cyrilzakka/clinical-trials huggingface dataset:
GlyT-1 Inhibitor Treatment for Refractory Schizophrenia

The etiology of schizophrenia remains unclear In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment.

To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.

The etiology of schizophrenia remains unclear. In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment. To date, there have been a few pilot studies exploring the efficacy of NMDA enhancers as adjuvant therapy for schizophrenia, for instance, D-serine (an endogenous agonist of the NMDA-glycine site). They were not only well-tolerated but also synergistic in improving positive, negative and cognitive symptoms in those receiving typical and atypical antipsychotics (except clozapine).

Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. Previous studies revealed that add-on treatment of D-serine or other agonists of NMDA receptor failed to give significant benefits in such patients. The primary goal of this study is to investigate the efficacy and safety of glycine transporter(GlyT)-1 inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* Poor response of clozapine treatment: a 12-week treatment of clozapine without satisfactory response: a severity score of Clinical Global Impression Scale(CGI)\>=4, a total score of Positive and Negative Syndrome Scale(PANSS)\>= 60, and a Scale for the Assessment of Negative Symptoms(SANS)score of \>=40. the doses of clozapine remain stable for at least 12 weeks prior to their enrollment in this proposed study,
* Agree to participate in the study and provide informed consent.

Exclusion Criteria:

* current substance abuse or history of substance dependence in the past 6 months
* use of depot antipsychotic in the past 6 months
* serious medical or neurological illness
* pregnancy
* inability to follow protocol.
The Effect of Plate Size on Food Consumption and Satiety

In this study, it was aimed to investigate the effect of plate size on food consumption and satisfaction levels in healthy women.

The effect of plate size on food consumption and satisfaction levels in healthy women aged between 19-35 years will be evaluated in this study. In addition to this, the relationship between the amount of food that women eat and their feelings of satisfaction will be evaluated. During the experiment, the individuals will be asked to consume the pasta with sauce which is offered in the open buffet in the amount of their own determination (ad libitum) using different sized (23 cm and 31 cm) plates. The size of the plates that individuals will use on different experimental days was determined randomly.

Eligibility Criteria:
Inclusion Criteria:

* having a score of \<20 from EAT-26 test,
* not smoking,
* not following any diet,
* not having a diagnosis of any metabolic disease,
* not being color blind,
* not being a professional athlete,
* not using nutritional supplements,
* not having any food allergy,
* not being selective towards certain food.
* not being pregnant or lactating,
* not using any medication that affects appetite and body weight,
* not having the habit of consuming regular main meals.

Exclusion criteria: Failing to meet the inclusion criteria
Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult population.


Eligibility Criteria:
Inclusion Criteria:

* Being under investigation for pituitary- adrenal functions

Exclusion Criteria:

* Diabetes mellitus or any other chronic metabolic disease
* Taking medicine for any reason
* Anemia
* Polyctemia
* Compromised circulation
* Hypoxia
Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency department visits and are the most common musculoskeletal injury in the physically active population. Although the current accepted treatment of ankle sprains is to encourage early mobilization with functional rehabilitation, there is little high-quality evidence directing this clinical practice.

This pilot study is to:

* provide quantitative data for estimation of mean outcome scores and standard deviations to allow subsequent sample size calculations
* evaluate the feasibility of the proposed study design
* assess patient enrollment issues specific to randomization into an active rehabilitation program compared to below knee immobilization.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)

Exclusion Criteria:

* bony injury on x-ray or computed tomography
* contraindications to recurrent icing
* high risk of deep-vein thrombosis
* injury greater than 3 days old
* ongoing recovery from previous acute ankle sprain
* age greater than 60
* non-English speaking patients, those patients unable to provide informed consent or patients with insufficient contact information for follow-up
Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms

The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these TIA patients, thus making screening of these patients (for AAA) more cost-efficient.

Study will be carried out as a prospective screening study. Data will be collected in North Karelia Central Hospital within one year. All male patients with TIA symptoms will be recruited for the study and screened for AAA with ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* male patient who has had symptoms of transient ischemic attack (TIA)

Exclusion Criteria:

* Patient's denial to participate
* Female gender
* Already diagnosed or treated abdominal aortic aneurysm
Oral Administration of Peptides; Absorption From Gastrointestinal Tract

Context: Oral formulations of GLP-1 and PYY3-36, two satiety peptides, were studied. An oral delivery system would be preferable in many of the possible therapeutic indications of these peptides.

Objectives: Our objective was to establish the pharmacological profile of increasing oral doses of GLP-1 and PYY3-36 in healthy volunteers. In addition, the pharmacological effects of GLP-1 were investigated.

Setting: Single center escalating dose study with oral applications. Subjects and Methods: In the first part, GLP-1 was given orally to 6 male subjects; the treatment consisted of one of the following oral doses of either GLP-1 (0.5, 1.0, 2.0 and 4.0 mg) or placebo. In the second part, PYY3-36 was given orally to another 6 healthy male subjects; the treatment consisted of one of the following oral doses of either PYY3-36 (0.25, 0.5, 1.0, 2.0 and 4.0 mg) or placebo.

The study was conducted as a phase I, open, placebo-controlled, dose-escalating study. In part I, six treatments, separated by at least 7 days, were performed in 6 male subjects; treatments consisted of one oral dose of GLP-1(7-36 amide) (0.5, 1.0, 2.0, and 4 mg) or placebo; the last treatment was an intravenous infusion of GLP-1 given for 45 min (0.4 pmol/kg per min infused for 45 min). The treatments were identical in design except for the oral dose of GLP-1. In part II, six oral treatments, separated by at least 7 days, were given in an additional 6 male subjects; treatments consisted of one oral dose of PYY3-36 (0.25, 0.5, 1.0, 2.0, and 4 mg) or placebo; an intravenous infusion of PYY3-36 could not be given as no GMP conform PYY3-36 was available for use in humans. Blood was drawn in regular intervals in EDTA tubes containing aprotinin (500 kIU/ml blood) and a DPP-IV inhibitor for hormone determinations: -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300 min.

Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* females
REP1 Gene Replacement Therapy for Choroideremia

The assessment of the efficacy (with respect to preservation of visual function and retinal structure) and safety of a single subretinal injection of AAV2.REP1 in participants with a confirmed diagnosis of choroideremia, as evaluated by various functional and anatomical outcomes measured over a number of time points up to 24 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Candidate is willing and able to give informed consent for participation in the study.
2. Male aged 18 years or above.
3. Genetic or molecular confirmed diagnosis of choroideremia (REP1 protein deficiency).
4. Active disease visible clinically within the macula region.
5. Best corrected visual acuity better than or equal to 6/60 (20/200; Decimal 0.1; LogMAR 1.0) in the study eye.

Exclusion Criteria:

1. Any female, or a male aged below 18 years.
2. An additional cause for sight loss (e.g. amblyopia) in the eye to be treated.
3. Any other significant ocular and non-ocular disease or disorder which, in the opinion of the investigator, may put the participants at risk because of participation in the study.
4. Inability to take systemic prednisolone for a period of 45 days.
5. Unwillingness to use barrier contraception methods for a period of three months following gene therapy surgery.
6. Participation in another research study involving an investigational product in the preceding 12 weeks.
The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation

The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.

Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 14 years of age until 55 years of age
* Individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Those who are unwilling to discontinue hydroquinone, vitamin A/C/E, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study.
* Subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Evaluation of Post-Angioplasty Outcomes

There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be conservative or aggressive.

Angioplasty can help restore blood flow and long-term patency of the blood vessels can help prevent major surgeries, such as amputation which affects patient's quality of life. However, some of these patients do not benefit from angioplasty and eventually had to undergo amputation. On the other hand, there are patients that undergo amputation, but may stand to benefit from angioplasty. Hence, it is essential to identify patients that will likely benefit from angioplasty to increase limb salvage rate. Many studies performed have also concluded that before amputations are performed, surgeons should consider angioplasty procedures.

Through a medical record review of patients that have undergone angioplasty to evaluate post-angioplasty outcomes, we hope to identify factors that potentially affects these outcomes. Ultimately with a better understanding of these factors and their impact on angioplasty outcomes, a predictive model or guideline can be developed to identify patients that stands to benefit from angioplasty. Such a model can help clinicians to better counsel patients on the risk and benefits, alternatives and prognosis. Patients can also make a better informed decision regarding their treatment


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted into SGH Department of Vascular Surgery, and have successfully undergone angioplasty

Exclusion Criteria:

* Minors under age of 21
Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

The purpose of this study is to identify the characteristics of the disease, diagnose the disease by computer and evaluate the rehabilitation based on gait touch information after ACL rupture and reconstruction, combined with the methods of multi-body dynamics, machine learning and biomechanics analysis. Methods: 55 healthy volunteers, 55 patients with ACL rupture were recruited. Three dimensional gait analysis and dynamic plantar pressure were used to test the kinematic and dynamic data of lower limbs and gait touch information when walking, jogging, stopping and jumping, and running side cutting.

Outcome evaluation indexes and statistical methods:

the following indexes were measured repeatedly by two factor ANOVA method, and the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of gait touch information were analyzed. To study the biomechanical status of different knee joints and the mechanism of the change of gait touch information. Finally, based on the information of gait touch, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying and evaluating the biomechanical state of knee joint under the dynamic load-bearing state of gait touch information.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
* With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
* All participants have no known disorders or diseases other than ACL rupture.

Exclusion Criteria:

* Cognitive impairment
* Other injuries affecting movement performance.
Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.

This is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the treatment of travelers' diarrhea. After 3 unformed stools are recorded within the 24 hours immediately preceding randomization, participants are to be randomized to receive the generic rifaximin 200 mg oral tablet, Xifaxan (the reference listed drug)200 mg oral tablet, or placebo 3 times daily for 3 days (that is; on Days 1, 2, and 3).

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.
2. At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.
3. At least 1 of the following signs and symptoms of enteric infection:

   * abdominal pain or cramps
   * nausea
   * vomiting
   * fecal urgency
   * excessive gas/flatulence
   * tenesmus
4. Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.

Exclusion Criteria:

1. Pregnant, breast feeding, or planning a pregnancy.
2. Immediately prior to randomization, acute diarrhea for \>72 hours.
3. Presence of:

   * fever (≥100 degrees fahrenheit \[°F\] or ≥37.8 degrees celsius \[°C\]), or
   * hematochezia (blood in stool), or
   * clinical findings suggesting moderate or severe dehydration.
4. Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.
5. Administration of any of the following:

   * any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
   * more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization
6. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.
A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.

The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 18 to 55 years on screening

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness

The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.

The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.

The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.

Eligibility Criteria:
Inclusion Criteria:

* Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
* Age greater than or equal to 18 years.
* Life expectancy greater than or equal to 2 months.
* ECOG performance status 0 - 2.
* Adequate organ function and bone marrow reserve.
* Use of appropriate contraceptive method.
* Sign patient informed consent.

Exclusion Criteria:

* Active brain metastases.
* Presence of third-space fluid collections (pleural effusion, ascites).
* Major surgery within 3 weeks prior to dosing.
* Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
* Prior bone marrow transplantation.
* Presence of uncontrolled serious medical or psychiatric illness.
* Patients requiring radiation therapy.

There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.