cyrilzakka/clinical-trials huggingface dataset:
Adapting Dialectical Behavior Therapy for Children in Residential Care

I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition).

II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.

Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment attendance, treatment satisfaction, and any differences in these rates by groups.

Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.

Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and externalizing symptoms.

Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer internalizing and externalizing symptoms.

Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation, risk taking, and social skills, and reducing depression.

Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly greater improvement in adaptive coping skills, emotion regulation, risk taking and impulsivity and social skills, and reducing depressive symptoms.

Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.

Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer critical incidents, including psychiatric hospitalization, emergency room visits, total number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting out, running away, stealing, police involvement, etc.

Eligibility Criteria:
Inclusion Criteria:

* age between 6 years 0 months and 12 years 11 months;
* male;
* in residential care at Green Chimneys;
* projected length of stay is at least 8 months.

Exclusion Criteria:

* pervasive developmental disorder;
* psychotic disorder;
* mental retardation; (all as per psychiatric evaluation at Green Chimneys);
* in care or custody of the Department of Social Services (DSS);
* caregivers do not speak English.
A Strength-Based Employment Maintenance Program for Individuals on the Autism Spectrum

The investigators are looking to evaluate how effective a training program that focuses on character strengths may be in improving job maintenance skills in young adults. The investigators are examining the effects of this intervention in young adults who feel they would like to help in improving their satisfaction with work, and in keeping their jobs.

Individuals with autism possess employable and valuable strengths and abilities. Unfortunately, despite these strengths, individuals with autism experience challenges in obtaining and maintaining employment. Traditionally, the majority of interventions designed for autism (including those focused on employment) focus on remediating deficits, without harnessing the strengths of those with autism. This deficit-based approach (i.e. to fix what is deficient in a person with autism) has triggered increasing criticism and dissatisfaction from the autism community. A growing shift toward strength-based training tools represent a holistic approach to treatment of autistic individuals by acknowledging and using their strengths to improve outcomes. To date, no strength-based employment programs have been examined in individuals with autism. Thus, in the current project, the investigators aim to develop and test a strength-based employment program. At Kessler Foundation, the investigators have developed a strength-based training tool: Kessler Foundation Strength Identification and Expression (KF-STRIDE®) which targets job interview skills by teaching individuals with autism to identify and express their personal strengths to a future employer. In the current proposal, the investigators aim to adapt this program to specifically target job maintenance skills.

Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States of America
* Between the ages of 14-26
* Speaks English well and at a 4th grade reading level

Exclusion Criteria:

* Had a stroke, Traumatic Brain Injury, or neurological injury or disease in the past(like brain tumor or epilepsy)
* Has a history of significant psychiatric illness(like schizophrenia or psychosis)
* Has uncontrolled seizures or other unstable medical complications
Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.

Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.


Eligibility Criteria:
Inclusion Criteria:

* Systemic autoimmune diseases
* Healthy individuals - as controls

Exclusion Criteria:

* Diseases of the central nervous system
* Presence of pregnancy
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)

A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized comparative study.

This study is a prospective, multi-centered, randomized, comparative study designed to demonstrate substantially equivalence performance of the proposed device, the PulmOne MiniBoxPFT, to its predicate device, the ZAN500, for the measurement of total lung capacity (TLC).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject is cooperative and capable of following instructions.
3. Healthy subjects:

   1. Never smokers.
   2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
   3. BMI \< 35.
   4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm).
   5. No history suggesting upper respiratory infection during the three weeks prior to testing.
4. Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.

Exclusion Criteria:

1. Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia).
2. Subjects unable or unwilling to give informed consent.
3. Subjects who have performed any significant physical activity during 1 hour prior to the Study.
4. Patients with a tracheostomy.
5. Pregnant women.
Alternate-Day Buprenorphine Administration. Phase VIII - 9

The purpose of this study is to evaluate open buprenorphine dosing with dose choice.


Eligibility Criteria:
Please contact site for information.
Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment.

However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.

Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
* PCOS diagnosis.
* Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.

Exclusion Criteria:

* Another diseases with androgen excess;
* Patients with history of serious adverse reaction or hypersensibility to any medicine;
* History or presence of renal, hepatic or gastrointestinal disorders.
* Continuous use of any pharmaco, inclusively metformin
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial

Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.

The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Lidocaine allergy
* Pregnancy
* Previous uterine or cervical surgical procedures
* Neurological abnormalities
* Coagulopathy
* Infection of cervix, vagina, or pelvic cavity
* Taking any analgesic drugs within 4 hours before the procedure
Early Rabies Vaccine Immunization in Primary School Children

700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.


Eligibility Criteria:
Inclusion criteria:

Male and female 5-8 years old school children will be included in the study if:

* Their parents or legal guardians have given the written informed consent prior to study entry;
* They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator;
* They are available for all the visits scheduled in the study.

Exclusion criteria:

Subjects are not to be enrolled into the study if:

* They have a history of rabies immunization;
* They have an acute infectious disease at the time of study entry;
* They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment;
* They have a known immunodeficiency or an autoimmune disease;
* They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B;
* They have planned surgery during the first study period (49 days);
* They are participating in any other trial of an investigational agent;
* They have any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* The family plans to leave the area of the study site before the end of the study period.
Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

interventional randomized clinical trial will be done at Assuit University Hospital ( Chest Department and Caridothoracic surgery department ),and all patients presented with complex septate pleural effusion in whom the symptoms excepted to be relieved by pleural fluid drainage will be included in our study within the two next years.

