cyrilzakka/clinical-trials huggingface dataset:
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).


Eligibility Criteria:
Inclusion Criteria:

* The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
* For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
* The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.

Exclusion Criteria:

* Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.
Effect of 48 Hours of Treatment With the Natural Peptide-Hormone GLP-1 in Patients With Chronic Heart Failure

The purpose of this study is to determine whether 48 hours of glucagon-like-peptide-1 (GLP-1) infusion can improve heart function and alter substrate metabolism in non-diabetic patients with heart failure.

Heart failure is a major complication in patients with ischemic heart disease. It has been shown that many of these patients have areas of viable myocardium that are not effectively contributing to heart function.

Further, chronic congestive heart failure is associated with some degree of insulin resistance in both skeletal and cardiac muscle.

GLP-1 is a naturally occurring peptide hormone that acts as an incretin and has been intensively studied by many groups in association with type II diabetes and it has clearly shown its glucose lowering potential with very little risk of hypoglycemia in several trials.

Recently GLP-1 has been shown to improve cardiac function in dogs with pace-induced cardiomyopathy, and in an open-labeled study it did improve cardiac function in patients with acute myocardial infarctions.

Comparison: 48 hours of treatment with intravenous GLP-1 compared to placebo. Effect on global and regional left ventricular function, exercise capacity, insulin sensitivity and substrate metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Chronic congestive heart failure
* Ischemic heart disease

Exclusion Criteria:

* Diabetes
* Exercise limiting disease other than heart failure
* Congenital heart disease
* Arterio-venous shunts
* Renal failure
* Valvular heart disease
Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females

The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.


Eligibility Criteria:
Inclusion:

1. Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1.
2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
3. Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day.

Exclusion:

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).
A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, \> 18 years of age
* Mild to moderate asthma requiring treatment with an inhaled corticosteroid
* Diagnosis of asthma for at least 6 months

Exclusion Criteria:

* Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
* Subjects with severe asthma, as judged by investigator
* Any significant disease or disorder that may jeopardize a subject's safety
Orthopaedic Treatment Proximal Humeral Fractures

Prospective non-randomized, open, unicentric observational study to compare two different treatments for Three-four parts fractures of proximal humerus (Neer's Classification) in elderly patients (over 75 years old). Both technics are: Sling inmobilization and shoulder arthroplasty.

The investigators propose an observational study that aims to assess:

* Primarily, the functional results of a cohort of 20 pacients presenting fractures of 3 and 4 parts of proximal humerus (according to (Neer's Classification) that will be treated orthopedically (this is, non-surgically). This patients will be recruited in the emergency room of our center, and after being diagnosed of their fracture, will be treated with a sling for three weeks and subsequent rehabilitation treatment. Our intention is to assess the function of the injured shoulder using functional scales (ASES, DASH and Constant score, and VAS scale) at the time of three and twelve months from the date of the trauma.
* Secondly the investigators want to compare the results obtained in this cohort with the results of a historical cohort of patients operated in our center with the same type of fracture. Both types of treatment (non-surgical and shoulder prosthesis) are valid for this type of fracture, and endorsed by the scientific literature.

The investigators consider this to be an observational study since it assigns a single cohort of patients a single treatment (ie non-surgical treatment). The conservative treatment for this fractures is part of routine medical care, and the object of this study is to evaluate the effect of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* 75 years or older.
* 3 or 4 parts fracture (Neer's Classification).

Exclusion Criteria:

* Comorbilities affecting to functional recovery.
* Fractures associating shoulder dislocation.
* Open fractures including neurovascular damage.
* Polytraumatized patients
Hot Flashes and Omega 3

The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.


Eligibility Criteria:
Inclusion Criteria:

* menopause or peri menopause
* complaining of hot flashes
* social security affiliation
* informed consent form signed

Exclusion Criteria:

* primary pathology which can lead to hot flashes
* allergy to omega-3 fatty acids
* allergy to sea products
* High consumption of fat fish or produced by the sea
* iatrogenic hot flashes
* actual omega-3 fatty acids consumption or in the 3 last months.
* consumption of drug or other products for hot flashes in the last month
* protected persons (L1121-5 to L1121-8 of French Public health code)
JiAngSu Maternal and INfant HEalth Database

With the implementation of China's universal two-child policy and a notable rise in adverse pregnancy outcomes, leveraging electronic health records (EHR) has become crucial for enhancing maternal health. Given the mature construction of the information platform and the well-established maternal and child health service system in Jiangsu Province, this study used the Jiangsu Health Information Platform to carry out the research on the JiAngSu Maternal and INfant hEalth database (JASMINE), which involved over 1.5 million mother-child pairs in Jiangsu Province.

JASMINE enables longitudinal follow-up of pregnant women and their offspring, facilitating the exploration of early-life exposures and their long-term outcomes through comprehensive data linkage. This longitudinal approach helps to clarify the relationship and etiological significance of risk factors associated with adverse pregnancy outcomes.It also permits the exploration of the health trajectory of women and children throughout their lives.

From January 2020 to December 2023, JASMINE has recorded extensive maternal and child health data, including socio-demographics, healthcare services, medications, and clinical outcomes.Additionally, it contains longitudinal measurements on risk factors for adverse pregnancy outcomes, which provides a robust foundation for future real-world studies of dynamic predictive models. This study has been approved approved by the Institutional Review Board of Nanjing Medical University.

Ultimately, this research aims to identify key predictors of adverse pregnancy outcomes and inform public health policies to improve maternal and child health in Jiangsu Province. Future directions will include developing targeted interventions based on study findings to enhance health outcomes for mothers and infants.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women and their offspring who registered at the Jiangsu maternal and child health information platform.

Exclusion Criteria:

* None.
Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer, Using a Machine Learning Algorithm and Patterns of Disease Distribution at Laparoscopy (PREDAtOOR)

PREDAtOOR is a pilot study and this study aims at improving the selection of the best treatment strategy for patients with advanced ovarian cancer by using Camera Vision (CV) to predict outcomes of cyto reduction at the time of Diagnostic laparoscopy.

For the treatment of advanced ovarian cancer, the decision to undergo primary surgery is complex and decided by the surgeon while multiple considering multiple elements. Sometimes, chemotherapy is needed before surgery to shrink some of the tumours. To choose the best patients for primary surgery, several prediction tools have been developed. CT and MRI have most commonly been used to identify sites and amounts of tumors in the abdomen and can help determine if these tumours can be safely removed by surgery. However, these imaging methods are only a prediction, and sometimes a diagnostic laparoscopy (putting a camera in the abdomen to look at all sites of disease) is performed to help this decision process.

With the introduction of artificial intelligence and machine learning, there is a possibility to create more precise prediction models using images from these diagnostic laparoscopy videos. In particular, the investigators would like to use images from the diagnostic laparoscopy to create machine-learning models to help predict if the tumours can be successfully taken out at primary surgery, or if chemotherapy before surgery would be needed.

The investigators will enroll patients at a one-time point (being the time of surgery) and follow them forward in time and There will be no additional visits other than the surgery.

During surgery time the surgical team takes images however, what makes this different is that these images will be used to help create an algorithm to predict surgical outcomes. These images will be stored in a secure database with an anonymous number not linking these pictures to any of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at Fondazione Policlinico Gemelli Hospital, Rome Italy, Trillium -Credit Valley Hospital, Mississauga, Ontario and Princess Margaret Cancer Centre, Toronto, Canada
* Patients fit for cytoreductive surgery
* Patients with a primary diagnosis of suspect Stage III-IV ovarian cancer
* Patients selected for interval cytoreductive surgery after NACT

Exclusion Criteria:

* Patients with pre-operative Stage I-II disease confined to the pelvis
* Patients unfit for surgery
* Lack of information about patients' surgical outcomes and clinicopathological characteristics
* LGSOC, Clear cell and mucinous, non-epithelial histologic subtypes (if available)
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with metastatic or recurrent breast cancer.
* Have been previously treated with both an anthracycline and a taxane.
* Have not received more than two prior chemotherapy treatment programs.
* Have stopped any antitumoral hormonal treatment before you enroll in this study.
* Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.

