cyrilzakka/clinical-trials huggingface dataset:
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, \>=18 years of age;
* chronic renal anemia;
* Hb concentration 10.5g/dL - 12.5g/dL;
* continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

* blood transfusion within the previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).
Prospective Sinonasal Cancer Multi-institution Study

This is a multi-institution prospective study of patients with sinonasal malignancies. The goal of this study is to learn more about the course of sinonasal cancer, treatment outcomes, and patient quality of life. In addition, central mutational and genomic analysis of tumor tissue will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 30 days (non-inclusive) and 99 years (inclusive)
* Patients with a diagnosis of sinonasal cancer
* Patients undergoing treatment at Mayo Clinic

Exclusion Criteria:

* Healthy individuals
* Unwilling to sign the informed consent
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.

The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of breast cancer (Stages 0-III)
* Age \<=45
* Premenopausal (at least one menses over past year)
* Has a uterus and at least one ovary

Exclusion Criteria:

* Prior chemotherapy
The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement

Background and purpose:

In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA.

Hypothesis:

Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice.

Participants and methods:

Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life.

Ethical issues:

From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a primary unilateral total knee arthroplasty.
* Age between 18 and 80 years.
* Participants must understand and speak Danish.
* Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre.

Exclusion Criteria:

* Disease/Musculoskeletal disorder, which requires special rehabilitation modality.
* Alcohol and drug abuse.
* Lack of wish to participate or unwillingness to sign an informed consent.
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of NSCLC.
* Unidimensionally measurable disease.
* Documented disease progression within 6 months of the subject's last dose of carboplatin and paclitaxel in treatment arm 1, part 2 of Immunex Protocol 054.0004 (Amgen Protocol 20025404).
* Disease stage IIIB with pericardial or pleural effusion, or stage IV.
* Life expectancy of at least 12 weeks.
* ANC greater than or equal to 1.5 x 10\^9/L, platelet count greater than or equal to 100 x 10\^9/L.
* Adequate hematology function
* Adequate renal function
* Adequate hepatic function
* ECOG score of less than 2.
* Brain metastases, if present, must be controlled and asymptomatic.

Exclusion Criteria:

* Calcium \>ULN (treatment for hypercalcemia allowed).
* Use of any investigational therapy within 30 days of ABX-EGF infusion.
* Any cancer therapy for NSCLC other than paclitaxel and carboplatin per Immunex Protocol 054.0004 (Amgen Protocol 20025404), such as radiation therapy, surgery, or steroids.
* Paclitaxel or carboplatin within 30 days before the first ABX-EGF infusion.
* Radiation therapy within 2 weeks before ABX-EGF infusion.
* LVEF less than 45% as measured by MUGA.
* Symptomatic ventricular arrhythmia or symptomatic conduction abnormality.
* Myocardial infarction within 1 year before first dose of study drug.
* History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ.
* Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment.
* Men not willing to use contraception upon enrollment into this study and for 1 month following treatment.
* Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration.
* Known to be HIV positive.
* Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).


Eligibility Criteria:
Inclusion Criteria:

-Participants with Masseter Muscle Hypertrophy

Exclusion Criteria:

* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
* History of or current temporomandibular joint disorder (TMJD)
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy

The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.


Eligibility Criteria:
Inclusion Criteria:

* Medical authorization to for standing, gait training and weight bearing.
* Maximum user weight of 35 kg.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
* Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy affecting the ability to walk.
* Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
* Patient in follow-up according to the normal standards recommended for his illness.

Exclusion Criteria:

* More than 20º of hip flessum at the time of using the exoskeleton.
* More than 20º of knee flessum at the time of using the exoskeleton.
* Severe skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Refusal of the patient or legal guardian to include the child in the study.
* Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the patient's skin.
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
Molekule for Allergic Rhinitis/Asthma

Exposure to airborne allergens and pollutants is linked to symptom severity of allergies, asthma and other respiratory problems. In this study an air purifier using photo-electrochemical oxidation technology (PECO) will be used in the home environment of study participants. The investigator will assess the reduction of symptoms from allergic rhinitis/conjunctivitis and asthma.

