cyrilzakka/clinical-trials huggingface dataset:
A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* General good health
* Persistent asthma, with an FEV1 50-80% predicted.
* Ability to perform spirometry in an acceptable manner as per protocol guidelines.
* Ability to perform PEFR with a handheld peak flow meter.
* Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
* Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
* Non-smokers.
* Capable of understanding the requirements, risks, and benefits of study participation.
* Other inclusion criteria apply.

Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of severe milk protein allergy.
* History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
* Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
* Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
* Other exclusion criteria apply.
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
* Measurable disease;
* Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
* Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;

Exclusion Criteria:

* prior therapy for recurrence;
* platelets \< 75,000;
* prior Epidermal Growth Factor Receptor (EGFR) therapy;
* interstitial lung disease;
* primary of nasopharynx
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 year old,
* Patients who signed the consent form and accepted to participate to the trial,
* New cardiac electronic device implantation or cardiac electronic device battery change,
* Surgical procedure planned in ambulatory care.

Exclusion Criteria:

* Communication limitations,
* Surgical procedure planned in sedation or narcosis,
* Severe sensorial deficits (visual, auditory),
* Claustrophobia,
* Known motion sickness,
* Patient isolated or with contact precautions,
* Known or anticipated psychiatric diseases,
* Patient known for epilepsia,
* Opened scar and or ongoing infection at the level of the face and/or eyes,
* Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.
SEBBIN INTEGRITY Round Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18-year-old.
* The patient is a woman.
* The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants.
* The patient has been informed of the study, has read the patient information letter and provided consent in writing.

Exclusion Criteria:

* The patient is pregnant or breastfeeding.
* The patient has silicone implants somewhere else than in the breast.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  * History of implant-associated anaplastic large cell lymphoma (BIA-ALCL).
  * Symptomatic autoimmune disease.
* The patient has a pathology that could delay healing (does not apply to the reconstruction group).
* The patient has cancer (does not apply to the reconstruction group).
* The patient has anatomical or physiological conditions that could lead to postoperative complications.
Effect of Moisturizer on Malaysian Women Facial Skin

The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:

1. The effect of Product X on skin hydration of middle-aged women in Malaysia.
2. The effect of Product X on skin elasticity of middle-aged women in Malaysia.
3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
4. To observe any adverse effect occurrence with the use of Product X.

Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.


Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizen
* Middle-aged woman (40-60 years old)

Exclusion Criteria:

* Participants taking isotretinoin
* Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
* Participant who undergo any cosmetic procedures such as laser \& light treatment for the past three months.
* Participant with a history of facial surgery.
Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis

This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.

Resection could prolong the survival of colorectal liver metastasis patients, however,the curative resection rate was still low and more than 2/3 of the patients would experience tumor recurrence.This study was designed to formulate a more accurate and individual evaluation system via the multivariate analysis.

Up to now, there was no data to demonstrate the addition of cetuximab to perioperative chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was also designed to elucidate this question and to observe the objective response rate(ORR) and the safety data of the regime.

Eligibility Criteria:
Inclusion Criteria:

* good performance status
* pathologic diagnosis of colorectal cancer
* Rat sarcoma viral oncogene homolog(RAS) wild-type
* radiologic confirmation the resectability of liver metastases
* enough future liver remnant
* Clinical Risk Score≥3
* treatment naive
* extra-hepatic metastases could be resected completely, if exist

Exclusion Criteria:

* poor performance status, could not tolerate chemotherapy or operation
* other malignancy history or synchronously
* extra-hepatic metastases could not be resected completely, if exist
* received other treatment previously
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

* Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or
* Cohort 2) Subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed carcinoma of the breast
* Locally advanced and/or metastatic disease
* Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
* Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or Cohort 2) \> 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
* ECOG performance status ≤ 1
* Have adequate organ function

Exclusion Criteria:

* Prior enrollment into a clinical trial of a PARP inhibitor
* CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
* Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated \>5 years prior to study enrollment with no subsequent evidence of recurrence
* Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
* Known hypersensitivity to any of the components of talazoparib
Effects of Exergame, Conventional Exercise, and Mixed Exercise On Proprioception, Balance, & Mobility on Males Elderly

Falling of the elderly as one of the greatest issues and major health problems among the elderly population has produced a further discussion among gerontologists and physical therapists. Moreover, they are considered as one of the major health problems among the aging population and by now around a third of 65-year-old adults fall as a minimum once a year while 6% of such falls cause fractures. Loss of the balance is the main reason for falling among the elderly. Proprioception is the sensory feedback regarding the joint position sense and movement which can accordingly lead to a decrease in the postural stability and steadiness of the elderly people. Proprioception has shown to be a risk factor for falls in older people. proprioception can be modified by physical training. Recently, exergaming, the playing of video games with body movements, has been proposed as effective strategy to deliver exercise.

Aim of study: the current research investigates the effect of 8 weeks videogame game exercise, conventional balance exercise, and a combined of the two (mixed training) on knee proprioception, static balance, and mobility of elderly male. Methodology: The study was designed as a single-blinded, randomized, controlled intervention trial. Sixty-four male ages 65 years and above were randomly assigned into an exergame group, a traditional balance exercise group, a mixed training group or a passive control group. After pretest all participant perform 8 weeks of exercise and measured the effects of the training regimens on proprioception and other functional outcomes as well as mood states in healthy older adults.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects should be 65 years old and above.
2. The participants should be able to walk independently for a minimum of 10 meter.
3. The participants should be able to do their daily activities such as eating, going to bathroom, and taking a shower.
4. The participants should be able to do low-level balance exercise

Exclusion Criteria:

1. The participants who had cognitive problems.
2. The participants who could not walk and do their daily activities independently.
3. The participants who have knee fracture or joint replacement.
4. The participant who had regular balance exercise or resistance training in lower body in past 3 months.
5. The participant who had neurological and cardiovascular problem
Effects of Acupunch Exercises on the Frail Older Adults in Long-Term Care Facilities

Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.

Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The cause of frailty is multifactorial. Regular exercise intervension could improve frailty condition and general functional fitness. The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.

Eligibility Criteria:
Inclusion Criteria:

* frail older adults
* aged 65 and above
* had lived in the long-term care facilities more than 3 months

Exclusion Criteria:

* dementia patient
* psychiatric patient
* spinal cord injury patient
Long-term Registry of Patients Treated With Loncastuximab Tesirine

Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.

The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Inclusion Criteria:

* Must be ≥ 18 years of age at the time of consent.
* Initiated or initiating commercially available loncastuximab tesirine treatment.
* Written informed consent must be obtained prior to any registry activities.

Exclusion Criteria:

* Prior loncastuximab tesirine exposure in clinical trials.
Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

1. Women
2. Able to provide written informed consent
3. Able to read and understand English or Spanish
4. Postmenopausal (including concurrent use of ovarian suppression)
5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- metastatic or locally advanced unresectable breast cancer
6. Initiating first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g. palbociclib, ribociclib or abemaciclib). Participants can be enrolled up to 2 weeks after starting CDK4/6 inhibitor
7. Having not consistently engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
9. Having not consistently engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months
10. Approval from a medical oncology provider to participate.

Exclusion Criteria:

1. Unable to provide consent
2. Unable to read or understand English or Spanish
3. Oxygen dependent
4. Unstable cardiac disease
5. Insulin-dependent diabetes
6. Unable to walk 2 blocks without assistance (excluding canes)
7. Unstable bone metastases
8. More than 15 days from initiation of first- or second-line endocrine therapy in combination with a CDK4/6 inhibitor
Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
* EUS or MRI stage T3-4, any N, M0.
* Adequate bone marrow (defined as peripheral absolute granulocyte count of \> 2,000/μL, and platelet count of\>100,000/μL), liver (bilirubin \< 1.5 mg/dl), and renal functions (creatinine \< 1.5 mg/dl).
* Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
* No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
* Patients must have a life expectancy of at least 16 weeks.
* Performance status of \< 2 (Zubrod scale).
* No biopsy proof of lymph node metastases outside the study field.
* No evidence of metastatic disease to distant organs.
* No presence of concurrent or previous malignancies \< 5 years, other than noninvasive skin cancer.
* No uncontrolled or severe cardiac disease, diabetes or hypertension.
* Signed study-specific consent form prior to study entry.

Exclusion Criteria:

* Evidence of metastatic disease
* Prior chemotherapy or radiotherapy
* Patients with a past history of cancer
* Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
* Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
* Cardiac failure or Sever Pulmonary disease
* Patients with impaired gastrointestinal absorption for whatever reason
* Patients medically unfit for cisplatin or taxol chemotherapy
Cytokines and the Risk of Infection in Liver Cirrhosis

The aim of this study is to test whether the oscillation of cytokine concentrations in serum is able to predict the development of infection in patients with liver cirrhosis.

Patients with liver cirrhosis frequently develop bacterial, viral or fungal infections which are the main trigger for decompensation of cirrhosis and development of complications and thereby infection hugely impacts morbidity and mortality in these patients. However, there is no clinical test available that allows rapid, on-site decision making if a patient is likely to develop an infection. The purpose of this study is to measure cytokines interleukin (IL) 6, IL8, IL10 and TNFalpha in patients with liver cirrhosis over a long follow-up period and test whether these inflammatory markers are able to predict the occurrence of infection before it becomes clinically significant. For this purpose, one hundred fifty consecutive patients with diagnosis of liver cirrhosis will be followed bi-monthly for 18 months. Blood samples will be collected for the cytokine measurements and infection cases will be reported at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical, radiological and/or histological evidence of liver cirrhosis
* Age above 18 (inclusive) at the time of screening
* Able and willing to give written informed consent and to comply with the requirements of the study

Exclusion Criteria:

* Infection during the last 14 days before screening
* Gastrointestinal bleeding within the last 14 days before screening
* Antibiotic therapy at the time of screening (except prophylaxis of spontaneous bacterial peritonitis)
* Shock or cardiac failure requiring inotrope treatment at the time of screening
* Hepatic encephalopathy grade \>2
* Findings suggestive of organic nephropathy or a serum creatinine level of more than 2 mg/dl
* Human immunodeficiency virus infection at time of inclusion
* Use of immunomodulating agents within one month prior to screening (e.g. steroids)
* Any disease (e.g., advanced neoplasia) that could affect the short-term prognosis
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Suture Materials: an Evaluation

Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.

Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.

Material \& methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.


Eligibility Criteria:
Inclusion Criteria:

* 36 patients
* in need for periodontal surgery
* patients in good general health
* able to sign IC form

Exclusion Criteria:

* patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
* patients who had a present alcohol and/or drug abuse
ADenoVirus Initiative Study in Epidemiology in Spain

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Spain. The planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
* Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
* No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

* Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
* Previous enrolment in the present study.
* Any direct involvement with the study conduct at site or any family link with study site staff.