cyrilzakka/clinical-trials huggingface dataset:
ACP-104 in Acutely Psychotic Subjects With Schizophrenia

This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; 18-60 years of age
* The subject is physically healthy and medically stable.
* The subject is able to provide informed consent
* The subject has been diagnosed with schizophrenia for at least 1 year
* Currently experiencing an acute episode of psychosis
* The subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks.
* The subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits.
* If the subject is female, subject must be of non-childbearing potential - OR- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol.

Exclusion Criteria:

* If the subject is a pregnant or lactating (breast-feeding) female.
* The subject has a significant risk of suicide, homicide, and/or harm to self or others.
* Subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years.
* The subject is experiencing his/her first episode of schizophrenia.
* The subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation).
* The subject has been prescribed or exposed to clozapine before.
* The subject has donated blood or plasma within 56 days prior to the Screening Visit.
* The subject has participated in any clinical study within 30 days prior to the Screening Visit.

In addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).
Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus

forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
* Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
* Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
* Dose not receive the topical chemical peeling within 4 weeks before entered the study
* Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
* Can follow the study's protocol

Exclusion Criteria:

* Pregnancy or lactation
* History of skin cancer
* History of photo allergy
* History of bleeding tendency
* History of abnormal wound healing
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
* Male and Female over 12 years or greater

Exclusion Criteria:

* Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
* Previous history of zygomycosis
* Anticipated survival less than one month
Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia

This study is designed to compare the efficacy and drug tolerability of two strategies for the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with schizophrenia.

There is agreement in the psychiatry community that the so-called atypical antipsychotics should be considered first choice in the treatment of schizophrenic disorders. However, the general superiority of these newer antipsychotic drugs over the older conventional drugs could not be clearly demonstrated in recent controlled clinical trials. The discrepancy between every day's clinical perception and the results of clinical trials raises the question whether the studies performed so far employed the adequate methodological approach to represent the daily practice situation which is characterized by a wide variety of duration and type of the schizophrenic disorder, concomitant diseases, and medications. Moreover, some studies might not have been focused adequately on patient-relevant outcome variables.

The present study project is designed to answer these open questions. The innovative character of the study design is

1. that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using
2. an enhanced biometric design, that provides a choice of treatment with respect to the individual patient though the trial as such is randomised controlled and double blind;
3. that clinically relevant endpoints such as quality of life will be the primary variables, and
4. inclusion and exclusion criteria lead to a study population representing clinical every day practice as near as possible.

Another innovatory procedure is that serum levels of the study drugs will be recorded twice during the study. The authors hope that their design might yield transfer effects for other clinical trials facing similar problems.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* age 18-65 years
* necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects
* written informed consent

Exclusion Criteria (amongst others):

* Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol
* Acute suicidal tendency
* "Einwilligungsvorbehalt (BGB)" or "Unterbringung (PsychKG)"
* Epilepsy
* Organic psychosis
* Parkinson Disease
* Dementia
* History of malignant neuroleptic syndrome
* QTc interval ≥ 0.5s / history of congenital QTc prolongation
PSP as Indicator for Urinary Sepsis in ICU

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. pancreatic stone protein has been studied as biomarker of sepsis and results suggests that it has higher diagnostic performance. The main objective of this study is to identify ability of pancreatic stone protein (PSP) as a new biomarker for diagnosis of urosepsis in Intensive Care Units comparison to other biomarkers and its role as a prognostic marker for mortality


Eligibility Criteria:
Inclusion Criteria:

* Adult ill patients at the ICU aged more than 18 years old who at risk of urosepsis.
* Both males and females.

Exclusion Criteria:

* - Age less than 18 years.
* Patients with a clinical diagnosis of sepsis at admission.
* Critically ill septic patients with a diagnosis other than urosepsis.
* Critically ill patients who were diagnosed to have urosepsis outside Ain Shams university intensive care and transferred to it.
* Malignant tumor patients.
* Uremic patients undergoing dialysis.
Assessment of Thrombogenicity in Acute Coronary Syndrome

The purpose of this study is to assess platelet dependent thrombogenicity in patients after acute coronary syndrome using an ex vivo arterial injury model.

Abnormal platelet activity seen in patients with Type2 Diabetes Mellitus (T2DM) may be an important contributor to their enhanced cardiovascular risk and higher rates of cardiovascular events following acute coronary syndrome, despite dual antiplatelet therapy with aspirin and clopidogrel. We have earlier demonstrated high thrombogenicity in individuals with T2DM and CAD in the absence of acute ischaemic events, despite therapeutic doses of aspirin.We hypothesise that patients with T2DM will have increased thrombogenicity after acute coronary syndrome despite optimal secondary prevention medication.Measuring ex vivo thrombus area using an arterial injury model simulates plaque rupture and reflects the summative effect of all haemostatic abnormalities. The thrombus area of patients with ACS and T2DM will be compared to the controls without T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome (WHO criteria) with raised cardiac troponin T
* Aged 18-80 years
* Stable Acute coronary syndrome
* On aspirin and clopidogrel
* Willing to participate in the study

Exclusion Criteria:

* Smoking (current smokers or smokers who quit in the last 6 months preceding recruitment)
* Malignancy (any suspected or proven)
* Haematological disorders (bleeding disorders)
* Pre-menopausal women
* Use of corticosteroids/other antithrombotic agents (warfarin)
* Chronic liver disease
* Unable to consent
Quit4Baby Evaluation

The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Eligibility Criteria:
Inclusion Criteria:

