cyrilzakka/clinical-trials huggingface dataset:
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin

The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (with non child-bearing potential)
* Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
* HbA1c \<11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.


Eligibility Criteria:
Inclusion Criteria: Any known risk factor for development of incisional hernia

* \> 60 years
* BMI \> 30
* DM
* Chronic bronquitis
* Smoking
* Neoplasia
* Renal failure
* Liver failure
* Immnusupression
* Urgent operation

Exclusion Criteria:

* Previous supraumbilical midline laparotomy
* Previous incisional hernia
* Emergency surgery
* Life expectancy of less than 12 months
* Patient´s rejection to participate
* Unable to understand and participate
Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection

Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.

The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.

Eligibility Criteria:
Inclusion Criteria:

* All benign soft tissue tumors greater than one cubic cm
* Adults 18 years and older

Exclusion Criteria:

* Pregnant females
* Women who are breastfeeding
* Less than 18 years old
* Malignant tumors
* Tumors smaller than 1 cubic cm
* Allergy to Exparel
* Patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day
* Allergy to amide anesthetics
* bone tumors
* Patients unable to comply with the study standards and follow up
Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer

RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients.

PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.

OBJECTIVES:

* Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
* Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
* Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
* Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.

OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing \[surgery\] vs less impairing \[chemotherapy/radiotherapy\]).

Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).

Cancer treatment and medical history information are gathered from patients' medical records.

Eligibility Criteria:
PATIENT CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Head and neck cancer
  * Lung cancer (control group)
* Must have received treatment for head and neck cancer or lung cancer within the past 5 years

PATIENT CHARACTERISTICS:

* Able to speak and read English to answer surveys, interviews, and questionnaires

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of LY2922470 in Healthy Participants and Participants With Diabetes

The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m\^2)
* Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with Type 2 Diabetes Mellitus (T2DM):

* Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening.
* Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening

Exclusion Criteria:

For all participants:

* Are currently participating in another clinical study or completed one in the last 30 days
* Are allergic to LY2922470 or other related drugs
* Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
* Have electrocardiogram (ECG) readings that are not suitable for the study
* Are infected with hepatitis B
* Are infected with human immunodeficiency virus (HIV)
* Have donated more than 450 milliliter (mL) of blood in the last 3 months or if have donated any blood in the last month
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic.

For participants with T2DM:

* Have had heart disease or stroke within 6 months before entering the study
* Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
* Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
* Have used insulin to control diabetes in the last 1 year
* Show symptoms of high blood sugar, for example (e.g.), frequent urination, always feeling thirsty, or unexpected weight loss
Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)

The investigators will assess changes in breast appearance, graft retention and quality of life over one year in patients who have received direct autologous adipose tissue injection for the treatment of objectionable post-surgical breast deformities. These patients have undergone the resection of breast tissue to treat either benign or malignant breast disease.

During the past decade there has been increased awareness of the potential of free adipose cell grafting to treat a variety of problems in both reconstructive and cosmetic plastic surgery. There have been encouraging reports describing the use of autologous fat grafts (fat tissue harvested by standard liposuction techniques in a given patient and then re-injected at another site) for treating breast deformities in the setting of benign and previously treated malignant breast problems.

There has been a corresponding large scale laboratory investigation effort into the potential of adipose derived stem cells (ADSC's) harvested during liposuction and induced to differentiate into various cell types in the mesenchymal cell line. The potential clinical utility of these cells in the treatment of patients who present with a breast deformity after segmental mastectomy (lumpectomy) and radiation therapy has been described, but not studied in rigorous prospective manner.

The investigators believe that the clinical use of these autologous fat cell grafts have unique advantages in the treatment of breast deformities. The technique is minimally invasive, easily repeated and is associated with minimal surgical morbidity (indeed it may have the advantage of improving the appearance of both the breast deformity and the area from which they are harvested), it typically displays a rapid recovery, a complication rate that is no greater (and probably less than ) established and currently used surgical treatment(s) of these breast problems, and is oncologically safe.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 70 years of age inclusive and able to provide informed consent and
* Subject is 6 months post chemotherapy or radiation treatment and is scheduled for physician evaluation for a standard of care breast fat graft procedure.
* Per PI's discretion is stable post-surgery or who has a benign breast deformity or post segmental breast deformity
* Willing and able to comply with the study schema for research procedures.

