cyrilzakka/clinical-trials huggingface dataset:
A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)
* Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition
* Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
* Required to have a performance status (PS) 0-1

Exclusion Criteria:

* Nonsquamous NSCLC
* Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
* Previous chemotherapy for NSCLC
* Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment
* Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
* Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
Theta Burst TMS for Treatment of Methamphetamine Use Disorder

This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm.

Patients who meet criteria for the study and who agree to participate in the research study will be randomized to an arm of the study by chance (like tossing a coin). The chance of receiving TMS or sham-TMS is equal. They will be enrolled in either the TMS or sham-TMS group (both groups involve 5 TMS or sham-TMS sessions). The study doctor and the participant will not know whether they are in the TMS or sham-TMS group. The purpose of this study is to determine if TMS is a potential treatment for methamphetamine use disorder. TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether a specific type of TMS (intermittent theta burst) over the forehead can produce a reduction in things that may prompt you to want to use methamphetamines.

Eligibility Criteria:
Inclusion Criteria:

* Individuals actively struggling with Methamphetamine Use Disorder
* Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program

Exclusion Criteria:

- Individuals currently struggling with alcohol use and/or benzodiazepine use
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of non-childbearing potential
* Genotype 1 chronic hepatitis C
* Laboratory evidence of HCV infection for 6 months
* Histologic evidence of chronic hepatitis C
* Subjects who have a body mass index (BMI) of ≤35 kg/m² (BMI = weight in kg / height² in meters)
* Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus
* Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

Exclusion Criteria:

* Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin
* Subjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis
* Histologic evidence of hepatic cirrhosis
Pathology, Venous Disease, and Clinical Correlations

Chronic Venous Disease (CVD) has a high prevalence in the general population of the western world. Varicose veins are the main signs of this disease that are characterized by important pathological vessel wall changes. There are also several symptoms that affect the quality of life of affected patients. The aim of this study is to correlate the main histopathological abnormalities with the type and the intensity of the symptoms.

Chronic Venous Disease (CVD) of the lower limbs is a widespread chronic condition of the western world. There are several signs and symptoms that affect quality of life of patients with CVD. One of the main signs of this disease are varicose veins that are enlarged, swollen, and twisting superficial veins. Vessel wall of varicose veins shows a significant histopathological phenotype, characterized by a distortion of structural architecture: endothelial damage, disorganization of muscle bundles and alteration of the composition of the extracellular matrix (ECM). Symptoms may be different, according to disease state, progression and local inflammatory processes. To date, there is no study that correlate the type and the intensity of symptoms with histopathological phenotype.

Aim of this study is to correlate histopathological phenotype with clinical manifestations.

A cohort of patients with varicose veins scheduled for open surgical treatment that will undergo to stab avulsion of varicose veins will be recruited. Subsequently, venous tissue from stab avulsion will collected in order to evaluate the following biomarkers: VEGF (Vascular -Endothelial Growth Factor), PGP 9.5 (Protein Gene Product 9.5), Fibronectin and Matrix Metalloproteinase- 9 (MMP-9).

VEGF has a key role as a regulator of angiogenesis; its expression is highly regulated by hypoxia, in this case induced by venous hypertension. In addition to being a marker of neoangiogenesis, it increases vascular permeability in inflammatory disorders. PGP 9.5 is a marker of the innervation of the vessel wall that plays an important role in the regulation of venous tone. Fibronectin and MMP-9 are direct markers of ECM remodeling and impairment and they have also a role in chronic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with varicose veins scheduled for surgery

Exclusion Criteria:

* Peripheral artery disease
* Malignancy
Forceps vs. Snare IVC Filter Removal

IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.

Currently the optimal method for IVC filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. Both snare and forcep techniques have independently evaluated in literature but have never been compared directly. The proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant females
* Adult patients (age 18 years and older)
* Referred to Interventional Radiology for IVC filter removal
* IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.
* Cook Celect filter or Argon Medical Option Elite

Exclusion Criteria:

* Patients with outside hospital filter placement
* Filters other than Cook Celect or Argon Medical Option Elite
* Implantation period \>6 months
* Evidence of coagulopathy (INR \<1.8, platelet count \>50k)
* Clotting disorder
* Central venous occlusion
* Prior filter placement/removal.
Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar

The goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury

To investigate the traction of the impacted mandibular third molar away from the inferior alveolar nerve by using the orthodontic miniscrew in the maxillary bone and cross-arch elastic power chain as a temporary anchorage device before extraction to avoid injury of the nerve and neurosensory complications.

Eligibility Criteria:
Inclusion Criteria:

* patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve.
* Cooperative patients free of chronic diseases which interfere with needed results (e.g.diseases affect the bone regeneration ).
* Patients with good oral hygiene.

Exclusion Criteria:

* patients with limitation in mouth opening.
* patients with mental or physical disabilities.
* Allergy to anaesthetic components or antibiotics.
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector

This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.

Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.

An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.

The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age \[SGA\] patients, based on RCP)

Exclusion Criteria:

* Cases in which Saizen® is contra-indicated (based on local RCP)
* Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
* Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study
Third Molar: Caries, Periodontal Desease and Quality of Life

Caries and periodontal disease are chronic diseases of the oral cavity. The incidence of caries and periodontal disease can vary depending on the position of the third molar, The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar.

