cyrilzakka/clinical-trials huggingface dataset:
Study of Hallucinations in Patients With Borderline Personality Disorder

Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.

The borderline personality disorder (BPD) is a very common personality disorder which concerns about 1.35% of total population. It is characterized by an affective, emotional, social and professional instability and an important association with comorbidities like mood disorders, post-traumatic stress disorder, addictive problems and suicide mortality. Hallucinations seem to be frequent in this personality disorder, but are not often taken in consideration by nursing staff because of massive need of attention of this kind of patient. At this moment there is no study of prevalence of this trouble in France in free environment. In the same way, there is no qualitative study about hallucinations. That is why we can do a lot of progress in this part of psychiatry.

This research is an observational study of descriptive type. Patients will be recruited in the different services. In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.

For that, the investigator will meet each patient twice, after information by the medical staff of the service and consent. During the first meeting, the investigator will get the socio-demographic characteristics, the verification of inclusion and non-inclusion criteria, and the DIB-R questionnaire to know if the patient has really BPD and hallucinations or not. This is the same interview for all patients. During the second meeting, we will look for dissociative symptoms with DES II questionnaire, then traumatic symptoms and post-traumatic stress disorder with THQ and PCL-S. The PSAS and qualitative questionnaire will be used for BPD patients with hallucinations.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and under 75
* Patient with borderline personality disorder (formerly or newly diagnosed diagnosis)
* Patient having given his opposition to his participation in research

Exclusion Criteria:

* Schizophrenia
* Major depressive episode characterized in progress
* Manic or hypomanic episode in progress
* History of head trauma
* Stroke, Parkinson's disease, dementia
* Autism
* Mental retardation
* Patient under the age of 75
* Patient who does not read or speak French
* Patient unable to give consent (includes protected persons: guardianship, trusteeship)
* Incarcerated patient
Pharmacokinetics of Anti-epileptic Drugs in Obese Children

The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid \[divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).


Eligibility Criteria:
Inclusion Criteria:

* 2 years to \< 18 years at the time of enrollment
* BMI ≥ 95th percentile for age and sex, based on CDC recommendations
* Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)
* Receiving ≥ 1 of the study drugs per local standard of care

Exclusion Criteria:

* Known pregnancy as determined via interview or test results, if available
Tobacco Approach Avoidance Training for Adolescent Smokers-1

This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias towards tobacco-related stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Between ages 13-18 years
* Able to read and write in English.
* Smokers: Smoking 5 or more cigarettes daily for at least 6 months; Baseline urine cotinine levels \> 500 ng/ml
* Nonsmokers: Never smokers; Baseline urine cotinine levels \< 50 ng/ml

Exclusion Criteria:

* Current criteria for dependence on another psychoactive substance
* Current diagnosis of psychosis, major depression or panic disorder
* Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable
* Pregnant or lactating girls, based on self report.
Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay

The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.

Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-70 years of age
* Must have received 23vPS pneumococcal vaccine

Exclusion Criteria:

* Bleeding diathesis
* Pregnancy
* Chronic disease which could be worsened by donating blood
* Receipt of blood, blood products or immune globulin within six months
Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Patients undergoing primary total hip arthroplasty
* Ambulatory patient prior to fracture
* Subjects must be capable of providing informed consent
* English or Spanish speaking

Exclusion Criteria:

* Previous hemiarthroplasty or THA on ipsilateral hip
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
* Acute or chronic hip infection in ipsilateral extremity
* Pregnant or breastfeeding
* Open fracture
* Polytrauma
* Intravenous or drug users within 6 months of surgery
* Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
* Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
* Severe renal dysfunctions, such as glomerular filtration rate less than 30
* Moderate to severe depression as diagnosed by a clinician
* Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
* History of uncontrolled narrow angle glaucoma
The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants

The objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment.

Research hypotheses include:1. The continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.The support program will also have positive effect on parent psychological well-being.

The objective of the study is to establish the continuous nurse-led integrated support program as well as exam its impact on neurodevelopmental health of preterm infants.

Research hypotheses:

1. Compared to control group, the preterm infants in the interventional group will experience significantly better performance on neuromotor, cognitive and social-emotional function at corrected age of 3 month;
2. In comparison with those receiving routine support, parents receiving nurse-led continuous support will have significantly higher parental self-efficacy and exhibited better psychological well-being;
3. Maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 28-36 weeks of gestation;
* Parents residing in the same region for at least 5 years; .Parents agree to participate in the study.

Exclusion Criteria:

* infants with severe perinatal brain injury;
* infant with congenital anomalies
Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Non smoker
* Normal lung function

Exclusion Criteria:

* Pulmonary, hepatic, or renal disease
* Congestive heart failure
* Active malignancy
* Systemic glucocorticoid therapy
Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.

