cyrilzakka/clinical-trials huggingface dataset:
Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* New diagnosis of breast cancer stage I-IV
* Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
* Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen:

  * Concurrent trastuzumab at standard doses is allowed
  * Concurrent pertuzumab at standard doses is allowed
  * Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
* For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion.

Exclusion Criteria:

* Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
* Baseline alopecia (defined CTCAE v5.0 grade \> 1)
* Subjects who are scheduled for bone marrow ablation chemotherapy
* Male gender
* Age \>/= 75 years
* Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.
* Subjects who have had prior chemotherapy
* Subjects who have had \>/=1 previous chemotherapy exposure resulting in alopecia
* An existing history of scalp metastases or suspected presence of scalp metastasis
* Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy
* Previously received, or scheduled to undergo skull irradiation
Hypercoagulable Parameters as Predictors of Thrombotic Events and Prognosis in Patients With Advanced Non-Small Cell Lung Carcinoma

The association between cancer and thrombosis is well known and the occurrence of thrombotic complications is commonly associated with poor prognosis. The aim os this study is to determine the possible value of hypercoagulable parameters as prognostic parameters in advanced non-small cell lung carcinoma (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC.
* normal serum bilirubin
* informed concent to participate in the study

Exclusion Criteria:

* anticoagulant therapy
* infectious disease
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years

The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same group of infants who were born very preterm.

The objective of this randomized crossover study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III are higher than scores on the Bayley Scales of Infant Development-II in the same group of infants who were born very preterm. First, however, the investigators must demonstrate that significant "learning" does not occur when the tests are administered 4-8 weeks apart. The investigators hypothesize that scores on the Bayley-III will be higher than scores on the BSID-II, irrespective of the order in which the tests are administered.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<2000 grams and \<32 weeks
* Corrected age of 18-22 months.

Exclusion Criteria:

* English is not the primary language in the child's home.
* Parent is unable to give informed consent for research participation.
* Parent is unable to commit to returning for follow-up testing in 4-8 weeks.
* Infant has severe medical illness or disability expected to impact his/her ability to participate in testing (ex: blindness, deafness, severe cerebral palsy, autism, tracheostomy).
* No exclusion for economic status, gender, race or ethnicity.
* Participation in a RCT that restricts timing and administration of developmental testing.
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta

This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD.

The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescent outpatients between 12 to 17 years of age (inclusive).
2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview.
3. Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.

Exclusion Criteria:

1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease.
2. Clinically significant abnormal baseline laboratory values
3. History of seizures
4. Active tic disorder
5. Pregnant or nursing females
6. Mental retardation (intelligence quotient \[IQ\] \< 75)
7. Organic brain disorder
8. Eating disorders
9. Psychosis
10. Current bipolar disorder (current episode)
11. Current depression \> mild (CGI-S \> 3)
12. Current anxiety \> mild (CGI-S \> 3)
13. Substance abuse or dependence within the past 2 months
14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (\< 3 months)
15. Recent change in benzodiazepines (\< 3 months)
16. Concerta non-responder
Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers

The investigators previously developed a cigarette cue extinction treatment (CET) procedure in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that triggers it. This is accomplished through repeated exposure to that trigger, while removing the patient's ability to act out the conditioned response. In the present study, the trigger is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving. In the procedure the investigators have previously developed and intend to use again, the participant is shown a pack of his brand of choice cigarettes. The researcher removes a cigarette from the pack, lights it, and asks the participant to hold the cigarette without smoking it for 90 seconds. This procedure is repeated seven times over the course of a six-hour lab session. The investigators hope to boost the clinical response to smoking cue exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS). Behavioral extinction training is a form of learning that may be modulated by NMDA receptor mediated glutamate transmission. The study's main hypothesis is that the partial NMDA receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking treatment. Development of an effective treatment strategy to enhance the effectiveness of NRTs would have a direct and significant positive impact on public health.


Eligibility Criteria:
Inclusion Criteria:

1. Seeking treatment for nicotine dependence
2. Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests, with a negative pregnancy test for females.
3. A DSM-IV diagnosis of nicotine dependence with physiological dependence. Has smoked at least 15 cigarettes daily for at least two years.
4. Able to perform study procedures.
5. Males or females between the ages of 21-55 yrs.
6. Female Participants agree to use an effective method of birth control

Exclusion Criteria:

1. A DSM-IV diagnosis of lifetime history of abuse or dependence on alcohol or drugs other than nicotine
2. Current Axis I diagnosis or current treatment with psychotropic medications (within last three months).
3. Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
4. Participants on parole or probation
5. History of significant recent violent behavior, e.g., one or more incidents of violent behavior in the past year resulting in physical damage.
6. Unstable medical condition, Blood pressure \> 140/90, Pregnancy.
7. History of allergic reaction to nicotine patch.
8. History of hypersensitivity to cycloserine.
9. Any history of seizures
10. History of renal disease.
Computer-based Skin Aging Simulation for Skin Cancer Prevention

This pilot study is to assess the knowledge, attitudes, and practices regarding skin cancer prevention in young adults and to determine the impact of artificial intelligence-based simulation of facial skin aging on their attitudes regarding skin cancer prevention.

