cyrilzakka/clinical-trials huggingface dataset:
Identifying Characteristic Signature of Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment.

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment. All subjects will undergo 1-4 EEG sessions. In each session we will use a different dose of Ritalin or placebo. A detailed neuropsychological tests will be done during the EEG recording. A powerful machine-learning techniques will be used in order to find a specific signature of ADHD and Ritalin treatment in the EEG recording.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, aged 18-50 years.
* Subjects aged 18-50 years diagnosed with ADHD and treated with Ritalin regularly (at least once a week).

Exclusion Criteria:

* Patients previously diagnosed as suffering from a brain disease except for ADHD.
* Patients after traumatic head injury.
* Patients who are unable to express their consent to participate in the study.
Lithium Drug-Drug Interaction Study With Lurasidone HCl

The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.

To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
2. Females who participate in this study:

   * are unable to have children-OR-
   * are willing to remain abstinent from Day -5 until 90 days after discharge;
3. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

1. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
2. Positive test results within 30 days prior to the start of the study for:
3. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
4. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
5. Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
6. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea

This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.

In the surgical setting, patients with obstructive sleep apnea (OSA) may have increased upper airway collapsibility affecting ventilation and increased sensitivity to sedation from anesthetics and opioids.

Surgical patients with OSA have a high risk for postoperative complications, including cardiac events, hypoxemia, and transfer to the intensive care unit . Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate to severe OSA , and effectively reduces the risk of cardiovascular events. Evidence has shown that CPAP effectively reduces length of ICU stay (LOS) in the postoperative setting. In these scenarios, conventional oxygen therapy and high-flow nasal cannula (HFNC) therapy have been used as an alternative for CPAP non-adherent patients.

HFNC delivers warm, humidified air through a nasal cannula at high flow rates of up to 60 L/min. This high flow rate may increase end-expiratory pharyngeal pressure up to 3 cm H2O, decreasing the force required to alleviate airway collapse . Using a nasal cannula interface in contrast to the CPAP mask may provide a more comfortable experience for patients during sleep .

Eligibility Criteria:
Inclusion Criteria:

* Age group from 21 - 40 years old.
* Both sexes.
* Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than 5.
* OSA patients undergoing non cardiac surgeries.
* Patients who will undergo scheduled elective surgeries under general anesthesia.

Exclusion Criteria:

* Patient refusal of procedure or participation in the study.
* Patients with severe OSA, STOP-BANG score more than or equal 5.
* Patients dependent on home ventilation CPAP or bilevel devices.
* Pregnant females.
* Post cardiac or thoracic surgery patients.
* More than American Society of Anesthesiologists (ASA) II patients.
* Head and face trauma patients.
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',


Eligibility Criteria:
Inclusion Criteria:

* Acute Lymphocytic Leukemia
* Age 15 - 65 years

Exclusion Criteria:

* Serious secondary diseases which may compromise intensified chemotherapeutical treatment
* Serious psychiatric diseases, which may compromise compliance with therapy
* HIV-1 or HIV-2 Infection
* Pretreatment \> 2 weeks or chemotherapy other than Vincristine and Steroids
* Patients without central diagnosis who cannot be allocated to a risk group
Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-myeloid malignancy
* Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment
* Anemia predominately due to cancer or chemotherapy (Hb \>= 9.0 and \< 11.0 g/dL) at the time of screening
* 18 years of age or older at the time of screening
* Eastern Cooperative Oncology Group (ECOG) score 0-2
* Adequate liver and kidney function Exclusion Criteria:
* Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies
* History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma
* Serum folate \<= 2.0 ng/mL or vitamin B12 \<= 200 pg/mL at screening (anemia related to nutritional deficiencies)
* Iron deficiency \[transferrin saturation (TSAT) \< 15% and serum ferritin \< 10 ng/mL\] at screening
* Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia)
* Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn's disease)
* Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator
* Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia)
* Diastolic blood pressure \> 100 mmHg at screening
* Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients
* Known history of pure red cell aplasia
* Known positive antibody response to an ESP
* Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment
* ESP therapy (i.e., recombinant human erythropoietin \[rHuEPO\] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug
* RBC transfusion(s) within 21 days prior to screening
* Pregnant or breast-feeding women - Previously enrolled in this study
* Known to be HIV, hepatitis B or C positive
* Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures
Ligament Reconstruction in an Accelerated Rehabilitation Protocol

The investigators have found that their patients who get earlier rehabilitation following ligament reconstruction and tendon interposition (LRTI) surgery with interference screws have experienced better outcomes. The investigators hypothesis is that when formally comparing these patients who are exposed to the rehabilitation protocol earlier compared to later, the investigators will see statistically better outcomes.

