cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

The primary objectives of the study are:

1. To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of \>15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation.
2. To compare the proportion of patients who achieve a successful response to treatment (reduction in IOP of \>15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation.

The study is a prospective, observational cohort study and will not provide or recommend any treatment. Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up after enrollment targets have been reached.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with open-angle glaucoma who have a new or change in therapy (decision to proceed to laser or incisional surgery or initiate a new or additional course of medication).
* Includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation.
* Patients willing to complete visual function and quality of life questionnaires

Exclusion Criteria:

* Patients currently treated with four or more glaucoma medications (at time of enrollment).
* Patients with no light perception, or otherwise not eligible for further treatment
* Patients who have neovascular glaucoma, patients with uveitis-associated glaucoma, or patients with angle recession glaucoma.
* Patients with primary angle-closure or secondary angle-closure glaucoma
* Patients who have had prior incisional surgery for glaucoma
The Prevalence of CTX Disorder in Juvenile Cataract Cases in Turkey

Epidemiologic observational study. Study will include two phases:

1. Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are planned to be determined.
2. Prospective phase: At this stage of the study, identified juvenile cataract cases as a result of retrospective screenings will be called to be invited to the sites and blood samples will be obtained for the cholestanol tests for the cases that have given Informed Consent.

This observational study is designed in two phases; retrospective and prospective. Retrospective part includes screening the patient database and / or patient files at ophthalmology clinics participating in the study and identifying patients diagnosed with idiopathic juvenile cataracts. The data of patients with idiopathic juvenile cataracts will be reviewed and the data of the patients meeting the inclusion/exclusion criteria will be recorded. Once this phase is completed, the prospective phase of the study will start and the patients meeting the criteria will be invited to the site to participate in the study. Current data will be collected from the patients who agree to participate in the study and the clinical status of the patients will be evaluated according to the Mignarri index. In addition, blood will be obtained from all patients to diagnose CTX disease. Blood samples will be sent to Duzen Laboratories in Ankara and analyzed for cholestanol.


Eligibility Criteria:
Inclusion Criteria:

* Providing the written informed consent form
* The patient should be diagnosed with idiopathic bilateral juvenile cataract
* Idiopathic bilateral juvenile cataract should be diagnosed while the patient must be take a day from one year (age)
* Syria ciziten who take their citizenship of Turkey could be enrolled to the study after signing of Informed Consent Form that translated to mother tongue by sworn translation office approved by ethic committee.

Exclusion Criteria:

* If the patient has been diagnosed with CTX before his/her enrollment in the study,
* If the patient has been diagnosed with cataract due to any known reasons other than CTX including cataracts related to trauma,
* If the patient has been diagnosed with cataract due to cataractogenic treatments,
* If the patient has participated in an interventional clinical study within the last 30 days,
* If the patient and/or his/her legal representative does not provide consent to participate in the study,
* If the patient will not be able to fulfill study requirements according to the investigator's opinion,
* If the patient had used cholic acid or chenodeoxycholic acid on or before the date of participation in the study
* Pregnancy and/or lactation
* Syria citizen that have not Turkey citizenship will not enroll to the study.
Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria

This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.

This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.

All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-\<12.5. High Risk MAM will be defined with a MUAC 11.5 to \<11.9 or WAZ\<-3.5 or Mother not the caretaker or not breastfeeding at \<2 years old. Low risk MAM defined with a MUAC 11.9 to \<12.5 with no risk factors.

Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.

High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.

A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and \<12.5)

Exclusion Criteria:

* currently involved in another research trial or feeding program
* medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
* have a diagnosed or visible sign of developmental delay
* have a history of peanut or milk allergy
Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys

The purpose of this study is to determine if whole body vibration exercise improves insulin/glucose dynamics and bone metabolism in Latino Boys.


Eligibility Criteria:
Inclusion Criteria:

* Boy 8-10 years of age
* Tanner Stage I
* Age and gender BMI \> 85th percentile
* Hispanic descent( all four grandparents of Hispanic descent)

Exclusion Criteria:

* Acute or chronic illness
* Any condition known to influence body composition, or insulin/glucose dynamics
* Musculoskeletal disease, injury, or orthopedic condition that would prevent exercise
Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity: a NutriQuébec Sub-study

The unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Therefore, the primary aim of this NutriQuébec sub-study is to document the impacts of the COVID-19 pandemic on diet quality and food insecurity of adults in the province of Québec in Canada.

NutriQuébec is a web-based prospective cohort study launched in June 2019 whose primary aim is to provide data for the evaluation of the Government Health Prevention Policy on the Québec population's eating habits over the years (NCT04140071). Participants of NutriQuébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. Questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status.

