cyrilzakka/clinical-trials huggingface dataset:
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents \< 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.


Eligibility Criteria:
Inclusion criteria:

* Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
* Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
* Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
* Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
* Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated.

Exclusion criteria:

* Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
* Has partial or generalized tonic-clonic seizures.
* Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
* Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
* Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
* Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
* Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
* Has taken any investigational drug within 12 weeks prior to the Screen Phase.
* Is sexually active.
* Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding.
* Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.
Presenting Summary Information From Cochrane Systematic Reviews

The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum).

The investigators will conduct a randomized control trial (RCT) with three different formats of the same systematic review summary (infographics, PLS and scientific summary). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation, plain language, and scientific language. The trial will be performed at the beginning of the 2016/2017 academic year, with first year university students as participants. The trial will be voluntary and anonymous. The survey will consist of 4 parts: 1) demographic data, 2) one format of the summary (randomly assigned), 3) comprehension test of the information given in the summary, 4) accessibility of information and overall satisfaction with the given summary assessed by survey and 5) health numeracy test. All materials will be in Croatian. The materials used in this research will be assessed by experts in order to confirm face validity of developed questions.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be first-year university students without experience with Cochrane review summaries, because prior familiarization with Cochrane summaries could make information uptake easier by those participants.

Exclusion criteria:

* Participants who give the positive answer to the survey question about familiarity with the Cochrane will be excluded from the study analysis.
Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.


Eligibility Criteria:
Inclusion Criteria:

* Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;
* Agree to participate in the study by signing the informed consent form.

Exclusion Criteria:

* Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;
* Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;
* Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;
* Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;
* Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;
* Do not present a mouth opening of at least 12mm required for the proper of the guided surgical kit together with the surgical guide;
* Do not present a band of keratinized tissue favorable for maintaining peri-implant health.
* Present motor difficulties that compromise adequate oral hygiene.
A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to treat metabolic and autoimmune diseases in mice. However, clinical trials performing prolonged fasting with more than 7 days have not been reported. Investigators conduct an open label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day fasting-like diet in the treatment of metabolic and autoimmune diseases.

Although fasting has been proved an effective approach to treat metabolic and autoimmune diseases in mice, prolonged fasting is difficult to implement in human-beings for the safety and feasibility reasons.

In this clinical trial, we will recruit metabolic and autoimmune diseases and then follow a traditional Chinese 21-day fasting-like diet process with extremely low calorie intake (about 5% of normal diet) and prolonged fasting-like period. Blood, urine, stool samples will be collected on day 0 (baseline), day 4, day 7, day 14, day 21 and day 51 after it started up. Therefore we can examine the changes of disease-associated physical indexes and metabolic biomarkers pre and post the 21-day fasting-like diet.

The purpose of the study is to ascertain the impact of the fasting-like diet during the 21 days. The investigators hypothesize that the 21-day fasting-like diet can reduce the biomarkers associated with aging and age-related diseases and benefit for the treatment of metabolic and autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥18 and ≤75 years;
* Subjects has a confirmed diagnosis of metabolic and autoimmune diseases, including high blood pressure, kidney stone, gall stone, hysteromyoma, fatty liver, psoriasis, and so on.

Exclusion Criteria:

* Subjects has a confirmed diagnosis of cancer;
* Females who are pregnant or nursing;
* Subject requires a prescheduled regularly administration of drugs;
* Subject has severe renal insufficiency;
* Subject has cardiac arhythmia.
Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring

Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.


Eligibility Criteria:
Inclusion Criteria:

PATIENT PARTICIPANTS:

* Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
* Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
* Have one or more objective measures of heart failure:

Radiological congestion.

* Elevated BNP ≥ 400 pg/mL or NT-proBNP ≥ 1000 pg/mL.
* Reduced left ventricular ejection fraction \<40% (or \<45%) in previous 12 months.

Diastolic dysfunction including tissue Doppler E/e' ratio \> 15 in previous 12 months.

* Pulmonary capillary wedge pressure \>20 mmHg.
* Diuretic therapy. The additional value of diuretic therapy (IV or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine HF will be discharged without diuretic.

CLINICIAN PARTICIPANTS:

To be eligible to participate, clinician participants (i.e. ED physicians, family physicians and monitoring nurse(s)) must have referred or have a patient enrolled in the TEC4Home monitoring service.