The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. Despite the improvement in the management options of pleural effusion; intrapleural adhesions remain a significant problem in many patients with pleural disease. The presence of adhesions carry a poor prognostic factor in patients with exudative pleural effusions that it may render the drainage of pleural fluid difficulty inspite of tube being patent and correctly positioned.

Two options are currently available to deal with the problem of pleural adhesions, the first is chemical and the second is mechanical adhesiolysis . Chemical adhesiolysis means lysis of the adhesive bands medically by instillation intrapleural chemical agents e.g. streptokinase, urokinase, tissue plasminogen activator, streptodornase, deoxyribonuclease (human recombinant \[hr\]DNAase), single-chain urokinase plasminogen activator and the uncommonly used MESNA (2-mercaptoethane sulfonate Na) . Mechanical adhesiolysis means breaking up the adhesive bands and removing it by pulling and dissecting via medical thoracoscope, minimally invasive video assisted thoracoscopy (VATS) or more invasive thoracotomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic pleural effusion in whom the symptoms excepted to be relieved by pleural fluid drainage.
* Presence of intrapleural adhesions as documented sonographically.
* Difficult thoracentesis.
* Failure of satisfactory pleural fluid drainage 24 hours following intercostal tube (ICT) placement provided that the tube was properly positioned and not obstructed.
* Written consent, free and informed.

Exclusion Criteria: patients have contraindications for any of our procedures will be excluded.

* Contraindications for streptokinase instillation i.e. (Previous allergic reaction, bronchopleural fistula, trauma or surgery within 48 hrs, history of hemorrhagic stroke, coagulation defects and previous streptokinase thrombolysis).
* Patients who are unfit for general anaesthesia.
Botox Injections for Patients With Persistent Facial Pain

The main objective of this study is to investigate efficacy and safety of injecting botulinum toxin towards the sphenopalatine ganglion using MultiGuide in patients with persistent idiopathic facial pain


Eligibility Criteria:
Inclusion Criteria:

* Persistent Idiopathic Facial Pain fulfilling diagnostic criteria as classified in The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version) as modified by the authors of this trial. See below.
* Unsatisfactory effect of available treatment methods as evaluated by a neurologist, ENT specialist or maxillofacial surgeon. The patient should have failed treatment with both anticonvulsant as carbamazepine (Tegretol, Carbatrol) and antidepressant as tricyclic antidepressants
* Average Pain intensity ≥4 (0-10) in Numeric Pain Rating Scale (NRS) on the affected side during the 4-week baseline period
* Written informed consent from the patient

Modified diagnostic criteria for PIFP according to The International

Classification of Headache Disorders, 3rd edition (ICHD-3 beta version):

A. Facial and/or oral pain fulfilling criteria B and C.

B. Recurring daily for \>2 hr per day for \>3 months

C. Pain has both of the following characteristics:

1. Poorly localized and may radiate beyond the trigeminal nerve distribution
2. Dull, aching or nagging quality D. Clinical neurological examination is normal, however patient may denote paresthesia E. A dental cause has been excluded by appropriate investigations; signs of structural pathology or other specific causes of pain are not identified. Minor operation and injury (insignificant trauma e.g. tooth extraction) to the face, maxilla, teeth and gums without a direct causal relationship with the pain regarding both time and site is accepted. F. Not better accounted for by another ICHD-3 diagnosis.

Exclusion Criteria:

* Bilateral symmetrically affected
* Neurological disorders or other related systemic diseases that can explain the pain
* MRI/CT examination confirming intracranial pathology.
* Systemic or local disease or condition that can give a significantly increased risk of complications to the particular procedure
* Not competent to asses informed consent based on neurological assessment
* Psychiatric disorder that prevents the completion of the study
* Pregnancy
* Inappropriate use of contraception
* Breastfeeding
* Abuse or unauthorized use of medication, drugs or alcohol
* Allergy or other hypersensitivity reactions to marcaine, lidocaine, xylocaine, or adrenaline, possibly similar related drugs
* Anatomical factors that prevent or impede the injection
* Known hypersensitivity to botulinum toxin type A or to any of the excipients
* Treatment with drugs that can interact with botulinum toxin type A: aminoglycoside antibiotics, spectinomycin, neuromuscular blockers, both depolarizing (succinylcholine) and non-depolarizing (tubocurarine derivatives), lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases.
Impact of Repeatedly-Administered THC-cannabis on Experimental Pain and Abuse Liability in Humans

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. However, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. Carefully controlled research is needed.

The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep?

Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.


Eligibility Criteria:
Inclusion Criteria:

* Males/non-pregnant females, 21-60 years old
* Current cannabis user
* Able to perform all study procedures

Exclusion Criteria:

* Use of other illicit drugs
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
* Insensitivity to the cold-water stimulus of the Cold Pressor Test or the heat stimulus of Quantitative Sensory Testing
Impaired Peripheral Endothelial Function and In-stent Restenosis

The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).

This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.

Exclusion Criteria:

* Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement

The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.


Eligibility Criteria:
Inclusion Criteria:

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve

1. Considered at increased surgical risk by the Multidisciplinary Heart Team
2. Informed written consent

Exclusion Criteria:

1. Non-cardiovascular co-morbidity reducing life expectancy to \<3 years
2. Any factor precluding 1 year follow-up
3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
4. Predicted inability to perform uncomplicated percutaneous vascular access and closure
5. Illiofemoral diameter \<6 mm (for 23 and 25 mm valves) and \<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
6. Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure
7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
8. Language barriers (inability to understand peri-procedural and discharge instructions)
9. Insufficient social support post procedure to allow next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anaesthetic