cyrilzakka/clinical-trials huggingface dataset:
Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of type 2 diabetes
* obesity BMI \>35

Exclusion Criteria:

* prior bariatric surgery
Testing of a New Computer Screen for Patients With Persistent Concussion Symptoms (PCS).

This study will examine whether a newly designed monitor for computers is better tolerated by concussed patients than the standard computer monitor. The information gathered from this study will contribute to the understanding of the persisting concussion symptoms including computer screen intolerance and photosensitivity, with the aim of helping those with concussions.

The study will involve completing a reading task on the standard computer monitor and the newly designed computer monitor. First, participants will be asked to rate their pre-test symptoms using a SCAT-III symptom checklist. Then they will read a short story and watch moving images on one of the devices (standard computer monitor or the newly designed computer monitor) for 30 minutes or until persisting concussion symptoms of moderate severity arise. Then, they will be asked to rate their post-test clinical symptoms using a SCAT-III symptom checklist. On a second visit, 7 to 10 days later, they will do the same activity on the other device. Each visit will take 60 minutes.

The study will involve 100 patients with a history of concussion and computer screen intolerance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of persisting concussion symptoms (1 month to 5 year since concussion)
* Must speak English
* Must provide written consent
* No alcohol/recreational drug use within 24 hours of intervention
* No other neurological, psychiatric or ocular conditions

Exclusion Criteria:

* No diagnosis of Persisting Concussion Symptoms
* Under the age of 18, over the age of 65
* Other neurological/psychiatric or ocular conditions
* Alcohol or recreational drug use within 24 hours of intervention
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed treatment in Trial CVL-865-SZ-001 (NCT04244175)
* A female participant of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent through 30 days post last dose
* A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with the investigational medicinal product (IMP)
* Participants who are capable of giving signed informed consent
* Participants who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures

Exclusion Criteria:

* Participants who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial
* Participants who, in the judgment of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the participant may not be appropriate for 57 weeks of treatment with CVL-865 in an extension trial
* Participants who experienced status epilepticus during Trial CVL-865-SZ-001
* Participants who have demonstrated substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial
* Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent), or participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), or participants who, in the opinion of the investigator, present a serious risk of suicide
* Participants with any of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary (Females: Hemoglobin \<11 gram per deciliter (g/dL); Males: hemoglobin \<12 g/dL; White blood cell (WBC) count \<3.0 x 10 power 9 per liter (10\^9/L); Neutrophil count \<2.0 x 10\^9/L; Platelet count \<150 × 10\^9/L)
* Participants who would be likely to require the use of prohibited concomitant medications during the trial
* Female participants who have a positive pregnancy test result
Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.


Eligibility Criteria:
Inclusion Criteria:

The subjects will have to meet all the following inclusion criteria:

1. Subjects agree to participate in the study and having dated and signed the informed consent form.
2. Male or female aged ≥ 18 years and ≤ 70 years old.
3. LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
4. TG\<400 mg/dL.
5. Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid- lowering intervention.
6. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.

Exclusion Criteria:

Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:

1. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk \> 5%;
2. Obesity (BMI\>30 kg/m2) or diabetes mellitus;
3. Assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
4. Antihypertensive treatment not stabilized for at least 3 months;
5. Anticoagulant therapy
6. Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
7. Known current thyroid, gastrointestinal or hepatobiliary diseases;
8. Any medical or surgical condition that would limit the participant adhesion to the study protocol;
9. Abuse of alcohol or drugs (current or previous);
10. History of malignant neoplasia in the 5 years prior to enrolment in the study;
11. History or clinical evidence of inflammatory diseases such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
12. History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
13. Known previous intolerance to one component of the tested nutraceuticals or to one of these plant species: Asteraceae or Compositae;
14. Women in fertile age not using consolidated contraceptive methods
15. Pregnancy and Breastfeeding.
Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy

The improvement of comprehensive multi-modality treatment and radiotherapy (RT) technology has resulted in an improved survival rate of head and neck malignancies within recent decades. As survival increases, late toxicity from cancer therapy becomes a larger burden. Radiation induced vascular injury following RT is a recognized complication of radiotherapy. Diagnosis of vascular changes predominately relies on non-invasive imaging techniques. Doppler ultrasound assessment has been proven as a good indicator of diffuse atherosclerotic disease and a significant predictor of future vascular events. New opportunities are provided by the recent introduction of the hybrid PET/MRI scanners for investigating the synergistic effect of these two modalities without the challenge of image co-registration. It has been shown that the PET system integrated with the MRI scanner performs the same as the PET portion of a PET/CT for various cancers and cardiovascular indications. MRI allows better delineation of the carotid artery and atherosclerotic plaque when compared with CT due to the superior soft tissue contrast. The PET/MRI system acquires the PET and MRI simultaneously allowing for perfect alignment between the 2 sets of images, when compared with the sequential acquisition in PET/CT where minor head movements can cause misalignment. There is evidence in the literature that 68-Ga DOTA-TATE PET-imaging can serve as a surrogate marker for evidence of invasion into the vessel wall and thereby possibly detects early, developing atherosclerotic plaque. Thus, combined PET and MR with 68-Ga DOTA-TATE should be a promising imaging tool to screen and characterize patients at risk for radiation induced carotid injury.

In this study, DOTATATE-PET/MR will be performed in up to 60 patients with a history of radiation therapy for head and neck squamous cell carcinoma over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* previously treated with radiation for head and neck malignancy;
* Age Group: ≥30 years;
* Patients who have no contraindications to PET/MRI;
* No allergy to contrast agents.

Exclusion Criteria:

* Pregnant females;
* Age group: \< 30 years;
* Allergy to MR contrast agents;
* Pacemakers/ICD/Claustrophobic patients.
Turkish Version of The Sitting Balance Scale

The aim of this study is to investigate the validity and reliability of the Turkish version of the Sitting Balance Scale in stroke patients.

The Sitting Balance Scale is primarily designed to measure the sitting balance in fragile elderly individuals who cannot stand up. It has also been validated in individuals with stroke and consists of 11 items. Each item is graded from 0 to 4. The highest score that can be obtained is 44. Low test scores indicate impaired sitting balance.

The necessary permissions were obtained from the authors for the Balance of Sitting Scale, whose validity and reliability features will be tested, and the questionnaire was finalized by completing the translation process into Turkish. The basis of the use of special instruments such as scales is to prove their usability in the sample group to which the instrument will be applied. The first step for this is the translation from the original language to another language.

During the translation process into Turkish, two experts who have good command of English translated the questionnaire from English to Turkish. These translations were translated back into Turkish by two native speakers and distant medical subjects. In addition, these translations were re-examined by the researchers and turned into a single form. This form, which was sent to five experts in the field, was checked for content and its suitability for Turkish was evaluated. With the opinion of experts, the scale took its final form.

The study will include individuals over the age of 18 who applied to Kastamonu Training and Research Hospital and diagnosed with ischemic or hemorrhagic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Diagnosis of stroke,
* Not having a cooperation and communication problem,
* At most 6 months have passed after stroke.

Exclusion Criteria:

* Other neurological or orthopedic problems that affect functionality and balance other than stroke.
* Having advanced cardiovascular disease and contraindication for mobilization
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.


Eligibility Criteria:
Inclusion Criteria:

* Induction of labor is indicated
* Gestational age between 24 - 42 weeks
* Singleton pregnancy
* Bishop score less than 7

Exclusion Criteria:

* Any contraindication for vaginal delivery
* Previous cesarean delivery
* Low lying placenta
* Rupture of membranes
* Fetal malformations incompatible with life
* intrauterine fetal death
* Amnionitis
* Genital viral infection (HIV, hepatitis C virus

  , hepatitis B virus)
* Allergy to latex
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth

This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.


Eligibility Criteria:
Inclusion criteria are:

* Singleton gestations
* No prior SPTB

Exclusion criteria are:

* Multiple gestations
* History of SPTB in a prior pregnancy
* Rupture of membranes at the time of randomization
* Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
* Fetal death at the time of randomization
* Cerclage in situ at the time of randomization
* Pessary in situ at the time of randomization
* Vaginal bleeding at the time of randomization
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
Manual Small Incision Cataract Surgery Outcomes in an Educational Setting

The overall objective is to determine the visual outcomes and cost to perform Manual Small Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the United States. The primary outcome measure will be the percentage of the study group achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed in academic centers. A secondary outcome will be to determine the actual institutional cost of providing MSICS in the setting of an academic medical center. The hypothesis is that MSICS is appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or better at 90 days post op, as compared to PCS), and can be provided at a cost that makes visual rehabilitation affordable to the uninsured and underinsured.