Exclusion Criteria:

PATIENT PARTICIPANTS:

* Physical barriers e.g. unable to stand on scales.
* Cognitive impairment (e.g. MMSE \<20), unless suitable caregiver support.
* Language (must be able to read and understand English), unless suitable caregiver support.
* Documented history of current and active substance misuse (within 3 months).
* Lack digital connectivity or landline phone connection.
* No regular care provider e.g. GP, or at least regular walk-in clinic.
* Existing intensive system of care: LVAD, transplant, dialysis.
* Anticipated improvement due to revascularization (PCI/CABG) or valve intervention during index hospitalization.
* Anticipated survival \<90 days. Active palliative care, less-than level III care, disseminated malignancy.

CLINICIAN PARTICIPANTS:

Clinicians who do not have patients enrolled in the TEC4Home service or who themselves are not involved in the implementation or operation of the TEC4Home monitoring service will not be eligible to participate.
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.

A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and capable of giving signed informed consent.
2. Male or female, age between 40-80 years.
3. Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
4. Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
5. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
6. Planning to receive single-level lumbar interbody fusion.
7. Willing and capable of adhering to the protocol and visit schedule.

Exclusion Criteria:

1. Prior surgical procedure at the involved or adjacent spinal levels.
2. Presence or prior history of inflammatory disease of the spine.
3. Presence or prior history of neoplastic disease of the spine.
4. BMI \<18.5 or BMI \>35.
5. Documented titanium allergy or intolerance.
6. Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
7. Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
8. Active local or systemic infection.
9. Female subject who is pregnant or lactating.
10. Serological evidence of positive human immunodeficiency virus (HIV) antibody.
11. HBsAg positive or HBeAg positive, along with positive HBV DNA test.
12. Serological evidence of HCV antibody, along with HCV RNA \> lower limit of detection.
13. Known drug or alcohol abuser.
Early Motion Following Carpal Tunnel Release

To objectively and subjectively assess two modes of commonly employed rehabilitation and confirm a superior method to treat patients following carpal tunnel release.

One of the problems following carpal tunnel release (CTR) for carpal tunnel syndrome, and all hand surgeries, is the debilitation in the postoperative period. This relates to muscle atrophy and joint stiffness due to immobilization or relative inactivity in the postoperative period. Specifically, patients suffer increased days off from work, lost wages, and difficulties with activities of daily living affecting the patient and society at large. CTR is a very common procedure in hand surgery making it easy to study and important to optimize the postoperative care.

The surgical procedure, carpal tunnel release, will be performed in a standard open fashion. In a random fashion, the patients will be placed into either of two rehabilitation groups following CTR with specifically different postoperative instructions after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of carpal tunnel syndrome
* Recommended for carpal tunnel release

Exclusion Criteria:

* Severe thenar weakness
* proximal neuropathy of the same arm.
* generalized peripheral neuropathy
* active psychiatric disorder
* chronic renal failure require dialysis
* reflex sympathetic dystrophy
* previous injury of affected wrist or median nerve
* simultaneous ipsilateral upper extremity surgery
* carpal tunnel syndrome with acute injury
Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.

Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.

The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.

Eligibility Criteria:
Inclusion Criteria:

* have body mass index (BMI) between 18.5 and 31 kg/m2
* free of metabolic and gastrointestinal disease

Exclusion Criteria:

* BMI less than 18.5 or greater than 31 kg/m2
* presence of metabolic or gastrointestinal diseases
Mother-Baby Study - Eating in the Absence of Hunger (EAH)

The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Eligibility Criteria:
The child is a participant in the observational study (NCT06039878).
Prevention of Recurrence in Depression With Drugs and CT

This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.

Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or chronic major depressive disorder

Exclusion Criteria:

* Current diagnosis of psychotic affective disorder
* History of nonaffective psychotic disorder
* Substance dependence last three months requiring detox
* Schizotypal, antisocial, or borderline personality disorder
Host Immune Response to Novel RNA COVID-19 Vaccination

To determine the antibody response level in patients with cancer to the COVID-19 vaccination.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
3. Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
4. Able to provide informed consent
5. Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.

Exclusion Criteria:

1. Previously documented COVID infection
2. Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
3. Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:

   * Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
   * Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\])
   * Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
4. Pregnant or breastfeeding
5. Unable to comply with study related procedures as determined by the study team.