For the purpose of this sub-study, NutriQuebec will invite the 2465 active participants who completed the first-year questionnaires prior to the COVID-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in April and May, 2020. This NutriQuébec sub-study will provide invaluable data on how the COVID-19 pandemic impacts diet quality and food insecurity of adults in the province of Québec.

The 2465 active participants of NutriQuébec who completed the first-year questionnaires prior to the COVID-19 pandemic will be invited to provide informed consent to participate in this sub-study. Once having consented, participants will be invited to complete the core questionnaires by logging into their personal and secured account. Participants will have a three-week period to complete the questionnaires, from April 16 to May 7, 2020.

Core questionnaires in NutriQuébec assess lifestyle habits including eating habits, physical activity habits, sleep quality, tobacco, alcohol and drug habits as well as pandemic behaviors, personal characteristics, food insecurity, health status and health-related quality of life. Most of these questionnaires are based on a one-month recall timeframe, with the exception of the eating habits questionnaires, which is in the form of repeated 24-h recall. For the purpose of this NutriQuébec substudy, questionnaires were adapted to focus on habits during the last 7 days of questionnaire completion, to reflect more specifically the confinement period.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over with a residential address in Québec (Canada)
* Be able to read and understand French or English
* Have access to Internet (with a computer, electronic tablet or cell phone)
* Have an active email address

Exclusion Criteria:

* None
MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine the biochemsty in the border zone and structural MRI for vascular malformation. We repeat structural MRI after 8 weeks.

In this study we want to investigate the ability of MRI to identify underlying pathology (tumor or vascular malformations) in acute patients admitted with intracerebral hemorrhage (ICH). Today MRI-scan is normally done 3-4 weeks after symptom onset but very little is known about the early use of MRI to detect underlying pathology. This would allow an early intervension and less uncertainty for the patients.

We further want to investigate the metabolic penumbra-zone surrounding the hematoma. It is the current perception in the litterature that this zone represent a metabolic zone marked by apoptosis and inflammation rather than ischemia.

We are planning to:

When patients arrive in our stroke department they will within 7 hours be subject to MRI scan with the protocoled sequences. Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair og axial GRE-sequence.

Susceptibility weighted imaging (SWI)

Chemical Shift Imaging (CSI) multivoxel spectroscopi

Post contrast 3D box reconstruction

After 8 weeks the patients are subject to another MRI-Scan in accordance with the standard clinical guideline to rule out underlying pathology.

After 3 month the patients are seen in the outpatient-clinic to follow-up evaluation.

To sum up the purpose of this present study is to conduct a pilot investigation of MRI in the early evaluation of ICH-patients. Second it is our intension to use multivoxel magnetic resonance spectroscopy to study the metabolic penumbra-zone surrounding the ICH.

Eligibility Criteria:
Inclusion Criteria:

* CT demonstrated ICH
* Cardiopulmonary stable
* Informed consent from patient or proxy
* No General contraindication of MRI
* Age above 18

Exclusion Criteria:

* Lack of informed consent
* lack of cooperability
Clinical Feasibility of a New Voice Prosthesis

The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.


Eligibility Criteria:
Inclusion Criteria:

* Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
* 18 years and older

Exclusion Criteria:

* Current tracheoesophageal puncture problems such as enlarged puncture or infection
* Active recurrent or metastatic disease (medical deterioration)
* The use of ActiValve Strong/XtraStrong or XtraSeal
* Unable to understand the Patient Information and/or unable to give Informed Consent
* The previous 2 VPs had a device lifetime \> 12 months
* History of oral resections negatively affecting speech
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin

To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
* Normal or non-diagnostic OGD and colonoscopy
* Informed consent
* Patients presented with shock will be resuscitated for urgent endoscopy

Exclusion Criteria:

* Patients remained in shock despite resuscitation.
* Moribund patients
* Terminal malignancy
* Presence of pacemaker or ICD
* Suspected or confirmed intestinal obstruction
* Swallowing difficulties
* Renal failure that preclude angiographic examination
* Pregnancy
* Age \<18
* Refused consent
Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness for tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Crohn's disease.

Exclusion Criteria:

* As per SmPC
The Neuromarker S-100B in Patients With Different Types of Intracranial Injury

Abstract:

The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive and validate the measurement of S-100B in serum of patients with different types traumatic brain injuries.

