the skin, injections , harm or contact to the eyeball or any other parts of the eye. this base is attached from its back to a string witch attaches to the measuring device. the investigator holds the measuring device and asks the patient to open and close his eyes. the force that is generated while opening the upper lid is measured (in grams) by the device.

this evaluation will allow a unique first proper estimation of the true levator palpebra strength. it will be compared to the levators' strength as estimated using the routine techniques for assessing their efficacy.

the assessment will be made one time for each patient. after the measurement- the sterile tape will be removed and will be disposed. no further interventions will be made for each patient.

Eligibility Criteria:
Inclusion Criteria:

eligible for signing an informed concent form refered for eyelid evaluation in the oculoplastic department, Meir Mc

Exclusion Criteria:

previous eyelid surgery
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis

A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee

This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology (ACR) criteria, including:
* Symptoms for at least 6 months prior to screening, AND
* Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
* The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.

Exclusion Criteria:

* Body mass index (BMI) \> 40
* Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
* Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery

Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to investigate the optimal local anesthetic volume (20 mL versus 30 mL) with ESP block for open-heart cardiac surgery.

In cardiac surgery, the most common cause of pain during the first two days postoperatively is median sternotomy. In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively, postoperative 24 hours pain scores ranging from 5.3 to 6.5 out of 10 with deep breathing and coughing were shown. In these patients, it may increase the frequency of atelectasis due to reasons such as failure in pain control, weak coughing, and limitation of movement, and these may lead increase in morbidity and hospital stay. Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain, they are far from being ideal analgesics alone due to their side effects such as kidney damage, bleeding risk, sedation, respiratory depression, itching, nausea, and vomiting. The complications of neuraxial techniques seem to be the disadvantages of these methods. Erector spinae plane (ESP) block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries.

The Erector spinae plane (ESP) block was first described by Forero in 2016. In this block technique, a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process. The dorsal and ventral branches of the spinal nerves are blocked in this plane. However, due to individual regional anatomical differences, there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur. Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue.

This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Exclusion Criteria:

* Emergency surgeries
* Patients with allergic reactions to anesthesia and analgesia drugs to be used
* Patients who do not want to participate in the study voluntarily
* Severe systemic disease (kidney, liver, pulmonary, endocrine)
* Substance abuse history
* History of chronic pain
* Psychiatric problems and communication difficulties
* Patients who need revision due to hemostasis in the postoperative period
* Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.