The investigator will perform a study of a pilot implementation of portions of the Aravind method of promoting access to care and provision of surgical services in the setting of an academic medical center teaching program. Target enrollment is 100 subjects having cataracts. Potential subjects will be identified through vision screening programs and if cataracts are found they will be offered MSICS at a price deemed to be affordable by individuals without insurance.

A survey of Pima County providers found that $3500 was the lowest price offered to a self-pay patient for one-stage cataract extraction (CPT 66984) for PCS facility fee, surgeon fee, and anesthesia fee. The expectation is that MSICS can be delivered in a teaching environment at a cost of $500. The investigator wishes to determine if this price point is sustainable and if a continuing model of cataract visual rehabilitation service delivery can be safely, affordably, and ethically delivered to those who cannot afford to pay, while integrating resident education and autonomy into the delivery model.

The proposed outcome measure is the proportion of eyes that see 20/40 or better while wearing glasses for those participants that do not have comorbid conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years or older (adults).
2. Medically Stable, able to safely undergo surgery.
3. Nuclear sclerotic cataract
4. Preoperative best corrected visual acuity (BCVA) 20/80 or worse
5. Expected post-operative potential acuity of 20/40 or better
6. Able to pay the $500 cost of surgery at the time of surgery

Exclusion Criteria:

Potential subjects not satisfying any of the above
GameSquad for Adults With Down Syndrome

The investigators are assessing acceptability, appropriateness, and feasibility of the adapted GameSquad-DS intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Specifically, the investigators will assess mins/wk of Ring-Fit Adventure played, attendance at 30 min. virtual health coaching sessions, semi-structured interviews, participant retention, and intervention safety measured as number of adverse events.

Adults with DS face unique barriers to participation in MVPA. Exergames, which integrate MVPA into video game play are an affordable, accessible, home-based exercise program which has shown effectiveness for increasing MVPA and improving both physical and cognitive function in typically developed populations. An exergaming intervention with individual health coaching called GameSquad has been shown to be effective in improving MVPA and cardiometabolic parameters in children with overweight/obesity and adolescents with neurodevelopmental and psychiatric diagnoses. The investigators propose a two phased project to adapt/evaluate the GameSquad intervention for use in adults with DS (GameSquad-DS). In Phase 1, the investigators will utilize a formative approach to develop GameSquad-DS, pilot test the intervention for 4 weeks in 10 young adults with DS and use feedback to refine the intervention for use in Phase 2. In Phase 2, the investigators will conduct a 12-wk. single arm pilot trial in 20 young adults with DS to assess the acceptability, appropriateness, and feasibility of the intervention and calculate effect sizes for change MVPA, physical function, muscular strength, physical activity enjoyment, and self-efficacy. Successful completion of this project represents an initial step in achieving the goal of developing effective interventions to increase MVPA and promote healthy aging in adults with DS.

Eligibility Criteria:
Inclusion Criteria:

* Young adults (18-30 yrs.).
* Diagnosis of DS.
* Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
* Living at home with a parent/guardian or in a supported living environment with a parent/caregiver who agrees to serve as a study partner.

Exclusion Criteria:

* Unable to participate in MVPA.
* Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by their primary care provider (PCP).
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.


Eligibility Criteria:
Inclusion Criteria:

1. Must have any one of these three disease categories:

   * Idiopathic Pulmonary Arterial Hypertension

     * Mean pulmonary arterial pressure (PAPm) \> 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and PVRI\> 3 u•m\^2 or diagnosed clinically with no previous catheterization
   * Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired

     * PAPm \> 25 mmHg at rest and PVRI\> 3 u•m\^2 or diagnosed clinically with no previous catheterization
   * Cardiomyopathy

     * PAPm \> 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)\> 3 u•m\^2 or diagnosed clinically with no previous catheterization
2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
3. Male or female, ages 4 weeks to 18 years, inclusive
4. Signed informed consent/assent

Exclusion Criteria:

1. Focal pulmonary infiltrates on chest radiograph.
2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
3. Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
4. Pregnant \[urine human chorionic gonadotropin positive (HCG +)\]
5. Baseline Pulmonary capillary wedge pressure (PCWP) \> 20 mmHg