cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT
* the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.
* KPS ≥60，or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.
* Age: 18-75 years old.
* Adequate end-organ function:

WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range

Exclusion Criteria:

* Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).
* Unable or unwilling to comply with the study protocol.
* The expected survival time is less than 3 months.
* Patients who are anticipated in other clinical trials of brain metastases.
* Patients who has been treated with SRT in other hospitals
* Pregnant patients or female patients whose HCG is positive
* Unsuitable to participate in study, that in the opinion of the treating physician.
Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs).

With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.

This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care.

The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.

As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.

Eligibility Criteria:
Inclusion Criteria:

* T2DM
* Treated in primary care in period 1998 to 2012
* used metformin monotherapy
* subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period
Longitudinal Efficacy of Dental Implants in Anterior Areas

Dental implants are used in dentistry to reestablish function and appearance to areas of the mouth where natural teeth are missing. Implants can be a good choice for almost all areas of the mouth except where the space left by missing teeth is too narrow. This is usually the case when front teeth are lost of have been missing since birth.

The Maximus dental implant is the smallest implant made, just 3mm in diameter, and is especially designed to replace missing front teeth and yet be strong enough to function as a natural tooth.

This study will assess the functional success of BioHorizons Maximus one-piece endosseous dental implant.

We hypothesize that placement of the 3mm dental implant in areas of limited tooth-to-tooth spacing will be an efficacious tooth root replacement.

When maxillary anterior (upper front)and/or mandibular incisors are congenitally missing or lost due to other causes, the space between adjacent teeth is frequently too narrow to support traditional implant therapy and patients are often advised to fill the space with conventional fixed or removable prosthetic appliances.

The one-piece titanium construction of the Maximus design is believed to retain optimal biomechanical stength while remaining small enough for use in anterior reconstruction thereby allowing access to spaces that were previously beyond the scope of implant dentistry.

Eligibility Criteria:
Inclusion Criteria:

* Missing anterior teeth

Exclusion Criteria:

* Pregnancy
* Cigarette smoking
* Diabetes Mellitus
* Other significant medical conditions or habits likely to compromise bone healing
* Chronic use of medications likely to compromise bone healing
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma

The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.

Upon determination of eligibility, patients will randomly be assigned to one of two treatment arms:

* Rituximab
* Rituximab + bevacizumab

For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, you must meet the following criteria:

* Follicular NHL, grades 1 or 2 confirmed by a biopsy sample
* 18 years of age or older
* Evidence of disease progression at time of study entry
* Must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
* Patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
* Measurable or evaluable disease
* Able to perform activities of daily living without considerable assistance
* Adequate bone marrow, kidney, and liver function
* Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

* Treatment with more than two previous chemotherapy regimens
* Prior treatment with bevacizumab or other similar agents
* Progressive NHL less than 6 months after receiving previous rituximab
* More than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
* Spread of NHL to brain or nervous system
* History of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Intracardiac Flow Remodeling in Athletes

The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18yrs old
* Ability to give written consent for participating in the study

Exclusion Criteria:

* Age \< 18yrs old
* Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure
Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients

The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection
* Age \> or equal to 18 years of age
* No prior antiretroviral treatment
* Karnofsky superior to 60%
* CD4 T cells \< 350/µL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250/µL, as nevirapine liver toxicity increases (X10) when CD4 are \> 250/µL
* Written informed consent

Exclusion Criteria:

* HIV-2 infection or co-infection
* Prior antiretroviral treatment
* Intolerance, or contraindication to investigational drugs
* Pregnant or breast-feeding woman, or plan to become pregnant
* Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy
* Biological criteria: hemoglobin \< 10 G/DL, neutrophil count \< 1000/µL, platelets \< 50000/µL, creatinine \> 2N, ASAT or ALAT \> 2.5N, bilirubin \> 2N, hypophosphatemia
* Prevision of poor adherence
* HBC co-infection (Ag Hbs positive) or HVC co-infection (positive HCV PCR)
* Liver failure, alcohol abuse
* Treatment administration not recommended with investigational drugs
* Interferon, interleukin, or HIV vaccine treatment
* Informed consent not obtained
Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects

Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation.