The neuromarker S-100B is a well established tool for decision making in patients traumatic brain injury (TBI)in Europe. In many hospitals S-100B is used routinely as a part of a set of high- and medium risk factors aiding the decision to perform a cranial computed tomography (CCT) in patients with minor head injury (MHI). In patients with severe head injury Raabe et al. found a significant correlation between the S-100B levels and unfavourable outcome in patients with severe brain injury with serum levels higher than 0.50 μg/l measured 24h after injury. The average level of the neuromarker, compared with other studies. The study of Biberthaler et al. showed highest levels in patients with epidural hematomas, followed by subdural, subarachnoidal and intracerebral hematomas. On the contrary the average S-100B levels of patients with epidural hematomas featured in a study by Unden et al. published in 2005 displayed normal levels (\<0.2 μg/L). They concluded that S-100B was unreliable as a marker for epidural hematomas.

Aim of the study Validation of S-100B in patients with intracerebral, epidural, subdural, and subarachnoidal hematoma, brain edema and concussion (Group 1-6), to find evidence which kind of injury leads to which level of elevation of the neuromarker measured in peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* all patients with traumatic brain injury

Exclusion Criteria:

* patients without traumatic brain injury
5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

This study aims to evaluate the improvement of autoimmune status in patients with Type 1 Diabetes (T1D) through supplementation with 5-Methyltetrahydrofolate, and to explore the safety and efficacy of this treatment. The research seeks to provide new methods for the treatment of T1D and offer innovative ideas for enhancing the quality of life of T1D patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis.
2. Aged 13-65 years, regardless of gender.
3. Duration of T1D ≤ 5 years.
4. Retained residual islet function, defined as fasting C-peptide \> 0.1 nmol/L \[0.30 ng/mL\] or postprandial 2-hour C-peptide \> 0.2 nmol/L \[0.60 ng/mL\].
5. Determined by the investigator to be capable and willing to: perform self-monitoring of blood glucose (SMBG); complete patient logs as required; receive diabetes education; and comply with the study treatment and visit schedule as per the protocol.

6) Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.

Exclusion Criteria:

1. Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
2. Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
3. Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
4. Received immunosuppressive or immunomodulatory therapy within the past year.
5. Comorbid with other autoimmune diseases, such as systemic lupus erythematosus.
6. Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases.
7. Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues.
8. Malignancy.
9. Recent surgery or significant stress.
10. Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients.
11. Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities.
12. Currently participating in another clinical trial.
Proprioception, Physical Performance, and Passing Accuracy in Adolescent Basketball Players

The relationship between elbow proprioception, upper extremity physical performance, and passing accuracy in adolescent basketball players will be explored.

Proprioception is defined as transmitting the sense of the position of our body, interpreting incoming information about posture, and performing the movement to be done consciously or unconsciously. It is critical in controlling and coordinating goal-directed multi-joint movements. It is crucial to learn and perform the sport-specific techniques correctly to increase performance in training and competitions.

Recently, the interest in basketball has increased, and the number of adolescents participating in this sport has increased at the same rate. Passing is the most widely used technical skill after shooting in basketball. A basketball player's performance and a team's success mainly depend on their passing skills. Because passing in basketball is one of the important actions in the game. It has been stated that the error/success ratio of the player on the passing skill is the main distinguishing factor between beginners and experienced players in competitions.

For this reason, the performance and season-long success of the players in basketball depend mainly on their passing skills. The Physical Performance Tests can be used to determine functional performance and evaluate progression in athletic populations. It has become necessary to conduct studies investigating basketball passing to improve training capacity, the performance, and skills of players.

Some studies in the literature investigate the possible relationship between proprioception and sportive success. One of them emphasized the relationship between free throw percentage and shoulder joint position sense. They also stated that proprioceptive exercises (especially above 90° of the shoulder ROM) could be included in the training program to increase the percentage of free throws. On the other hand, one study examined the relationship between basketball players' free-throw performance, elbow, and wrist joint position sense and found a moderate correlation between free-throw success rate and wrist and elbow joint position sense.

The studies on upper extremity proprioception in basketball players mainly focus on examining free-throw performance, and there is no study examining the relationship between proprioception and passing accuracy. In addition, no research has been found exploring the relationship between upper extremity physical performance and proprioception in basketball. Therefore, this study hypothesizes that a player with good elbow proprioception and upper extremity physical performance tests would have high pass accuracy, considering the importance of passing in basketball.

Eligibility Criteria:
Inclusion Criteria:

* Those who are between the ages of 13-18
* Those who have licensed active basketball players
* Having verbal and written communication skills in Turkish

Exclusion Criteria:

* Refusal
* Having had any upper extremity surgery
* Having a diagnosis of any upper extremity musculoskeletal conditions