Caries and periodontal disease are chronic diseases of the oral cavity. The presence of third molar teeth can lead to periodontal disease in the region, and often can lead to injuries and damage to the oral health, having a significant impact on the quality of life. The incidence of caries and periodontal disease can vary depending on the position of the third molar. Purpose: The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar. Materials and Methods: The investigators performed a clinical, observational cross-sectional study within 116 patients that were screened attending to evaluate the need for extraction of third molars at of the specialization course of Oral and Maxillofacial Surgery of FUNDECTO-FFO-USP. Caries, periodontal disease and quality of life are the outcomes that were evaluated by the main researcher. Caries lesions were assessed by visual tactile examination and periodontal disease through two probing sites around third molar, considering the presence of periodontal pathology when at least one periodontal probing depth was greater than 4 mm, and both were evaluated by radiograph diagnostic methods. The assessment of oral health related quality of life by Oral Health impact Profile questionary (OHIP-14), applied as an interview. The evaluation of the position of the third molars was made by clinical and panoramic radiographs according to the classification of Pell and Gregory and Winter. Data was treated and analyzed according to STATA 13.0, software with descriptive and inferential statistics. The level of significance used was 95%. Results: partially erupted and angulation of third molar increase the incidence of caries and periodontal disease in these teeth. Symptoms and age are factors associated with caries and periodontal disease. Patients with caries have higher scores in domains 3 and 6 and those with periodontal disease have higher scores in domains 3 and 4. Pathologies on third molar region had impact on domain 7.

Eligibility Criteria:
Inclusion Criteria:

* ASA I patients (negative medical history), with at least one third molar erupted or partially erupted.

Exclusion Criteria:

* systemically compromised
* allergic
* pregnants
* patients who had the four third molars included
* patients who have already undergone the extraction of one of the third molars
Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis

This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery.

This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery.

MCA flow parameters will be evaluated during labor of women with and wthout chorioamnionitis

Eligibility Criteria:
Inclusion Criteria:

* women giving birth week 37-42
* healthy
* one fetus

Exclusion Criteria:

* more than one fetus
* IUGR
* illness or damage to fetus
Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.

challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.

The investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction surgery since January 2016. The objective criterion were based on the international guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy).

The investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. The investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
* Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months and 6-8 mnths after surgery respectively
* Patient who received the information form

Exclusion Criteria:

* Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
* Cognitive or sensory impairment making it impossible to understand the information form
* Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
Phase 1 First in Human Study of ZN-d5 as a Single Agent

Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).

This is an open-label multicenter Phase 1 dose escalation study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 in subjects with (NHL) or (AML) in order to determine the recommended phase 2 dose of ZN-d5.

Eligibility Criteria:
Key Inclusion Criteria:

NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC

* Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease.

AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy.

* White blood cell count \< 25 × 109/L. Cytoreduction prior to treatment is acceptable.
* Subjects may not be pregnant and must agree to use an effective method of contraception.
* Eastern Cooperative Oncology Group performance status ≤ 2.
* Estimated life expectancy of at least 12 weeks.
* Adequate hematologic and organ function, including creatinine clearance ≥ 60 mL/min.

Key Exclusion Criteria:

* Recent interventions including major surgery, radiation therapy, stem cell transplant.
* Treatment with anti-neoplastic agents with 5 half-lives.
* Significant unresolved toxicity from prior treatments including active GVHD.
* Active central nervous system disease.
* Clinically substantial myocardial impairment.
* Prior therapy with venetoclax.
Preventing Prescription Drug Abuse in Middle School Students

This project is designed to test a primary prevention approach to the problem of prescription drug misuse and abuse (PDA) among middle school students. The intervention uses both online e-learning and small group facilitator-led intervention modalities. Middle schools will be randomized to receive the intervention or serve as controls.

While there are a number of drug abuse prevention programs for middle school age youth, relatively few programs focus on preventing prescription drug abuse. Furthermore, due to growing constraints on classroom time, new evidence-based prevention programs are needed that flexibly incorporate the use of online digital technology and classroom/small-group components. The present study is developing and testing an adaptation of the evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The proposed preventive intervention for middle school PDA will (1) utilize both online digital and face-to-face intervention modalities to address PDA and concurrent ATOD use; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD use; (3) discourage diversion of prescription medications; and (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios. Middle schools will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive existing health education programming. At the end of the intervention period, and at a 12-month follow-up assessments, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding PDA and substance use.

Eligibility Criteria:
Inclusion Criteria:

* Middle school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Exclusion Criteria:

* Severe head trauma in the past
* History of seizures
* History of ischemic stroke or hemorrhage
* Pacemaker
* Metal implants in the head/neck region
* Severe comorbidity
* Intake of illegal drugs
* Pregnancy
Drug-coated Balloon in de Novo Chronic Total Occlusions

The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo coronary chronic total occlusions (CTO) undergoing successful CTO recanalization with the use of drug-coated balloon (DCB)-only strategy. The primary endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site

Exclusion Criteria:

* de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
* in-stent CTO