cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
* Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
* HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus
Breathing Exercises and Auricular Vagus Nerve Stimulation

Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects.

Methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (Group BE) and vagus stimulation (Group VNS). Thoracic expansion exercise was performed in the BE group. In the VNS group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 Hz, and 20 minutes. Pulmonary function tests were measured on the first and last day. Heart rate, systolic and diastolic blood pressure, RMSSD, PNN50, LF/HF, LF Power, and HF Power values were measured before and after each of the ten sessions for both groups.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18 and 35,
* without orthopedic disability,
* without any chronic disease and regular medication use,
* who had not smoked for the last year,
* who had no problems in reading, writing, or comprehension were included in our study.

Exclusion Criteria:

* active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing
Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit (RPASP)

The primary purpose of the study is to know if foot reflexology can be accepted by patients hospitalized in palliative unit care (assessed by the number of patient who accept to participate), and if it is feasible (assessed by the realization of one session in normal condition : duration of 15-20 min, in supine position/seated or half-seated position).The investigators make the hypothesis that patients will accept to receive foot reflexology, and maybe feel less anxious after one session.

The patients will receive an informative content about the study and will have 24 hours of reflexion. If they accept to participate to the study, they will be randomised in one of the two groups : foot reflexology or "toucher massage" (for those randomised in the "toucher massage" group, a session of foot reflexology will be proposed in a second time). The investigators will assess the level of anxiety, the quality of the sleep and the pain using the ESAS scale, before and after the session. 24 hours after the session, they will be interviewed about what they felt with the session. The investigators will also have a look on the anxiolytic and antagic medication they consume before and after the session.

Eligibility Criteria:
Inclusion Criteria:

* Adult able to give consent, man or woman, hospitalized in palliative care unit, with vigilance criteria from +1 to -3 on the Richmond scale.
* Affiliated to Social Security

Exclusion Criteria:

* Painfull bone metastasis on the feet
* foot amputation
* foot bedsore
* peripheral distal neuropathy, trouble of foot sensibility
* agonic or pre agonic state
* Patients under juridical protection
* Refusal to participate to the study
Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity

The objective of this study was to find if there is a possible association and the impact of epilepsy and epileptiform activity in children with SLI.

This study concentrates on the impact of epileptiform activity for childhood epilepsy on the speech and language disturbances in addition to the associated social, cognitive and intellectual dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* 80 children were suffering from specific language impairment
* 80 healthy children with age and sex match control group.

Exclusion Criteria:

* Previous history of perinatal hypoxic-ischemic damage
* meningitis or encephalitis
* motor weakness
* hearing disorders
* IQ below seventy
* CP, social deprivation
* autism and
* psychiatric disorders .
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV

The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:

1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
2. Separation of bOPV and nOPV2 with an interval of 4 weeks.

Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.

The study will assess whether adding IPV at the end of a 3-dose series of co-administered nOPV2+bOPV achieves at least a 95% seroconversion to all serotypes and whether adding IPV following two doses of co-administered nOPV2+bOPV achieves at least a 90% seroconversion to all poliovirus types.

Study findings will inform vaccination strategies in areas with co-circulation of poliovirus types and provide information about immunogenicity of potential routine immunization schedule with nOPV2 and bOPV in countries with persistent transmission or emergences of cVDPV2.

This is an open-label, controlled, inequality, four arm randomized clinical trial, will be conducted in two study sites in Dhaka, Bangladesh. Participants will be enrolled at 6 weeks of age following inclusion and exclusion criteria's, randomly assigned to one of the four study arms and followed to 18 weeks of age. Three polio vaccines will be used in the study: bOPV, nOPV2 and IPV in different sequential or combination schedules.

Entry evaluations will be completed at 6 weeks of age. Blood collection and study vaccine administration are planned during the study entry evaluation. Post-entry evaluations and follow-up will be done at 10 weeks, 14 weeks and 18 weeks of age. Blood will be collected before any study or EPI vaccines are administered. Presence of poliovirus neutralizing antibodies to all three poliovirus types will be assessed using a microneutralization assay.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants 6 weeks of age
2. Parents that consent for participation in the full length of the study.
3. Parents that can understand and comply with planned study procedures.