Exclusion Criteria:

* Cannot follow the study procedures (for example, you cannot swallow tablets).
* Are receiving another treatment for your cancer.
* Have received another experimental drug in the last 4 weeks.
* Have had serious heart disease within last 6 months.
* Are pregnant or breast-feeding.
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot

The current use of Juvederm Voluma XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21. In this particular setting, the intended use of the product Juvederm Voluma XC is to show that the filler works to alleviate stress in high pressure areas in the foot during gait, thus decreasing foot pain and allowing individuals to walk more comfortably.


Eligibility Criteria:
Inclusion Criteria:

* Patient's 40 to 75 years of age
* Foot and ankle disability index of at least 55 (based on the majority of people having moderate difficulty in weight-bearing living) and heavy clinical significance of fat atrophy as evaluated by the principal investigator creating a standard analysis.
* Atrophy of the heel or the ball of the foot will be evaluated in the step wise approach.
* Second a clinical exam by the primary investigator

Exclusion Criteria:

* Patients who do not have high pressure fat pad atrophy
* Patient is being treated for cancer
* Skin infections
* Unhealed or acute foot fractures
* Patients with a decrease in dorsalis pedis or posterior tibial pulses
* Pregnant or breast-feeding
* Patients who have had previous injections with fillers
* Patients with nerve injury or nerve damage to the foot causing symptoms of numbness, tingling, burning, and sharp shooting or stabbing sensations. This criteria shall be determined by a. direct patient feedback. If the patient verbally states that they have numbness tingling burning sharp shooting or stabbing pains in their feet or ankles they will not be included.

  b. Semmes Weinstein Monofilament Testing - Semmes Weinstein monofilament testing will be performed on all patients. The Semmes Weinstein will be performed on the great toe submetatarsal one submetatarsal three submetatarsal five the heel and the dorsum of the foot. If a patient cannot feel the sends Weinstein filament in any of those locations they will be eliminated.
* Active an acute diabetic foot ulceration
* Patients with severe allergies manifested by history of anaphylaxis
* Patients with a history or presence of multiple severe allergies
* Patients with a history of allergies to gram-positive bacterial proteins
* Patients with a history of allergies to lidocaine.
Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in healthy subjects.

In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are 6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150 mg respectively. Blood samples will be collected for safety, PK and PD assessments. After the completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8 subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects aged 18-55 years old (inclusive), male or female
2. Females must be of non-childbearing potential
3. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and weigh at least 50 kg at time of Screening

Exclusion Criteria:

1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
2. Taken an investigational drug within 3 months or 5 half-live, whichever is longer from the Screening date
3. Any liver function panel analyte (LFT) value \> upper limits of normal reference range
4. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening
5. Any condition or finding that in the opinion of the Principal Investigator or designee would put the subject or study conduct at risk if the subject were to participate in the study
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.

The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.

Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.

In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.

To date, no data from randomized study are available in the population of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
* 2 metastatic sites or more;
* Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
* Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
* Pain equal or greater than 4/10 at Visual Analogic Scale
* Unstable vertebrae (SINS score equal or greater than 7;
* Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2

Exclusion Criteria:

* Contraindication to vertebroplasty, including contraindication to cement use;
* Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
* Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
* Neurological deficit due to medullar or radicular compression;
* Participation to another clinical trial with an analgesic intent.
The Collar Post Anterior Cervical Spine Surgery Study

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.

Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.

Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 18 and 80;
2. presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
3. deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
4. able to cooperate in the completion of all study consents, forms and documents. 5. Participants who are able to speak, read and write at an elementary school level

Exclusion Criteria:

1. those with previous cervical surgery;
2. those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
3. those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
4. those undergoing a multi-level non-plated ACDF;
5. those undergoing ACDF at greater than three levels, and;
6. those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.