cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD

CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD patients. This study is the first administration in humans.

The study will comprise four parts:

Part 1 will consist of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.

Part 2 will consist of four cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.

Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297

Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect of a repeat dose of CHF6297 after LPS challenge.


Eligibility Criteria:
Inclusion criteria:

Part 1, Part 2, Part 4 (Healthy subjects):

* Male subjects aged 18-55 years;
* Non smokers
* Lung function above 80% of predicted normal value
* Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
* ability to produce an adequate induced sputum sample (study part 4 only)

Part 3 (COPD patients):

* Males and females aged 40-75 years
* Current or past smokers
* stable patients with a post-bronchodilator FEV1 between 40 and 80% of predicted normal value and FEV1/FVC ratio \<0.7
* Ability to produce a spontaneous and an adequate induced sputum sample

Exclusion Criteria:

Parts 1,2, 4 (Healthy subjects):

* Any clinically relevant abnormalities and/or uncontrolled diseases
* Abnormal laboratory values
* Recent respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results
* Positive cotinine, alcohol, drug of abuse tests

Part 3 (COPD patients):

* Females of childbearing potential
* History of asthma
* Unstable concomitant diseases
* Abnormal relevant Holter ECG parameters
* Recent acute exacerbations of COPD or respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results
Predictive Score for Maxillary Osteonecrosis After Invasive Oral Surgery

Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).

Data are collected during the usual follow-up of patients during the first 3 months following surgery.

Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):

* Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
* Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)

The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:

* 1 week after surgery
* 1 month after surgery
* 3 months after surgery

The following information should be noted at each follow-up consultation:

* Appearance of gingival and mucosal tissues : normal or inflammatory physiological state
* Description of possible bone exposure: size, colour, spontaneous or induced bleeding
* Description and assessment of local pain
* Description of a local infection
* Results of a bacteriological sample in case of suppuration

The patient's participation in the study ends:

* at the end of one of the consultations at 1 week and 1 month as soon as osteochimionecrosis of the jaws is diagnosed by the investigating physician
* at the end of the consultation at 3 months otherwise
* in the event of the patient's death during the study
* in the event of the patient's renouncement to participate in the study The patient's participation period is therefore a maximum of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
* Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
* Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
* Patient who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)

Exclusion Criteria:

* History of oral and/or cervico-facial radiotherapy
* Patient treated successively with biphosphonates and then with anti-angiogenic drugs.
* Patient under guardianship, curatorship, or imprisonment
* Patient who has notified his refusal to participate in the research
Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only.

Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.

This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage).

Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs.

This program will focus on uterine cancer (both cervix and corpus).


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Endometrial or cervical cancer

Exclusion Criteria:

-
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

Primary objective:

To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.

Secondary objectives:

To compare the two study groups in

1. Dermatitis quality of life
2. Formula tolerability and acceptability
3. All medically confirmed adverse events

The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and term infants (37-42 weeks gestation);
* Birth weight between 2500g and 4500g;
* 60-120 days of age after birth;
* Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;
* Signed informed consent obtained form the guardian(s) of the infants;
* Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.

Exclusion Criteria:

* Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;
* Evidence of feeding difficulties or intolerance/allergy to cow's milk;
* Conditions requiring infant feedings other than those specified in the protocol;
* Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;
* Acute infection or gastroenteritis at the time of enrollment;
* Participation in other clinical trials at the time of the study;
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Testing New Method of Analyzing MR Images

Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.

The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.

The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.

The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Age 18 years or greater
* Undergoing breast MRI exam

Exclusion Criteria:

* Pregnancy
* Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
* History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality
Nasopharyngeal Carcinoma Screening in Zhongshan City

The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.

The secondary objective is to determine the incidence of NPC in the study population.

The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).

The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.

All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.

Eligibility Criteria:
Inclusion Criteria:

* Subject residents in Zhongshan city
* Subject is 30 to 59 years of age inclusive
* Subject has no medical record of nasopharyngeal carcinoma
* ECOG 0-2
* Subject has psychical condition and well consciousness
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.

Exclusion Criteria:

* Subject has heavy cardiovascular, liver or kidney disease
* Subject has medical record of nasopharyngeal carcinoma
* Subject who is not residing in Zhongshan City
Validation of the Turkish Translation of the London Speech Evaluation Scale

Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.

The speech function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as voice analysis computer programmes, scales, or well structured questionnaires. There are many scales for assessment of perceptual speech but there is no validated for head and neck patients. The study will assess the construct validity and adaptation of the Turkish translation of Speech Specific Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators developed the Turkish translation of this scale (LSE-T), according to the cross-cultural adaptation guidelines. Two translators translated the LSE into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores related with perceptual speech in head and neck cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak, read, understand and write in Turkish
* History of oral, orofarengeal cancer
* Volunteers who accept the informed consent

Exclusion Criteria:

* Mental disorders
* Cognitive limitations
* Able not to speak, read, understand and write in Turkish
* Underwent any surgery last six month
* Permanent tracheostomy, total laryngectomy
* Pregnancy
* Out of age 18-70 years old
* Adults who do not accept the informed consent.
Implanted Drop Foot Stimulator for Hemiparetic Patients

The aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. Therefore, our aim was to further investigate the effects of the implanted system ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.

Patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the AcitGait system (which has a CE-certificate in Europe).

The aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. Patients are assessed before implantation and at one-year follow up. At baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. At follow-up, they are asked to walk with the ActiGait system switched off and switched on.

Outcome assessments include a 10m-walking test and gait analysis with a VICON 3D-camera system. This allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). All outcome data is analyzed using statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* drop foot after stroke, brain haemorrhage or multiple sclerosis
* a minimum of six months after the acute infarction/onset of the disease
* passive extension of the ankle to at least at neutral position
* no sufficient active ankle extension
* free walking without any aid for at least 20 meters in less than 2 minutes
* a walking speed of ≤ 1,2m/sec (measured with 10 meter walking test)
* use of surface electrical stimulation for at least three months
* be able to stand freely

Exclusion Criteria:

* damage to the peripheral nervous system
* epilepsy
* adiposity
* substance abuse
* no cognitive ability to follow the study instructions
* pregnancy
* use of other implanted devices
* instable ankle joint or fixed contracture
Research Online Tele-Rehabilitation Program in People After a Stroke Living at Home

Telerehabilitation refers to the use of Information and Communication Technologies (ICT) to provide rehabilitation services to people remotely in their homes or other environments. By using ICT, patient access to care can be improved and the reach of clinicians can extend beyond the physical walls of a traditional healthcare facility, thus expanding continuity of care to persons with disabling conditions. The concept of telecare, when telerehabilitation is used to deliver services to patients in their homes or other living environments, empowers and enables individuals to take control of the management of their medical needs and interventions by enabling personalized care, choice and personal control Research Goal and Objectives

1. To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab system in post-stroke patients, in their homes.
2. To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's home in terms of:

   1. function of the weak upper extremity
   2. performance of ADL


Eligibility Criteria:
Inclusion Criteria:

* 6-72 months post stroke
* Sitting balance intact (ability to go beyond the midline of the body)
* Moderate impairment of the affected upper extremity determined by range of motion (ROM); shoulder flexion and abduction must be more than 45 degrees with mild to moderate compensations; elbow flexion should be about 45 degrees and trunk movement of about 10 cm.
* Basic ability to independently use the tele-system via touching virtual objects on the screen.
* Having a personal computer (at least Intel i3 processor, with Win7 operating system),Internet access (10MBps) and a large computer monitor (at least 26") at home.
* Caregiver, available when needed, toprovide support throughout the intervention.

Exclusion Criteria:

* Other medical conditions limiting participation in low-intensity exercise training.
* Major receptive aphasia and screening criteria consistent with dementia (Mini-MentalState score \<24).
* Untreated major depression.
* Presence of unilateral spatial neglect as determined by star cancellation (score less than 51).
* Hemianopsia
* Apraxia (limb and ideomotor)
* Other medical conditions that affect the central or peripheral nervous system
* Ataxia
Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a fluid treatment-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* All adults above age 18 who are a member of one of the clinical subpopulations studied in this trial are eligible to participate in the study.

Exclusion Criteria:

* Under age 18
Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China

This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.

Liver resection is one of the most important treatments for hepatocellular carcinoma (HCC). However, only a minority of patients have the opportunity to undergo surgery. The development of systemic therapy has dramatically changed the management of unresectable HCC (uHCC). And lenvatinib garners a recommendation as the primary treatment for uHCC. Many patients with uHCC in Asian countries seek complementary and alternative therapies with traditional Chinese medicine (TCM). However, the impact of lenvatinib combined with CHM on uHCC patients remains unclear. In this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus CHM for patients with uHCC in China.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* histologically confirmed HCC unsuitable for resection
* lenvatinib as first- or second-line therapy

Exclusion Criteria:

* patients with other primary tumors
* patients who had only one visit record and were lost to follow-up or refused follow-up
* patients with any other factors affecting study data collection
Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study

During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.


Eligibility Criteria:
Inclusion Criteria:

* A patient who undergo screening colonoscopy with sedative agents
* A patient over 20 years and under 65 years
* A patient who agree to participate in this study

Exclusion Criteria:

* A patient who is refered from outside hospital to remove previously noted colon polyp
* The case who cannot be achieved cecal intubation because of poor bowel preparation
* A patient who undergo sedative EGD just prior to colonoscopy
* A patient who have allergy to propofol, pethidine, or fentanyl
* A patient who have taken MAO inhibitor regularly
* A patient who underwent colon resection surgery before colonoscopy
* A patient who was diagnosed IBD before colonoscopy
* Pregnant woman
* A patient who cannot maintain sedation level because of significant cardiovascular disease, renal disease, pulmonary disease
* A patient who do not agree to participate in this study
* A patient who cannot understand this study because of foreigner or retarded mental status
* A patient who have lower body weight, less than 37.5kg