Exclusion Criteria:

1. Parents and infants are unable to participate in the full length of the study
2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
3. A diagnosis or suspicion of bleeding disorder
4. Acute diarrhoea, infection, or illness at the time of enrolment
5. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
6. Evidence of a chronic medical condition
7. Receipt of any polio vaccine (OPV or IPV) before enrolment
8. Known allergy/sensitivity or reaction to polio vaccine, or its contents.
9. Infants from multiple births.
10. Infants from premature births (\<37 weeks of gestation).
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

* Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2) with abdominal obesity, based on the following: \*waist circumference \>102 cm if male, \*waist circumference \>88 cm if female
* Is a nonsmoker (has not smoked for at least 6 months prior to the study)
* Consumes a morning and evening meal each day

Exclusion Criteria:

* Is diagnosed with type 2 diabetes
* Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)
* Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with any of the following medications: \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility
* Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting
* Has previously received treatment with recombinant leptin or pramlintide
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient

Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery needs intubation
* ASA I to III
* BMI\>30kg/m2

Exclusion Criteria:

* Head and neck cancer
* Skull, neck fracture
* Tracheal trauma
* NPO\< 8hr
* Lung disease with hypoxemia
* Mental Disorders
* Patient wouldn't be extubated after operation immediately
* Contraindicated to muscle relaxant
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.

The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has given written informed consent
2. Patient is 18 years or older
3. Patient has histologically confirmed prostate cancer
4. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL
5. The prostate size is \>30 cubic centimetres (cc), measured by TRUS
6. Patient has had a bone-scan within 12 weeks before inclusion
7. Patient must be able to undergo transrectal examinations
8. Patient has an estimated life expectancy of at least 12 months

Exclusion Criteria:

1. Any previous treatments for prostate cancer
2. Previous trans-urethral resection of the prostate (TURP)
3. Is not considered a candidate for medical castration
4. Use of urethral catheter
5. Is currently treated with a 5-alpha reductase inhibitor
6. Is currently treated with an alpha-adrenoceptor antagonist
7. Treatment with botulinum toxin A (Botox)
8. Require radiotherapy during the trial
9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
10. Hypersensitivity towards any component of the investigational products or excipients
11. Previous history or presence of another malignancy
12. A clinically significant disorder
13. A corrected QT interval over 450 msec
14. Mental incapacity or language barrier precluding adequate understanding or co-operation
15. Receipt of an investigational drug within the last 28 days proceeding screening
16. Previous participation in any degarelix trial
Efficacy of Inhalation Technique Training.

Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD.

Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.

The aim of the study is:

* to analyze the frequency and type of common mistakes in inhalation technique and
* to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.

Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.

The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.

At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:

A. group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.

Eligibility Criteria:
Inclusion criteria:

* age of 18 - 80 years
* asthma or COPD diagnosed at least 6 months before study enrollment
* everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
* no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)

Exclusion criteria:

* age less than 18 or above 80 years
* lack of informed consent
* asthma or COPD diagnosed less than 6 months prior to screening visit
* coexistence of respiratory diseases other than asthma or COPD
* irregular use (not every day) of at least one inhaled drug
* treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer
Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Meningioma is the most common central nervous system tumor and craniotomy with tumor removal was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can reduce intraoperative blood loss and improve postoperative cognitive function is still inconclusive. So the investigators conduct the randomized control trial to compare the effect of magnesium with placebo control in blood loss and cognitive function in meningioma patient undergoing craniotomy.

The investigators enroll 120 patient who admitted for craniotomy for meningioma removal. Then, the patients will be divided into two groups. The first group or group Mg will receive magnesium sulphate 40 mg/kg infuse for 30 min (started at skin incision), and then infuse magnesium sulphate 10 mg/kg/hr until the dura will be closed. The another group or normal saline group will receive the same amount of 0.9% sodium chloride. The anesthesia and surgery are standardized. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative Montreal cognitive assessment score.