The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.

Eligibility Criteria:
Inclusion Criteria:

* senile cataract with/without PEX

Exclusion Criteria:

* corneal pathology
* glaucoma,
* corneal astigmatism greater than 2.0 diopters (D),
* previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases),
* intraoperative complications,
* postoperative corrected distance visual acuity (CDVA) worse than 20/40,
* axial length below 21 mm and above 25 mm,
* dense cataracts or poor fixation requiring ultrasound biometry
* eyes with manifest iridophacodonesis and those in which a capsular tension ring was inserted
Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

The aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy. Medical records of 37 patients undergoing targeted disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index, Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain Questionnaire scales were used before treatment and 1,6,12 months after the procedure. North American Spine Society Satisfaction Scale was used at 12th month after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients having radicular pain with or without low back pain for at least 6 weeks inspite of conservative treatment who have unsequestrated, bulging, protruded or extruded hernia confirmed with MRI.

Exclusion Criteria:

* patients having a more than 50% loss in disc area, sequestrated disc, the presence of vertebra fracture or tumor, the patients having spinal stenosis or spondylolisthesis
Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.


Eligibility Criteria:
Inclusion Criteria:

* AML patients

  * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
  * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
  * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
  * Age ≥ 18 and ≤ 65 years
  * ECOG ≤ 2
  * HCT-CI ≤ 4 (51,52)
  * Absence of relevant psychiatric diseases
  * Signature of the informed consent

ALL patients

* Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
* Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
* Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
* Age ≥ 18 and ≤ 65 years
* ECOG ≤ 2
* HCT-CI ≤ 4
* Absence of relevant psychiatric diseases
* Signature of the informed consent

Exclusion Criteria:

* AML patients

  * AML in CR MRD-
  * AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
  * Age \< 18 years or \> 65 years
  * ECOG \> 2
  * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  * Pregnancy
  * No signature of the informed consent
* ALL patients

  * ALL with \> 5% peripheral blasts or bone marrow infiltration ≥30%
  * Philadelphia positive ALL
  * Age \< 18 years or \> 65 years
  * ECOG \> 2
  * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  * Pregnancy
  * No signature of the informed consent
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

This study is a long-term extension study of the protocol P00692 parent study.

Eligibility Criteria:
Inclusion Criteria:

* Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
* If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
* If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
* Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.

Exclusion Criteria:

* Has discontinued from the parent study (P00692) prior to study completion.
* Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
* Is a pregnant or lactating female.
* Is human immunodeficiency virus (HIV) positive.
Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.

The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.

This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.

Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.

Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of periodontitis stage III (grades A to C)
* on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment
* FMPS \< 20% at baseline
* Furcation not involved
* Not Pregnant or Lactating
* Signed informed consent

Exclusion Criteria:

* Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or any form of immunosuppression
* Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
* Chronic intake of NSAIDs or steroids, currently
A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).


Eligibility Criteria:
Inclusion Criteria:

* Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
* Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.

Exclusion Criteria:

* Active infection or dermatological condition at the treatment injection sites.
* History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.
Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents

The purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children.

In 2012 we studied 51 young footballers with Short Hamstring Syndrome in Spain. Three groups were formed:

1. Stretching+Transcutaneous Electrical Nervous Stimulation (TENS);
2. Active stretching;
3. Conventional stretching.

Parameters: straight leg raise test (SLR), popliteal angle with the passive knee extension test (PKE) and the toe-touch test (TT).

The inter-group means were compared and clinically relevant parameters calculated \[relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT)\].

Eligibility Criteria:
Inclusion Criteria:

* children between 10 to 16.
* children federated belonging to Football School of Jumilla.
* children whose result in the assessment of range of motion is less than 70º in the Straight Leg Raising Test.
* not afraid to present the application of electrotherapy.
* not have low back pain in last three months.
* not to be injured

Exclusion Criteria:

* children who have acute muscle injury or ligamentous.
* children with recent fractures or unconsolidated.
* children with ligamentous laxity.
* functional shortening suffering children
Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 \< 4 mg/ml)
* Male or female aged 18-65 years
* Informed Consent
* Ability to comply with the requirements of the protocol

Exclusion Criteria:

* Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
* Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
* The use of oral corticosteroids within the last 3 months
* Recent respiratory tract infection (2 months)
* Significant concomitant respiratory disease
* Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
* Any significant abnormal laboratory result as deemed by the investigators
* Pregnancy, planned pregnancy or lactation
* Known or suspected contra-indication to any of the IMP's
* Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial