cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

Primary Objectives

- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy

Secondary Objectives

* To evaluate local control of sites previously progressive on erlotinib following stereotactic radiosurgery (SRS) followed by erlotinib
* To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
* To characterize the toxicity of SRS
* To characterize the toxicity of erlotinib when preceded by SRS

Exploratory Objectives

* To explore if VeriStrat results at initial progression are associated with longer PFS or OS after study treatment
* To explore if VeriStrat results following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib
* To explore whether "poor" VeriStrat signatures ever turn to "good" signatures with the study therapy, and to explore PFS and OS of patients whose signature changes

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 18 years of age or older
* Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
* History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
* Progressive disease following EGFR-TKI therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ and marrow function
* Negative urine or serum pregnancy test for female patients
* Patients who can have children must agree to adequate contraception

Exclusion Criteria:

* Unresolved chronic toxicities greater than 2, measured by CTCAE v4
* Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
* Any history of previous greater than grade 3 toxicity attributable to erlotinib
* Pregnant or lactating female
* Any previous radiation to sites of planned Stereostatic Radiosurgery
* History of another malignancy
* Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
* Evidence of severe or uncontrolled systemic diseases
* Known hypersensitivity reaction or idiosyncrasy to erlotinib
* Psychological, familial, sociological, or geographical conditions
* Any other condition in investigator's opinion jeopardize compliance with protocol
Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW

The LifeSkills Mobile app will be evaluated in a randomized controlled trial (RCT) among 5,000 young transgender women (YTW), ages 16-29 in the United States (U.S.). Study findings will demonstrate if the intervention will reduce HIV incidence.

LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed using a community-based participatory research approach. An RCT assesses the efficacy of the LifeSkills Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online. At baseline and every 6 months through 12-48 months (depending on when the participant enrolled), enrolled participants will complete an online survey sent via a link to their mobile phone and will be mailed an OraQuick In-Home HIV Test kit. We will also estimate the total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as transgender, woman, and/or along the feminine spectrum with a male assigned sex at birth
* Ages 16-29
* HIV uninfected at enrollment visit, verified via HIV home test kit
* Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)
* Able to speak/understand English
* Owns a smartphone or home computer or willing to use one in the study
* Willing and able to provide informed consent/assent

Exclusion Criteria:

* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of the interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
* A positive Home HIV test kit result at baseline; these individuals will be immediately linked to HIV clinical care in their local areas.
Effect of Camel Milk on Insulin and Incretin Response

To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance

Camel milk is used as a traditional remedy throughout the Middle East and Indian Subcontinent for conditions such as type 2 diabetes and dyslipidemia. It is currently unclear how such an effect could be mediated in vivo and studies are limited. We performed this study as a pilot experiment to assess the effects of camel milk on Insulin, Glucose, GLP-1, C-peptide and Lipid profile.

Eligibility Criteria:
Inclusion Criteria:

* Normal glucose tolerance
* BMI \< 30 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus
* Impaired fasting glucose or impaired glucose tolerance
* Lactose intolerance
* Weight loss / gain ≥ 5 kg in the preceding two months
* Use of estrogenic drugs or corticosteroids
* Known hypertriglyceridemia requiring treatment
* History of heart attack, angina or cardiovascular disorder
* History of malignant tumor
* Pregnant or lactating women
* Hemoglobin \< 12 for any reason
* Recent surgery or major hemorrhage
* History of bariatric or metabolic surgery
Postural Orientation In The Use Of School Backpacks

This study will examine the effects of postural orientation in the use of school backpacks among elementary school students.


Eligibility Criteria:
Inclusion Criteria:

* Children from seven to ten years of age. Studing in private elementary school.
Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571

This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).

This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
* Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
* At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
* No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
* ECOG performance status 0-1.
* Meets initial laboratory parameters.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria

* Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
* Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
* Patients with:

  * Contrast allergy.
  * GI bleed ≤ 1 month from study enrollment.
  * Intermittent or chronic oxygen requirements.
  * Pulse oximetry \<90%.
  * Grade 3 dyspnea.
  * History of poorly regulated anticoagulation with warfarin.
  * Edema or fluid retention grade \>1.
  * Neuropathy grade ≥1.
* Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
* Psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months.
* Any type of hearing impairment.
* Known HIV infection.
* Receiving other investigational agents.
Effects of Mesna on Homocysteine in Kidney Failure

The purpose of this research study is to examine the effect of a drug called mesna on the removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein building block) found in the blood of all people, however it is considerably elevated in dialysis patients. People with increased levels of homocysteine in their blood are at increased risk of developing plaque buildup in their arteries and other related problems such as heart attack and stroke. This study will determine if mesna can improve the rate of homocysteine removal from blood during dialysis.