The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

Maximal voluntary ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation. The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

Study design: healthy subjects with normal lung function will perform MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) will be measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeares at a given frequency, only one additional MVV at a higher breathing frequency will be conducted to confirm DH.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* History of asthma, obstructive syndrome on basic lung function
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.

Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.


Eligibility Criteria:
Inclusion Criteria:

* Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
* Tumor visible by ultrasound at time of treatment;
* Unifocal primary disease;
* Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
* Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
* Planned lumpectomy

Exclusion Criteria:

* Pregnant patients
* Multifocal or metastatic disease
* Planned neoadjuvant chemotherapy or radiation
* Extensive ductal carcinoma in situ (DCIS; \>25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
* Known allergy to both lidocaine and benzocaine
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector

The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.

This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of CBT based treatments for GAD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with GAD and the long-term negative consequences of this condition. Participants in this study are recruited in general health settings. Patients meeting criteria for enrollment will be randomly assigned to receive either cognitive behavior based therapy or treatment as usual. Assessments for all participants will be collected at baseline, post-treatment, and at two months follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GAD
* 18 to 65 years
* Spanish speaker
* able to read and write
* plan to continue receiving services in the health care setting during the next six months

Exclusion Criteria:

* severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence
* clinically judged to have a high acute suicide risk
* life-threatening medical condition
* currently receiving psychotherapy
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer.

Primary objective:

1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment.

Secondary objectives:

1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
3. To determine procedure related complications


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non-small cell lung cancer
* Patients who have initially histologically proven N2 disease (Stage IIIA)
* Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
* Written informed consent

Exclusion Criteria:

* Contraindications for bronchoscopy
* Medically inoperable patients
* Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

1. Ruptured saccular aneurysm repaired by neurosurgical clipping
2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair

Exclusion Criteria:

1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
2. Angiographic vasospasm prior to randomization
3. Evidence of cerebral infarction with neurological deficit
Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.
Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection

The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included.

To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis.

The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included. The four hospitals included the 1st-3th XiangYa Hospitals and Hunan Provincial People's Hospital. Organize the data.Patients with a course of treatment \< 4 days and shedding were excluded.To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis. The chi-square test was used for the counting data, and the Mann-Whitney U test or Kruskal-Wallis H test was used for the measurement data. The significance value was adjusted by Bonferroni correction method for multiple tests, and the P was tested on both sides,P\>0.05.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients receiving tigecycline or polymyxin B treatment;
* Age 14-95, gender unlimited;
* there are clear infections and strains;
* The patient and/or his/her family agree to sign the informed consent voluntarily.

Exclusion Criteria:

* Patients with treatment of less than 4 days;
* patients with abscission;
* Pregnant patients;
* Patients with age \< 14 years or \> 95 years.
Evaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food Allergy

The objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. The handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. Parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). Participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome measures and satisfaction with the handbook. Parents in the control group will receive the handbook following the conclusion of their participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children ages 0 to 18 years newly diagnosed with food allergy (within the past 12 months)
* Child's food allergy has been diagnosed by a physician
* Child has been prescribed an epinephrine auto-injector

Exclusion Criteria:

* Non-English speakers, as the handbook (study intervention) is only available in English at this time.
Food Effect of VS-6766 in Healthy Adult Subjects

An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766

This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.

On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
2. Must follow protocol specified contraception guidance.
3. Continuous non-smoker who has not used tobacco/nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
4. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
5. Medically healthy with no clinically significant medical history.
6. Able to swallow capsules.
7. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Presence of systemic or severe infection.
2. History or presence of a significant medical condition or disease which is not completely resolved.
3. History or presence of alcohol or drug abuse
4. History or presence of hypersensitivity or reaction to the study drug or related compounds.
5. History of tuberculosis.
6. Presence of any fever within 2 weeks prior to first dosing.
7. Females able to have children.
8. Females who are pregnant or lactating.
9. Presence of HIV.
10. Must be able to refrain from using any drugs, including prescription and non-prescription medications beginning 28 days prior to the first dosing.
11. Lactose Intolerance.
12. Donation of blood or significant blood loss or blood transfusion within 56 days prior to the first dosing.
13. Plasma donation within 7 days prior to the first dosing.
14. Participation in another clinical study within 30 days prior to the first dosing.