Osteoarthritis (OA) of the 1st carpometacarpal (CMC) joint is a significant cause of hand pain, dysfunction, disability, and visible deformity. Surgery in the form of ligament reconstruction and tendon interposition (LRTI)is often indicated when less invasive procedures fail. Following LRTI procedures, the accepted classic protocol throughout the literature has been to place patients in a thumb-immobilizing spica cast or splint for 4-6 weeks and then begin rehabilitation exercises. Following this, a gradual progressive rehabilitation protocol is initiated which usually focuses on thumb range of motion, pinch strength, and hand function. This standard form of rehabilitation has shown improvements in pain, function, and satisfaction. However, because these patients are usually kept immobilized until 4-6 weeks post-operatively in order for the tendon graft to incorporate and become stable, stiffness can develop in the thumb as a result. This leads to more time off work and without full and unrestricted use of the hand. Due to their higher pullout strength compared to conventional tendon fixation, the use of interference screws in LRTI procedures may allow for earlier initiation of a more accelerated rehabilitation protocol compared to the standard 4-6 weeks of immobilization prior to rehabilitation. Over the past year at the investigators center the investigators have begun post-operative mobilization and rehabilitation on the first post-op visit at 10-14 days following LRTI with the use of an interference screw. Anecdotally, the investigators have found that their patients have regained their range of motion and function earlier and, in some cases, with larger gains compared to their previous patients they had immobilized for 6 weeks before initiating their rehabilitation. The purpose of this study is to compare patients that have been exposed to the early versus standard rehabilitation protocol to see if there is significant improvement in their range of motion, pinch and grip strength, pain levels and function.

Eligibility Criteria:
Inclusion Criteria:

* clinical and radiographic diagnosis of 1st CMC OA
* failed to improve with conservative modalities
* continued pain over the first CMC joint
* loss of strength or motion of the thumb that limits activities of daily living

Exclusion Criteria:

* rheumatoid arthritis
* gout
* cervical radiculopathy
* previous thumb/1st CMC surgery
* post-traumatic arthritis of 1st CMC
* carpal tunnel syndrome with motor function impairment
* patients with post-traumatic arthritis of their 1st CMC AND have dislocation of this joint.
Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)

It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.

Patients with radiologically early stage lung cancer who are candidates for SBRT will be enrolled in this study. Prior to enrollment, patients are required to be evaluated by an experienced thoracic surgeon, radiation oncologist or medical oncologist to determine operability. Patients will udergo computed tomography (CT) and positron emission tomography (PET) prior to EBUS- TBNA. EBUS-TBNA will be performed at the Interventional Thoracic Surgery Suite (ITSS) located at Toronto General Hospital by a Thoracic Surgeon. The procedure will be performed under local anesthesia with conscious sedation. Mediastinal as well as hilar lymph nodes will be assessed by EBUS-TBNA. The result of pathological diagnosis using EBUS-TBNA will be compared with the result of radiological staging (CT and PET-CT). Patients who are negative for mediastinal lymph node metastasis by EBUS-TBNA will undergo SBRT. In addition, the treatment outcome will be evaluated based on the clinical chart review.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT
3. Performance status score (WHO/ECOG) of 0-2.
4. Cytological or histological proof of non-small cell cancer
5. Stage T1-2 disease, with no evidence of distant metastasis
6. Patients are screened by both computed tomography (CT) and positron emission tomography (PET)
7. Medically inoperable for surgical resection
8. Patients who refused surgery

Exclusion Criteria:

1. Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
2. Active systemic, pulmonary, or pericardial infection
3. Patients who are pregnant or lactating
4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression).
5. Inability to give informed consent
The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development.

Attention Deficit/Hyperactivity Disorder (ADHD) is very prevalent and tends to continue from childhood to adult life. It's heritability is 76%. It was found that there is a greater ADHD prevalence in first-degree families of ADHD subjects- 4-6 times more than the general population.

Pharmacological treatment is the first line treatment today in ADHD, in children and adults, and Methylphenidate (specially Ritalin IR) is the first medication given for the disorder.

The study includes couples of first-degree family members, both diagnosed with ADHD. Subjects will receive Ritalin IR for 4 weeks and undergo several psychiatric and cognitive questionnaires at each time of the follow-up meeting (a total of 3).