The purpose of this study is to assess the efficacy of the portable PECO air purifier in reducing symptoms from allergic rhinitis and asthma. Using a randomized, double blinded placebo, controlled trial we will be then able to assess if there are any changes after the use of the PECO air purifier after completing an initial baseline survey \& comparing to the exit survey. This is a double-blind study, which means that neither the participant nor the investigator knows which device is being used until after the trial is over.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic allergic rhinitis and/or conjunctivitis by history
2. History of adult asthma requiring medications now or in the past
3. Age ≥18
4. CARAT score less than 24

Exclusion Criteria:

1. Participant is \<18 years-old
2. Use of systemic corticosteroids within 14 days of study initiation
3. Treatment with biologic agents or allergen immunotherapy
4. Treatment with other immunomodulators (cyclosporine, azathioprine, hydroxychloroquine, etc)
5. Sensitive to fan sound or blue/purple light at night time
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.

This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per RECIST criteria.
* Fail second-line or above anti-tumor treatment
* Evaluation is stable disease with a trend of progression.
* Minimum life expectancy 16 weeks
* Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
* ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
* Normal organ function.
* Has signed a Patient Informed Consent Form.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of ≥ 2
* Patients with severe liver and kidney insufficiency
* Deferoxamine Ingredients allergy
* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
* Researchers consider it is not suitable for participation.
Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France

Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment.

In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area.

The aims of the study are:

1. To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
2. To identify risk factors for Coxiella burnetii seropositivity in these populations

In order to estimate seroprevalence and risk factors for Coxiella burnetii infection in humans, the investigators will conduct a cross-sectional study in three groups:

* blood donors at blood donation organizations (general population)
* beef and dairy cattle farmers
* veterinarians involved in a rural practice

All the participants in the study will provide a blood sample and will fill in a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Give a written informed consent
* Be 18 years old and over
* Be able to speak French

Exclusion Criteria:

* Adults under protection (guardianship or curators)
* Contraindication for drawing blood
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®

This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.

The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.

This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patient operated with C-CURVE TITANIUM (MEDICREA) for one or several levels (3 maximum)
* Cage implanted with the bone graft "OSMOSYS" (MEDICREA) or an auto bone graft from patients
* Patient ≥ 18 years
* Patient affiliated to health care insurance (social security in France)
* Patient who signed an informed consent form
* Patient able and willing to complete a self-administered questionnaire
* Patient able to understand protocol and the planning visit and willing to perform all of them
* Patient with a pathology indicated in the instruction for use of the implant

Exclusion Criteria:

* Patient with no preoperative data available (X-rays, questionnaires)
* Hybrid installation or cervical additional fixation
* Patient contraindicated for X-ray(s) and/or CT-Scan(s)
* Patient with contraindications indicated in the instruction for use of the implant
* Patient judged as non-compliant by the investigator, not unable to come back for the follow-up visits (for example: patient living more than 100 km away).
* Patient who declined to participate to the study or unable to give his consent Vulnerable population as explained in the protocol
Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

In this study, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age≥18 years, regardless of sex;
* 2) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase;
* 3) Pre-thrombolysis NIHSS \>= 4, and \<= 24;
* 4) Premorbid mRS 0-1;
* 5) Signed and dated informed consent is obtained;

Exclusion Criteria:

* 1) Patients who have the contraindication of intravenous thrombolysis with alteplase.
* 2) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb.
* 3) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
* 4) Pregnant or lactating women.
* 5) Severe hepatic and renal dysfunction.
* 6) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
* 7) Unwilling to be followed up or treated for poor compliance.
* 8) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
* 9) Other conditions that the researchers think are not suitable for the group.
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20-45 years at screening
* Body weight over 50 kg, inclusive, and within 20% of ideal body weight

Exclusion Criteria:

* Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
* Has a sign or symptom or history related to an acute or chronic pancreatitis
* Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
* Has ever been exposed to exenatide
* Shows SBP \>= 150 mmHg or \<= 90 mmHg or DBP \>= 100 mmHg or \<= 50 mmHg
* Has a presence or history of drug abuse
* Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
* Has been participated in other clinical trial within 2 months
* Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
* Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
* Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
* Subjects not eligible at the discretion of investigators