1. Subscribe to the text4baby test messaging program
2. Pregnant
3. Smoke or recently quit (within last 2 weeks)- Smoking will be defined as self-report of smoking at least one cigarette in the past 7 days. Given that these individuals are recruited from text4baby users, we are confident that they will have cell phones and text messaging capacity.
4. Speak English
5. Willing to enroll in our study
6. 14 years old or older

Exclusion Criteria:

1. No longer subscribe to text4baby
2. Not pregnant
3. Not current smoker (within past 2 weeks)
4. Non-English speakers
5. Not willing to receive Quit4Baby messages or enroll in study
6. Younger than 14 years of age
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Eligibility Criteria:
Key Inclusion Criteria:

* Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
* Has constipation that is caused by the chronic use of opioids
* Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

* Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction
* Has evidence of intestinal obstruction
* Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
* Has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
* Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
* Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
Effects of a Computerized Physician Order Entry (CPOE)-Based Inpatient Insulin Protocol on Glycemic Outcomes

Retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes

This study is a retrospective cross-sectional study at one institution, where the investigators compared diabetic patients admitted to Medicine Services from March-April 2006 (before CPOE was implemented) to patients admitted from October-November 2007 (one year after CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication profile and demographic data were obtained to compare between groups. The investigators hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing, improves outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Diabetes Mellitus

Exclusion Criteria:

* Admitted to Non-Medicine Hospital Services
Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo

The goal of this clinical trial is to assess the efficacy and safety of a combination of aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine and cyanocobalamin as adjuvant therapy for vertigo comparatively to ginger under a double-blind randomized study design.

Motion sickness is a chronic condition characterized by vestibular changes in response to stimuli caused either by movement or movement perception triggered by car, train, ship or aircraft transportation, amusement park rides, virtual reality and simulators, walking, exercising, as well as under the absence of gravity in space.The studied combination drug is composed by GABA (gamma-aminobutyric acid), the main inhibitory neurotransmitter of the central nervous system. The former lowers anxiety symptoms. Its precursor, glutamic acid, is the amino acid found in greater concentration under free form in the CNS; it is closely related to brain metabolism and, in contrast to GABA, it is the main excitatory neurotransmitter; glutamic acid also has anxyolytic therapeutic properties. Thiamine or vitamin B1 is a cofactor in the synthesis of acetylcholine, which plays a central role in the initiation and propagation of neural impulse in the CNS as well as it does in the skeletal and myocardial muscles. Pyridoxine or vitamin B6 plays a role in the synthesis of neurotransmitters such as dopamine as well as in the metabolism of tryptophan, resulting in an increase in serotonin so providing well-being and anxiety relief. Pyridoxine is essential for the proper functioning of the CNS (including at nausea and vomiting center). Cyancobalamin or Vitamin B12 plays a role in the growth and repair of nerve fibers. Importantly it also improves blood flow in the brain, with secondary vertigo improvement. The combined use of these substances provides relief of vertigo due to motion sickness. Zingiber officinale is a species of the Zingiberacaea family, widely used in traditional and herbal medicine for the treatment of various clinical conditions such as vertigo.

Eligibility Criteria:
Inclusion Criteria:

* clinical kinetosis
* female study subjects must agree in using contraceptives during study period
* dated informed consent read, understood and undersigned

Exclusion Criteria:

* hypersensitivity to the drugs of the study
* history of gallblader stones
* history of gastric mucosa inflammation
* arterial blood pressure \>145/100 mmHg
* use of medication for kinetosis other than the study drugs
Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients.

The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures.

In this paper the investigators report an original research evaluating the accuracy of computer-guided implant placement in posterior edentulous mandibular spaces. In this randomized controlled trial, several factors were evaluated such as primary implant stability, possibility of immediate loading, displacement at crestal and apical levels, angle of deviation, surgical guide design, computer-aided design and computer-aided manufacturing accuracy, and variance between different implant macro-geometries and lengths. As exhaustive description of the assessment techniques as well as the statistic results were also presented in this article.

Nowadays, the use of guided surgery is vastly increasing in a daily dental practice. In the "Era of Digital Dentistry", it is of utmost importance to evaluate the accuracy and precision of the computer-guided techniques in order to determine their limits, avoid risks (adjacent anatomical structures, limited crestal volume, immediate loading), and apply them in safe manner. Evidence-based scientific data on this matter is still deficient. In these terms, the investigators consider it very interesting and of high clinical value for all oral surgeons and dental practitioners to evaluate in a clinical research the precision and distortion of computer-guided implant surgery.

Eligibility Criteria:
Inclusion Criteria:

* Acceptable oral hygiene with no signs of active periodontal disease or local infection
* American Society of Anesthesiologists (ASA) physical status classification 1 and 2
* Non or Light smoking (\< 10 cigarettes per day)
* Acceptable intermaxillary space (44 mm minimum)
* Minimal crestal width of 5.5mm
* Minimal residual bone height of 10mm above the alveolar nerve canal

Exclusion Criteria:

* Head and neck irradiation
* Bone grafted sites
* Severe bruxism
* Cone Beam Computed tomography with exaggerated artifacts
* Limited intermaxillary space
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.


Eligibility Criteria:
Inclusion Criteria:

* Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:

  1. Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
  2. Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
* Informed consent by patients/parents or other legal representatives

Exclusion Criteria:

* Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
* Coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN and / or at the Investigator's discretion
* Previous enrolment of the patient into the current study
* Participation of the patient in another study within 30 days preceding and during the present study
* Patients or parents/other legal representatives expected not to comply with the study protocol
* Suspicion of child abuse
* Pregnant or breast feeding females
* Contamination derived from biopsy which could interfere with patients health
* Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
* Skin substitute has not been released due to production specific deviations
* Patients allergic to amphotericin B and gentamicin