Eligibility Criteria:
Inclusion Criteria:

* couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.

Exclusion Criteria:

* subjects who receive other psychiatric medications: antipsychotic medications, antidepressants medications, anti-anxiety medications or mood stabilizers.
* people who suffer from psychotic disorder, bipolar disorder or other severe psychiatric disorders which are not stabilized.
* Alcohol/drugs addicted.
* people with chronic neurologic diseases.
* people with Autism or mental retardation.
* people with congenital heart defect.
* people with hypertension/tachycardia (\>100 bpm).
* pregnancy or breast feed women.
Bortezomib in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.

OBJECTIVES:

Primary

* Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment.

Secondary

* Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then periodically for 2 years.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)
* Distant metastatic disease (Tx, Nx, M1)
* Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein
* Measurable disease on imaging scan (≥ 1 cm)
* Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy.
* Life expectancy ≥ 3 months
* Karnofsky performance status ≥ 60%
* Negative pregnancy test
* Fertile patients must use an acceptable method of contraception
* No other major illnesses likely to limit survival
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1, 000/mm\^3
* Hemoglobin ≥ 10 g/dL (transfusion allowed)
* Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL
* ALT or AST ≤ 2.5 times upper limit of normal
* At least 4 weeks since prior radiotherapy and recovered
* More than 30 days since any other prior investigational drugs

Exclusion Criteria:

* active CNS metastases
* pregnant or nursing
* myocardial infarction within the past 6 months
* New York Heart Association class III or IV heart failure
* uncontrolled angina
* severe uncontrolled ventricular arrhythmias
* electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Peripheral neuropathy ≤ grade 1
* hypersensitivity to bortezomib, boron, or mannitol
* history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin
* serious medical or psychiatric illness that would preclude study participation
* prior cytotoxic chemotherapy for this cancer
* other concurrent investigational therapy
* concurrent chemotherapy, immunotherapy, or hormonal therapy
Pilot Study of Raltegravir Lipodystrophy IISP

The substitution of raltegravir for the NRTIs will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained virological response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely result in continued virologic efficacy.

A prospective, non-controlled, non-randomized, single center study of a treatment regimen of a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor in combination with raltegravir in patients with HIV-1 infection who have been, and continue to be, fully controlled on a standard HAART regimen of a PI or an NNRTI plus 2 NRTIs, and the effect of the change in regimen on peripheral fat distribution.

This pilot study will contain 30 patients who will be followed over a period of one year starting from the date of the medication change from an NRTI-based regimen to a raltegravir-based NRTI-sparing regimen. Potential changes in fat distribution (fat content as assessed by fat volume) will be measured with serial MRI's of the thighs.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 positive
2. Any patient on a boosted PI plus 2 NRTIs.
3. Visual evidence peripheral fat wasting
4. HIV-1 viral load fully suppressed at least 9mths.

Exclusion Criteria:

1. Historical resistance to PI patient receiving
2. No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
3. No contraindications to serial MRI scanning.
4. No contraindications to utilization of raltegravir.
5. Not currently receiving any medications drug-drug interaction w/ raltegravir.
SCCOR Minorities Observational Study

The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in whom the University of Pittsburgh has already obtained baseline and five year data, in order to enhance bone mineral density and vascular function data collection from minority smokers. Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density. Non-invasive vascular studies will be performed to measure endothelial function. Questionnaires regarding symptoms and activity levels will be administered and a blood sample will be obtained in participants in which blood samples are not already available from the COPDGene study visits.


Eligibility Criteria:
Inclusion Criteria:

* African American male and female subjects participating in COPDGene study

Exclusion Criteria:

* caucasians
* pregnant women
Is There Any Correlation Among Neonates Anthropometry and Neuromotor Behaviour

To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.

The association between anthropometric (birth weight, length and occipitofrontal circumference) measurement and hands-on measurement of above mentioned anthropometric dimensions and demographic dimension (bilateral forearm, midarm, calf and thigh) with neuromotor behaviour were explored.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born between ≥28 weeks and ≤ 42 weeks of gestation
* Birth weight between 1500 and 3000 grams
* Neonates are born under all the classifications of Fenton growth charts (SGA, AGA and LGA)
* Stable Hemodynamics
* Free from infection
* Stable vitals

Exclusion Criteria:

* Dermal conditions
* Chromosomal abnormalities
* History of surgery
* Neural tube defect
* Cardiac abnormally