Homocysteine is a thiol amino acid derived from dietary methionine. Elevated plasma total homocysteine (tHcy), termed hyperhomocysteinemia, is a graded, independent risk factor for the development of atherosclerosis. Elevated plasma tHcy can be normalized by supplementation with folic acid and vitamins B6 and B12 in most patients with normal renal function and this treatment has been shown to halt the progression of atherosclerotic plaque.

Over 90% of patients with end-stage renal disease (ESRD) requiring hemodialysis have elevated plasma tHcy. The leading causes of morbidity and mortality in these patients are cardiovascular-related pathologies such as myocardial infarction and stroke. Vitamin supplementation consistently fails to normalize elevated plasma tHcy in patients with ESRD, thus leaving them at increased risk. Plasma tHcy is 70 - 80% covalently protein bound limiting the effectiveness of dialysis as a tHcy lowering treatment.

Mesna (sodium 2-mercaptoethanesulfonic acid) is a thiol-containing drug currently indicated to prevent hemorrhagic cystitis associated with ifosfamide chemotherapy. Mesna has incidentally been shown to deplete plasma thiols in cancer patients undergoing ifosfamide chemotherapy. Mesna acts to exchange with thiols bound to plasma proteins enhancing their renal excretion. In vitro studies in our laboratory have shown that mesna rapidly (within 5 minutes) exchanges with protein bound homocysteine yielding a significantly larger dialyzable fraction of the thiol amino acid.

A pilot study recently completed by our group demonstrated a significant decrease in tHcy in eight hemodialysis patients receiving 12 mg/kg mesna three times a week pre-dialysis for one week. Although this therapy did cause a significant decline in tHcy, mesna failed to reduce tHcy to normal levels. The cumulative effects of mesna administration over a longer treatment period should be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease who have received hemodialysis thrice weekly for at least 90 days
* Serum albumin \> 30 g/L.

Exclusion Criteria:

* Patients who refuse to sign a letter of informed consent
* Women who are or are trying to become pregnant or are breast-feeding.
The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated Informed Consent Form.
2. Good general health.
3. Male or female patients aged \>21 years old.
4. Availability for the 25 week duration of the study.
5. Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.
6. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.

Exclusion Criteria:

1. Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
2. Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
3. Presence of soft or hard tissue tumours of the oral cavity.
4. Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
5. Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
6. History of allergy to Chlorhexidine.
7. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
8. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day).
9. Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
10. Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
11. The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
12. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
13. Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
Relationship of SmartPhone Use Addiction With Musculoskeletal System and Cognitive Flexibility

Smartphones have become a part of everyday life, but with some problems. Researches have pointed out that smartphone addiction can cause both physical and mental problems.

Smartphones have become a part of everyday life, but with some problems. Developments in communication technologies have also improved the capacities and limits of smartphones. This has led to the increased availability of smartphones in daily life. Smartphones have become a part of everyday life, but with some problems. Smartphone addiction has been an important topic of research and discussion as a type of addiction that develops depending on the frequency of smartphone use. Researches have pointed out that smartphone addiction can cause both physical and mental problems. As a result of a study conducted in the literature, continuous use of smartphones has been found to cause sleep disturbances, stress, anxiety, decrease in physical activities and many diseases. In this study, the relationship between the concept of smartphone addiction and musculoskeletal problems and cognitive flexibility in young people will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* University students
* Without any known physical and/or psychological disorders
* Using a smartphone
* Volunteer

Exclusion Criteria:

Have any physical and/or psychological disorders
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-45 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 18.5 and 24.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening.
* Body weight above 100.0 kg
* Subject with any known history of growth hormone deficiency as declared by the subject.
* Subject who is non-naïve to growth hormone treatment as declared by the subject.
Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model

In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Their LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol designed for judging the surgical proficiency when performing a LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will be included. All participants undergo a video training with demonstration of the LLETZ procedure on a training model using a sausage as previously described (Hefler et al. 2014). After the Video Training, the LLETZ procedure will be performed by the study probands and their performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol with 23 consecutive items. The exact time Frame for the assessment of the Primary outcome is within 1 hour after the Video Training. Using metrical and non-metrical items, the construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. The study hypothesis is that the LLETZ Training model as used in this study has construct validity and is therefore a valid Instrument to discriminate between experts and novices. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Eligibility Criteria:
Inclusion Criteria:

* Medical Student
* no previous experience with the Training model
* no previous experience in gynecological surgery

Exclusion Criteria:

* language barrier
* unwillingness to participate
The Cognitive and spOrt Virtual EPIC Training Study

The proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults.

Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 50 and older
* Have access to internet
* Have access to a tablet (i.e. iPad or Android) or a computer

Exclusion Criteria:

* Non-cardiopulmonary limitation to exercise (e.g., arthritis)
* Severe exercise intolerance
* Respiratory disease (e.g., asthma, COPD, COVID-19)
* Mini Mental Scale Examination (MMSE) telephone version lower than 19/23
* Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).