In young adulthood an increasing UV-exposure often starts because of the belief that tanning increases attractiveness\]. Raising awareness and educating students and adults regarding practices for skin cancer prevention are critical since skin cancer is increasing rapidly worldwide. Skin cancer preventive interventions for adolescents are needed to improve their motivation for sun safety behavior. This pilot study is to assess the knowledge, attitudes, and practices regarding skin cancer prevention in young adults and to determine the impact of artificial intelligence-based simulation of facial skin aging on their attitudes regarding skin cancer prevention.

Eligibility Criteria:
Inclusion Criteria:

* healthy female volunteers
* written,Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved informed consent.

Exclusion Criteria:

* skin diseases requiring medical therapy
Multiple Sclerosis Rehabilitation Study

The effects of routine rehabilitation in MS patients versus no rehabilitation.

Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a "control" group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2).

Exclusion Criteria:

* Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS\>2.-
Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer

The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.

See Brief Summary.

Eligibility Criteria:
Inclusion Criteria:

Prostate cancer

Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1)

-

Exclusion Criteria:

central nervous system metastasis

History of autoimmune disease
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis

The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).

A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer.

Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter
2. all brain metastases localized within cerebrum or cerebellum
3. before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits
4. surgical resection for the largest brain metastases has achieved
5. after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm
6. histologically proven non-small cell carcinoma, breast cancer or colorectal cancer
7. primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled
8. an age of 20-79 years
9. no prior surgery or irradiation for brain
10. adequate organ function
11. written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted)

Exclusion Criteria:

1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer
2. pregnant or breast-feeding women
3. severe mental disease
4. allergic to gadolinium contained contrast agents
Obesity and Goal-directed Intraoperative Fluid Therapy

The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI\> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery.

Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.

Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.

Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections.

Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.

It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese (BMI≤ 30kg/m2) and obese patients (BMI \> 30 kg/m2)
* undergoing laparoscopic elective fundoplication or elective bariatric surgery

Exclusion Criteria:

* decompensate heart failure
* documented coronary artery disease
* renal insufficiency
* severe chronic obstructive pulmonary disease
* symptoms of infection or sepsis
* esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).
Effect of Social Media on Parental Oral Health Promotion

The study aims to measure the effectiveness of social media in raising parental oral health awareness.

Health Education is a key element in Health promotion. Oral health awareness has a pivotal role in community prevention programs. The methods used for health education have developed through the years to fit the population's needs and to cope with the technological revolution. Nowadays social media has become the easiest, fastest, and most acceptable portal for people. However the benefits of social media are huge for health communication, the shared information should be assessed and monitored for quality and reliability and the privacy of the users should be secured, up to our knowledge there is no reliable source for education on promoting oral health on the social media platform in our community, Although the traditional methods to educate parent like visiting the dentist are more common, Studies show that parents and children had little recollection of any preventive oral health conversations when visiting the dentist. we use oral health Information based on AAPD guidelines that we be provided on social media platforms and then measure the effectiveness of social media in raising parental oral awareness

Eligibility Criteria:
Inclusion Criteria:

1. Parents who volunteer to participate
2. parent have access to social media networks \& smartphone.
3. Parents of infants and toddlers
4. parents of primary school children.

Exclusion Criteria:

1. parent who do not volunteer to participate
2. parent have Low educational standard (unable to use smartphones).
3. Parent of middle school children
PBMT on Muscular Performance and Recovery in Different Time-points

Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.

This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5 mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after the eccentric exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* not athletes or who engage in physical activity at most once a week
* Individuals should not present a history of musculoskeletal injury in the hip and knee regions in the two months prior to the studies
* they should not be using pharmacological agents and / or nutritional supplements
* They must attend 100% of the data collections.

Exclusion Criteria:

* Individuals who do not meet the criteria mentioned above or who present musculoskeletal damage during collection were excluded from the study.
A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)

DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in Europe.

The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of use of new users of aclidinium bromide (monotherapy or in combination) and new users of other medications for chronic obstructive pulmonary disease (COPD); to evaluate the potential off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of patients for whom there is missing information in the risk management plan (RMP); and to establish a core cohort of new users of aclidinium bromide for the future evaluation of safety concerns described in the RMP.

The data source for these studies will be the CRPD in the UK, the GePaRD in Germany, and national health databases in Denmark.

DUS1 will be conducted when the target number of new users of aclidinium monotherapy is reached, and DUS2 when the target number of new users of aclidinium fixed-dose combination with formoterol is reached.

As this was a descriptive study no primary or secondary endpoints were specified.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases:
* To have at least 1 year of enrolment in the database (DUS1 and DUS2).
* To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1
* To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2

The same inclusion criteria will be applied for each of the comparator drugs.

Exclusion Criteria:

* No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.