Eligibility Criteria:
Inclusion Criteria:

* Meningioma patient
* Schedule for supratentorial craniotomy with tumor removal
* American society of anesthesiologists physical status 1-3
* Age 18-70 years
* No alteration of conscious (full Glasgow coma score) and well cooperate
* Expected to extubation after operation

Exclusion Criteria:

* Unstable hemodynamic (severe hypotension or hypertension who receive antihypertensive and vasopressor before surgery but not include baseline oral antihypertensive drug)
* Known cardiac disease from either history, physical examination or investigation
* Patient who have heart block
* Hepatic disease (Child Pugh Score Class C)
* Renal insufficiency (eGFR \< 60 ml/min from Chronic Kidney Disease Epidemiology Collaboration equation)
* Allergy to magnesium or other drugs use in the study
* Patient who receive calcium channel blocker drug
* Pregnancy
* Patient who receive magnesium for treatment such as arrhythmia or preeclampsia
* Hypermagnesemia (more than 2.6 mg/dL) before surgery
* BMI more than 30 kg/m2
* Patient who probably have brain herniation from increase intracranial pressure
Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease

The MBD-5D is a prospective observational study with a case-cohort and a cohort design. Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. The study's three goals are (1) to record the patients' characteristics, and variation in the patterns of their treatment; (2) to analyze factors associated with variation in those medical practice patterns; and (3) to identify practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes.

The MBD-5D is a 3-year prospective observational study with a case-cohort and a cohort design. Eligible patients comprise all patients who are receiving hemodialysis at the participating facilities, and who also have secondary hyperparathyroidism(2HPT). The study has 3 goals: to record the characteristics of those patients and variation in the patterns of their treatment; to analyze factors associated with variation in those medical practice patterns; and to identify the practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes. In the case-cohort study, the outcomes are relatively infrequent events (all-cause and cardiovascular mortality). The cohort study includes a randomly selected sample of 40% of all study participants; and the outcomes are hospitalization, parathyroid interventions, bone fracture, MBD management status, etc. Explanatory variables comprise medications and other factors likely to be associated with outcomes of dialysis and of 2HPT, and facility-level practice patterns.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving hemodialysis
* patients whose intact PTH concentration is at least 180 pg/mL (106 pg/mL for whole PTH) OR patients who are receiving intravenous active vitamin D sterols or oral active vitamin D sterols (falecalcitriol)

Exclusion Criteria:

* patients have been undergoing hemodialysis for less than 3 months
Body Perception and Complex Regional Pain Syndrome

In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.

Does a local body image perturbation can affect the balanced of the global self-awareness?

With the investigation of spontaneous sensations (SPS) according to the protocol of Michael and al (2011) the investigators study how patients can listen to their internal sensations located in other body part than the painful member in order to construct a representation of the body and maintain it in active consciousness. A group of controls will be included to understand if there is a global modification in the perception of SPS witch may be linked to the pathology.

Eligibility Criteria:
Inclusion Criteria:

* For patients:

  • a diagnosis of CRPS of the lower limb according to the Budapest Criteria (men or women) For patients and control group
* Age ≥ 18 years

Exclusion Criteria:

For patients and control group

* neurological disease with cerebral repercussion or not stabilized serious physical illness;
* psychotropic medication
* disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

  * For patients:
* Presence of an other pain disorder
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)

This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
* Has measurable disease
* Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
* Is 18 years of age or older
* Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
* Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
* Abuses drugs or alcohol
* Is pregnant or breastfeeding
* Is Human Immunodeficiency Virus (HIV) positive
* Has active viral hepatitis
* Has hearing loss
* Has poorly controlled diabetes mellitus
* Is allergic to gemcitabine, cisplatin or carboplatin
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).


Eligibility Criteria:
Inclusion Criteria:

* Subjects 22 -85 years of age
* Subjects willing to sign the Informed Consent Form and comply with the protocol

Exclusion Criteria

* Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
* Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
* Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
* Condition that does not allow the subject to remain still for 60 seconds at a time
* Subjects with cardiac arrhythmia
* Any known medical condition which may result in an inaccurate measurement using the reference device
* Subjects with the inability to complete an ECG.