cyrilzakka/clinical-trials huggingface dataset:
Substance Use Interventions for Truant Adolescents

This study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.

Adolescents who use marijuana and are truant from school are a high-risk population with increased likelihood of substance use disorders, criminal justice involvement, and long-term impairments in vocational, family, and peer domains.

This study will test a theory-driven intervention for early adolescent marijuana using, truant youth identified through Rhode Island Truancy and Family Courts. Adolescents will be randomly assigned to one of the 2 conditions: a motivational interview versus psychoeducation.

Eligibility Criteria:
Inclusion Criteria:

* the target child is in 6th-10th grade at the start of the project and living at home with at least one parent/guardian,
* the teen must report 6 or more incidences of marijuana use in the last 90 days (an approximation of biweekly use)
* by law, the teen must have at least 20 unexcused absences in an academic year to be in truancy court, and (4) parental consent and teen assent are obtained.

Exclusion Criteria:

* the family is not able to speak and understand English or Spanish well enough to complete study procedures
* developmental delay, as determined by school placements outside the regular classroom, that would affect comprehension of the intervention.
Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique

The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-10 years old
* Mentally capable of communication
* Cooperative children need restorative treatment

Exclusion Criteria:

* Medically compromised patient
* Primary teeth requiring pulpotomy or pulpectomy
* Parent or guardians who refuse participating in the study
Immunomodulatory Effects of Dexmedetomidine Infusion

Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective laparoscopic major abdominal surgeries;
* ASA class II-III

Exclusion Criteria:

- 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.

6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation
Diet and Activity in Cerebral Palsy

This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy

Exclusion Criteria:

* Concurrent severe neurologic or other medical diagnosis that is likely to be contributing to the subject's functional impairment, as determined by the study investigators. For example, associated spinal cord injury.
* Subjects with major limb amputations
* Pregnant or lactating females
Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial

This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming using a forced air body warming, control group received no active warming system. Both groups were then warmed with forced air warmer intraoperatively.

Inadvertent perioperative hypothermia is a well known perioperative complication. The behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. Anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. Inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. It is defined as a core temperature below 36°C (96.8°F). The aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* undergoing elective laparoscopic gynecological surgical procedures
* expected duration \>60 minutes
* BMI 18-45

Exclusion Criteria:

* Current fever (temperature\>38.1°C)
* active endocrine disorders were exclusion criteria
Lymphangioleiomyomatosis (LAM) Registry

To establish a registry of individuals with LAM by forming a consortium of six clinical centers and referring physicians who treat LAM patients.

BACKGROUND:

LAM is a rare multi-system disease that can affect the lungs of young women, is of uncertain cause, is usually progressive, and can cause debilitating lung disease which may be corrected with lung transplantation. Several hundred women with the disease have been identified, largely through a LAM Foundation in Cincinnati, Ohio.

DESIGN NARRATIVE:

The Data and Coordinating Center is located at the Cleveland Clinic Foundation. The registry has six major clinical centers: Cleveland Clinic Foundation, Mayo Clinic-Rochester, National Heart, Lung, and Blood Institute, National Jewish Medical and Research Center, New England Medical Center, and Stanford University Medical Center. Data and lung tissue collected by the registry will be used to characterize the clinical features and natural history of the disease and to determine the efficacy of lung transplantation in this disorder. Eligible patients are to be seen yearly for up to 4 years at the Clinical Centers or, in some cases, by individual referring physicians. Tissue collected by the LAM Registry will be stored at a central NHLBI repository. Outcome events include measures of pulmonary function (eg, spirometry and, when available, lung volumes and diffusing capacity), arterial blood gases or oximetry, walking and resting oxygen titration, cardiopulmonary stress testing, cause-specific mortality, functional status, and clinical events associated with lung transplantation.

The Office of Research on Women's Health provided funding in FY 1997 in the amount of $100,000.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms

Based on a prospectively collected data analysis, a new tool, namely CoMDA (Cognition in Movement Disorders Assessment) is developed by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). A machine learning, able to classify the cognitive profile and predict patients' at risk of dementia, is created.

A prospectively data-base was setting up, collecting CoMDA and in-depht-neuropsychologocal-battery scores, obtained from the evaluation of 500 patients with parkinsonisms. Data were analyzed to compare the classification of patient cognition profile, obtained with CoMDA, MMSE, MoC and FAB, with that obtained from in-depth neuropsychological evaluation. A very high percentage of false negative emerged, for MMSE, MoCA and FAB. Conversely, the CoMDA score significantly reduces the rate of false negative.

This new tool, namely "CoMDA" (Cognition in Movement Disorders Assessment), was composed, by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). Moreover, we created a machine learning, namely "Neural Net 91classification" able to classify the cognitive profile and predict patients' at risk of dementia, providing a prediction of the findings resulting from a in-depht neuropsychological evaluation.

