cyrilzakka/clinical-trials huggingface dataset:
The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism

The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism

Energy drink consumption has gained a lot in popularity and represents one of the most rapidly growing segments of the beverage industry. While regularly discussed in media outlets etc. the cardiovascular effects are not well described or well known. For example, the impacts on various cardiovascular parameters range from improved, decreased, to not impacted at all depending on the source. This can be due to a number of reasons including, study protocol design, study population tested, energy drink product used, volume consumed, etc. Accordingly, this study aims to investigate the impact of acute consumption of a standard commercially available can of energy drink beverage on the following parameters.

* Arterial blood pressure
* Heart rate
* Energy metabolism (oxygen consumption and carbon dioxide production

It is hypothesized that consumption of a 12 oz energy drink will result in modest elevations in arterial blood pressure, heart rate, and energy metabolism relative to when consuming of an equal volume of water.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-30
* Must be free of reported cardiovascular, respiratory, and metabolic diseases.
* Must be caffeine naïve
* Must be fasted

Exclusion Criteria:

* Food allergies
* pregnant women
* Breast feeding women
* Individuals with cardiac, cardiovascular, respiratory, metabolic, and/or neurological disorders
* taking any prescription vasoactive medications
* allergies to spandex/lycra
Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast

Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast

Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast.

Duration of the study: 1 year after initiation of prophylaxis with Emicizumab

Inclusion criteria: boys aged \> 2 years, affected with severe hemophilia A with or without inhibitors

Evaluated outcomes: annual bleeding rate, days of absence from school, the need for additional facteur VIII consumption, satisfaction about the treatment and quality of life.

Tools used to assess quality of life are the Ivoirian version of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version 2 (CHO-KLAT) and EQ-5D

The satisfaction of the parents will be assessed using the patients' global impression of change scale (PGIC).

Eligibility Criteria:
Inclusion Criteria: severe hemophilia A with or without inhibitors -

Exclusion Criteria: parents refusal

-
The Effects of Self Directed Exercise on People With Fibromyalgia

The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to prescriptive exercise. To the investigator's knowledge, no studies have examined the impact on pain and function after multiple sessions of self directed exercise in this patient population.

This study hoes to be a case series exploring the effects of self directed exercise on participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4 week time frame at a self selected pace and intensity on a stationary bicycle. Outcome measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale will be used prior to study participation as well as 4 and 8 weeks following the start of participation.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* a medical diagnosis of Fibromyalgia
* sedentary level of activity prior to entry. Sedentary level of activity is defined as: no participation in regular physical activity more strenuous than slow paced walking for a maximum of 2 times per week for the 4 months prior to study entry.
* signed release from their physician stating that they are able to participate in the study.

Exclusion Criteria:

* presence of an acute or chronic medical condition such as cancer
* infection, cardiovascular or respiratory disease (that would limit their exercise participation), metabolic or musculoskeletal or neurologic condition (systemic lupus or rheumatoid arthritis, or other pain disorders)
* already participating or plan on participating in a regular aerobic exercise program 6 months prior to the study
* ongoing or planned Physical Therapy treatment
* drug dependency
Investigating the Feasibility of a Physical Activity (tele)coaching Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study

The aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated PA tele coaching intervention including smartphone application and stepcounter (Fitbit Charge 4) and 2) a manual PA tele coaching program using only a stepcounter (Fitbit Charge 4) without custom smartphone application but still linked with a smartphone using the Fitbit application and to make population specific adaptations to the intervention for patients with NSCLC after lung resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* Three to nine months after a lung resection surgery for non-small cell lung cancer
* If patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy
* Adults (+18 year)

Exclusion Criteria:

* Progressive or recurrent lung cancer
* Who had other malignancies in the last 2 years
* Psychiatric disorders
* Other ongoing treatments
* Involved in or planned to start a multidisciplinary rehabilitation program
* Unable to learn to work with a new electronic device (e.g. smartphone)
* Not understanding and speaking Dutch
* Patients with comorbidities precluding them from participation in a physical activity intervention
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).

This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.


Eligibility Criteria:
Inclusion Criteria:

* resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
* T1-3, Nx, M0 (UICC 6th version, 2002)
* infiltration of the portal vein (\<180°) is not an exclusion criterion
* cytologic or histologic confirmation of adenocarcinoma
* age \>18 years
* written informed consent

Exclusion Criteria:

* contraindication for Whipple procedure
* an infiltration \>180° of the portal vein
* abutment of the tumor to the superior mesenteric artery
* infiltration of the superior mesenteric artery or the celiac trunk
* chronic neuropathy \> grade 2
* WHO performance score \>2
* uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
* female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
* pregnant or lactating women
* mental or organic disorders which could interfere with giving informed consent or receiving treatments
* Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
* percutaneous biopsy of the primary tumor
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery

Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.

NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with more than one lesion ≧6mm

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease,
* advanced cancer,
* insufficient bowel preparation,
* familial adenomatous polyposis (FAP)
* Lesions ≦ 5mm and submucosal tumor (SMT).
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC

The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.

This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1\~14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.

Eligibility Criteria:
Inclusion Criteria:

1. Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
2. Patients aged between 18 -80 years; with expected survival time\>3 months.
3. Patients with no more than 5 brain metastases
4. Patients with normal organ function within 7 days prior to treatment, the following criteria are met:

   1. blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;

Exclusion Criteria:

1. Patients who had previously used antiangiogenic agents within 1 month;
2. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
3. Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;
4. Patients with cerebral infarction and cerebral hemorrhage;
5. Patients without perilesional edema；
6. Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment.
7. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
8. Patients with visceral dissemination or severe symptoms, which could cause death in short term;
9. Patients with any other severe and/or uncontrolled disease;
10. Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month;
11. Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity;
12. Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism;
13. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
14. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* unilateral primary inguinal repair
* open surgery a.m. Lichtenstein
* informed consent

Exclusion Criteria:

* age below 18 years
* secondary surgery
* laparoscopic surgery
* lack of communicative skills
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).

Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).

The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female, and \> 18 years of age
* Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
* Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
* Patient has agree to participate by giving written informed consent

Exclusion Criteria:

* metastatic pancreatic tumor
* cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
* minor patient under 18 years
* contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
* patient under guardianship
* Pregnant or lactating women
A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct

This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Patient 30 years of age or older
* Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution)
* No evidence of metastases(a)
* decide performe Roux-en-Y(b)
* single Roux-en-Y reconstruction is technically feasible(c)
* Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.
* Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a sngle Roux-en-Y at the time of operation. If a sngle Roux-en-Y is not performed, the patient will not be randomized.
* the surgeon feels that the single Roux-en-Y is not technically feasible at the time of operation,the patients will be excluded. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.

Exclusion Criteria:

* Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)
Bimatoprost for the Treatment of Eyebrow Hypotrichosis

This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).


Eligibility Criteria:
Inclusion Criteria:

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

Exclusion Criteria:

* Patients with disease, infection, or abnormality of the eyebrow area
* Patients with permanent eyebrow loss due to over-grooming
Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery

To compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators designed this study to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* One hundred patients aged above 18-50 years (ASA I or II) scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study.

Exclusion Criteria:

* Absolute or relative contraindications for intrathecal anaesthesia,
* Allergy for the studied drugs.
* Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
* Patients receiving chronic pain treatment or hypertension treated with α methyldopa, clonidine or β adrenergic blockers were excluded from the study.
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening
* intact PTH value ≥ 240 pg/mL at the screening
* Corrected serum calcium ≥ 8.4 mg/dL at the screening

Exclusion Criteria:

* Patients with primary hyperparathyroidism
* Patients who received cinacalcet within 2 weeks prior to the screening
* Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
* Patients who received parathyroidectomy and/or parathyroid intervention
* Patients with uncontrolled hypertension and/or diabetes
* Patients with severe heart disorder
* Patients with severe hepatic disease
* Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening
* Patients who have been judged ineligible to participate in the study by the investigator
Extended-release Sodium Oxybate in Children

The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be under the care of a doctor at the Stanford Sleep Clinic.
2. Participants must have a documented diagnosis of narcolepsy type 1 shown by sleepiness and either: a spinal fluid marker for narcolepsy (hypocretin-1) at a specific level, or a history of sudden loss of muscle control (cataplexy), or a particular genetic marker for narcolepsy, or a sleep study showing a specific sleep pattern for narcolepsy.
3. Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
4. Participants are on a stable dose of medications

Exclusion Criteria:

Participants who have any of the following conditions will not be included in the study

1. Uncontrolled mental health problems
2. Uncontrolled sleep problems that lead to sleepiness.
3. Currently having thought about ending one's life or sadness or loss of interest
4. Currently having a problem with illegal drug use
5. Currently pregnant
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

The study will be conducted in adult participants with Type 2 Diabetes Mellitus (T2DM), receiving standard of care for hyperglycemia and cardiovascular (CV) risk factors, who have either a history of a prior CV event or 2 or more risk factors for a CV event. Participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. Canagliflozin will be provided at a dose of 100 mg/day through Week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose.

The study consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between CANVAS and CANVAS-R. A total of 5,700 participants are targeted to be recruited into the study. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.

The completion target was reached in February 2017.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of type 2 diabetes mellitus
* Must have inadequate diabetes control (as defined by glycosylated hemoglobin level \>=7.0% to \<=10.5% at screening)
* Greater than or equal to (\>=) 30 yrs old with history of cardiovascular (CV) event, or \>= 50 yrs old with high risk of CV events
* Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.

Exclusion Criteria

* History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* History of one or more severe hypoglycemic episode within 6 months before screening
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Ongoing, inadequately controlled thyroid disorder
* Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
* Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.