Exclusion Criteria:

Age less than 18 years

* Inability to provide informed consent
* Active chemotherapy or radiation therapy treatment for cancer diagnosis
* Not clinically stable to have a surgical intervention
* Active infection anywhere in the body
* Known coagulopathy
* Pregnancy
* Per the PI's discretion, subject is not a candidate for participation in this clinical trial.
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy

This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed HER2-positive MBC
* Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery
* Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment
* Stable systemic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* LVEF at least 50%
* Adequate hematologic, renal, and hepatic function
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Progression of systemic disease at Screening
* Leptomeningeal disease
* History of intolerance or hypersensitivity to study drug
* Use of certain investigational therapies within 21 days prior to enrollment
* Current anthracycline use
* Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use
* Active infection
* Pregnant or lactating women
* Significant history or risk of cardiac disease
* Symptomatic intrinsic lung disease or lung involvement
* History of other malignancy within the last 5 years
Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma

Video-assisted thoracic surgery has a standard role in diagnosis and therapy in thoracic surgery, In the past, most patients necessitating surgical treatment secondary to chest trauma was exposed to open thoracotomy, which was the most morbid of surgical incisions

Video-assisted thoracoscopic surgery has become a popular and acceptable method for diagnosis of intra-thoracic lesions since 1990s with the developments in surgical techniques. It is also used for treatment of retained pleural collections, it is a simple alternative to open thoracotomy. Although it's multiple advantages, timing of surgery and its effects on patients' results are not well elucidated. Multiple studies report that prognosis of patients is better with the earlier interventions in injured chest. However, there is so many differences for the optimal time for surgery in these studies .

Indications of VATS have been extended for management of diagnosis and treatment of chest trauma since 1990. This approach has multiple advantages as chest tube setting, minimally invasive surgery, less postoperative pain, and chest exploration. Today, VATS is used for empyema, persistent pneumothorax, retained haemothorax, mediastinal and diaphragmatic exploration, pleuro-pericardial ruptures, surgery for thoracic duct injury and aspiration of symptomatic foreign bodies.

Eligibility Criteria:
Inclusion Criteria:

1. patient aged more than 13 yards old
2. Hemo-dynamically stable patients with chest trauma
3. Willing and able to provide written informed consent and comply with study requirements.

Exclusion Criteria:

1. patient aged less than 13 yards old.
2. Hemo-dynamically instable patients
3. Head trauma patients.
4. missing informed consent
5. Participation in another clinical research.
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
* Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
* Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

* Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
* Substance abuse or dependence
* History of malignant cancer
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)

The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。

Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. acute ischemic stroke within 10 - 30 days of onset
3. neurological deficit: 6≤NIHSS≤16
4. Large artery atherosclerosis stroke based on TOAST criteria
5. The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
7. fully understand and cooperate with the doctor's instructions.
8. the availability of informed consent;

Exclusion Criteria:

1. Hemorrhagic stroke or mixed stroke
2. Combining with severe organ dysfunction
3. Past hemorrhagic stroke
4. A history of stroke with severe sequelae
5. Planning revascularization in 3 months
6. Ischemic stroke due to surgical intervention
7. participating in other clinical trials within 3 months
8. Pregnant or lactating women
9. any inappropriate patients assessed by the researcher
Yervoy Pregnancy Surveillance Study

The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age


Eligibility Criteria:
Inclusion Criteria:

* Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment

Exclusion Criteria:

* Women whose ipilimumab exposure is outside the window of pregnancy exposure
* Pregnancies for which there is only paternal exposure to Yervoy

Other protocol defined inclusion/exclusion criteria could apply
Is Exercise Program Added to Corticosteroid Injection Effective on Pain and Performance in Plantar Fasciitis?

Plantar fasciitis (PF) involves the degeneration of the medial calcaneal tuberosity and nearby perifascial tissues in the heel. It is the leading cause of heel pain, typically resulting from repetitive strain on the plantar fascia, causing structural damage. Key risk factors for PF include an increased body mass index in active individuals and a greater range of plantar flexion motion. Treatment options for PF vary, and there is no clear consensus on the most effective approach. Conservative treatments may include rest, stretching exercises for the plantar fascia and Achilles tendon, strengthening exercises for foot intrinsic muscles, nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics, heel pads, dorsiflexion night splints, and corticosteroid injections. These treatments may be used individually or in combination. Corticosteroid injections are the most frequently used invasive treatment. However, there has been limited research examining the effects of corticosteroid injections combined with exercises targeting intrinsic foot muscle strength on functionality and walking distance. The objective of this study was to evaluate the impact of an exercise program added to corticosteroid injections on pain relief and functional performance in individuals with PF.


Eligibility Criteria:
Inclusion Criteria:

* Those over the age of 18
* Those who have pain in the plantar region for 1 month and this pain is 5 or more according to VAS,
* Those who describe pain on the first step of the morning,
* Those with plantar fascia tenderness on palpation,
* Patients who will be in harmony with the physician and physiotherapist in exercise and follow-up throughout the entire study period.

Exclusion Criteria:

* Cases with fracture, entrapment neuropathy and rupture,
* Those with neurological and systemic diseases,
* Those with a Body Mass Index (BMI) of more than 40,
* Conditions with a local contraindication to corticosteroid,
* Participants who have situations that may prevent their safety, execution or interpretation of the results during the continuation of the training and applied of the test protocol.
Usage of Spacers and the Relationship With Symptoms Severity in COPD Elderly Patients

The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. A convenience sample was used to recruit patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics from a teaching hospital in Taiwan. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 or above diagnosed with COPD by a pulmonologist.
* Clear consciousness and communication abilities in Mandarin or Taiwanese.
* Consent to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients who are blind, deaf, unable to express themselves, and unable to understand the study explanation.