CoMDA and the related Neural Net 91classification represent a reliable, time-sparing screening instrument, which is much more powerful of other common, widely-adopted tools.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria (Postuma et al. 2015); b) diagnosis of PSP according to the MDS clinical diagnostic criteria (Höglinger et al. 2017); c) diagnosis of MSA according to the second diagnostic consensus statement (Gilman et al. 2008); d) diagnosis of VP according to Zijlmans et al (Zijlmans et al. 2004).

Exclusion Criteria:

a) any focal brain lesion detected with brain imaging studies (CT or MRI); b) diagnosis of clinically relevant psychiatric disorders, psychosis (evaluated with Neuropsychiatric Inventory) and/or delirium; c) diagnosis of dementia or MCI; d) diagnosis of neurological diseases other than PD or atypical parkinsonian syndromes; e) other medical conditions negatively affecting the cognitive status; f) disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III, such as to affect the psychometric evaluation; g) disturbing dyskinesia, corresponding to scores 2-4 in the specific items of MDS-UPDRS III, such as to affect the psychometric evaluation; h) auditory and/or visual dysfunctions impairing the patient´s ability to perform cognitive tests.
Cannabinoids, Learning, and Memory

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 and 55 years (extremes included) on day of first dosing
* Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

* Cannabis naive
* Positive pregnancy screen during screening
* Hearing deficits
Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-70 years old.
* patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
* patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
* pain scores between3 and 7 on visual analogue scale.
* patients sign the informed consent forms.

Exclusion Criteria:

* pregnant and lactating women.
* patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
* patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
* patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
* patients with severe pain resulted from diabetic and postherpetic neuralgia.
* patients who are allergic to the drugs used in this study.
* patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.
Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Male participants, with age greater than or equal to 18 years;
* Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period;
* Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors;
* Participants diagnosed with premature ejaculation;
* Participants with IELT ≤ 2 minutes;
* Participants with score ≥ 25 points in the erectile function questionnaire;
* Participants (or partners) who use at least one contraceptive method.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in a clinical trial in the year prior to this study;
* Known hypersensitivity to any of the formula compounds;
* Participants with cardiovascular disease for whom sexual activity is inadvisable
* History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation;
* Diagnosis of other diseases or conditions in the urinary tract;
* Participants with conditions that may predispose them to priapism;
* History of severe psychiatric or psychosocial disorders;
* Participant whose partner has clinically important sexual dysfunctions.
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.


Eligibility Criteria:
Inclusion Criteria:

* men and post-menopausal women
* LDL-C \> 4.1mmol/L at recruitment
* living within a 40 km radius of St. Michael's Hospital

Exclusion Criteria:

* lipid lowering medications
* clinical or biochemical evidence of diabetes, renal or hepatic disease
* body mass index (BMI) \>38 kg/m2
* antibiotic use within the last three months
* hormone replacement therapy
* smoking or significant alcohol use (\>1 drink/d)
* triglyceride level \> 4.0mmol/L
A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma

Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.

Rationale of induction chemotherapy:

Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC.

Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.

Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.

Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.

Objectives:

Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.

Study design:

This is a randomized, multi-center Phase III study. Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy.

Type and number of patients:

Patients with stage IVA (T4) and/or IVB (N3) but without distant metastasis will be enrolled. A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a two-sided logrank test with one interim analysis.

Treatment schedule:

Induction chemotherapy and CCRT:

Arm A: Weekly cisplatin concurrently with radiotherapy Arm B: Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy.

Study endpoints:

The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after +induction chemotherapy/CCRT, or death from any cause (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).( revised 8/27/2004)

Eligibility Criteria:
Inclusion Criteria:

* Histologically proved nasopharyngeal carcinoma.
* T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
* Eastern Cooperative Oncology Group performance status \< 2.
* A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
* A serum bilirubin level \< 1.5 mg/dL, serum creatinine level \< 1.6 mg/dL or creatinine clearance \> 60 mL/min.
* Age less than 70 years old
* An informed consent signed.

Exclusion Criteria:

* Evidence of metastatic disease.
* Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
* Presence of uncontrolled hypertension, poorly controlled heart failure.
* Presence of active infection.
* Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
* Women who test positive for pregnancy.
Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization

Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)

Exclusion Criteria:

* incomplete data during perioperative period
Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
* Aged more than 18 years
* Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
* the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
* Compliance with written informed consent

Exclusion Criteria:

* Atypical parkinsonian syndrome
* History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
* Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
* Presence of anatomical abnormalities in the target region
* Clinically significant medical history or that increases pre-/post-operative complications
* Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data