cyrilzakka/clinical-trials huggingface dataset:
Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study

The main objective of this study was to assess changes in the quality of life of patients in a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS) before and one hour after the passage of a clown therapist .

The secondary objectives of this study are to evaluate before versus after the intervention of clowns therapists:

A. Changes in the quality of life at two days after the intervention (using the ESAS).

B. The quality of life two days after the intervention via the McGill Quality of Life Questionnaire.

C. The quality of life of patients after the intervention as assessed by semi-structured interviews conducted by the department psychologist.

D. The quality of life of caregivers after the intervention as assessed by semi-structured interviews conducted by the department psychologist.

E. Employee satisfaction at the end of the intervention period in the department and after debriefing as assessed by semi-structured interviews conducted by the department psychologist.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient receiving palliative care, ie with a severe and progressive disease bringing into play vital prognosis, in advanced or terminal phase
* Clinically stable patients, regardless of disease type. The existence of clinical symptoms (pain, discomfort, etc.) found at recruitment by the investigator and not affecting the mental clarity of the subject, does not justify the exclusion of the patient
* Absence of cognitive disorders; since the protocol provides a clinical interview covering in particular his/her quality of life, included patients will be able to express their feelings
* In addition, patients who have undergone this type of intervention (clown therapist) will not be excluded from this study.

Exclusion Criteria:

* The patient is participating in another study
* The patient is an adult under judicial protection
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient with an inability to fill our protocol assessment scales
* Patients under treatment known to reduce the level of awareness
* Patients with major cognitive impairment
* Patients with symptoms that bring into question their level of awareness
* Patients with significant risk factors and who should benefit from personalized monitoring from the team (clinically unstable patients, emergency situations, agitated patients, dementia, etc ...).
* Patient is unable to submit to the continuity of the study.
Positive Airway Pressure Program

Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.

Over the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence.

This study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
* Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years
* Own a mobile phone, and has reliable mobile network coverage at their home.
* Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload.

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study
Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain

The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain.

Low back pain is a common health problem that can be seen as a symptom and symptom of many diseases in the clinic.

Myofascial release technique is thought to be effective in patients with chronic low back pain. Therefore, when the literature is examined, it has been observed that the myofascial release technique has studies on pain, range of motion, functionality, muscle stiffness and shortness.

This study will be performed on patients with a total of 42 low back pain. The cases will be divided into 2 groups of 21 people by simple random sampling.

Group 1 (control) will be used with sham diaphragm and iliopsoas muscle myofascial release technique and traditional physiotherapy method.

The second group (experiment) will apply the diaphragm and the myofascial release technique of the iliopsoas muscle and the traditional physiotherapy method.

Patients will be treated for 4 weeks. Traditional physiotherapy method will be applied a total of 20 sessions 5 days a week. A total of 12 sessions will be performed, with the myofascial release technique of the diaphragm and iliopsoas muscle applied 3 days a week.

The study focuses on the analysis of the following variables:

Pain : Numerical Pain Scale

Joint Range of Motion: Goniometer

Flexibility: Tape Measure

Pulmonary Function Test: Spirometer

Anxiety and Depression: Beck Depression inventory

Kinesiophobia: Tampa Kinesiophobia Scale

Disability: Roland-Morris Disability Questionnaire

The results of these pre-intervention and post-intervention variables will be compared between the two groups .

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain diagnosed by the physician between the ages of 20-50
* Both genders
* People who have low back pain for 3 months or more
* Persons who have not received physical therapy application for the past 6 months, who have not used analgesics and non-streoids
* Volunteer patients

Exclusion Criteria:

* Having had surgery for the lumbar region or had a surgical diagnosis
* Spondylolisthesis and inflammatory symptoms in the spine
* Pregnant patients
* Other contraindicated conditions determined by the physician:

  1. Those with systemic infections
  2. Those with undiagnosed breathing difficulties
  3. Those with undiagnosed bowel and bladder problems
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).


Eligibility Criteria:
Inclusion Criteria:

1. Provide the singed informed consent form (ICF)
2. Healthy Chinese male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests)
3. Aged ≥18 and ≤45 years
4. Body mass index (BMI) ≥19 and ≤28 kg/m2
5. Weight ≥50 and ≤80 kg
6. Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation
7. Subjects must agree that they and their female spouse/partners will use reliable contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential from the time of the administration of investigational product (IP) until the completion of the study
8. Do not smoke or smoke fewer than 5 cigarettes daily within three months prior to screening; do not drink or drink less than 14 units of alcohol within six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine)

Exclusion Criteria:

1. Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases
2. Clinically significant abnormalities in laboratory test results
3. Previous exposure to any monoclonal antibody or current use of any biologics
4. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients
5. Use of prescription or non prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking IP (whichever is longer). Herbal supplements must be discontinued 28 days prior to the IP
6. History of a blood donation within 3 months prior to the administration of IP
7. Have participated in any other clinical study within 3 months prior to the administration of IP
8. Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies
9. Have a history of drug abuse
10. Unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits or improbability of completing the whole clinical study, etc.
Conventional and Ultrasonic Implant Site Preparation

multi center study with randomized controlled trial design, split mouth

The present study has been designed as a multicenter prospective randomized controlled trial design. Fifteen clinical centers will treat patients by inserting and immediately loading implants with two different surgical protocols. Each patient will receive two identical implants: after randomization, the test site will be prepared by ultrasonic microvibrations and the control site using twist drills. Both implants will be loaded with a provisional crown within 48 hours after surgery. For each inserted implant, collection of experimental parameters will be required up to 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

indications for two implant-supported single crowns with immediate loading in the upper or lower arch (in the incisor, canine or premolar area), based on accurate diagnosis and treatment planning; 2) implants can be in the same or in different quadrants; 3) implant sites must be performed in similar bone quality (i.e. both maxillary or mandibular); 4) the bone crest must be healed (at least three months elapsed after tooth loss); 5) presence of a residual bone crest with an adequate volume to allow the insertion of a 3.8x11.5 mm implant without any kind of regenerative procedure; 6) age of the patient \>18 years; 7) patient willing and fully capable to comply with the study protocol; 8) written informed consent given;

Exclusion Criteria:

1. acute myocardial infarction within the past 2 months;
2. uncontrolled coagulation disorders;
3. uncontrolled diabetes (HBA1c \> 7.5%);
4. radiotherapy to the head/neck district within the past 24 months;
5. immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
6. present or past treatment with intravenous bisphosphonates;
7. psychological or psychiatric problems;
8. alcohol or drugs abuse Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease (full mouth plaque score and full mouth bleeding score \> 25%)
The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain

The aim of this study was to compare the effectiveness of Cognitive Functional Therapy compared with Conventional Therapy in treating adults with chronic neck pain

After being informed about the study and potential risks, all patients giving written informer consent will undergo 1 week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility criteria will be randomized in a single- blind manner (assessor), in a 1:1 ration to cognitive functional therapy or conventional therapy twice a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Pain in neck area for more than 3 months
* Pain in NPRS more than 40/100
* Independently mobile (with or without aids), to be capable of participating in a rehabilitation program twice a week

Exclusion Criteria:

* Serious psychological pathology
* recently surgery on shoulder or neck area (\<6 months)
* Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
* Pregnancy
* Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
* Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
* Unstable cardiac conditions
* Red flag disorders like malignancy/cancer, acute traumas like fracture (\<6 months ago) or infection, spinal cord compression/cauda equina
The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience

Background: This study planned to investigate the effect of early physiotherapy on biochemical parameters in major burn patients.

Methods: Ten women (50%) and 10 men (50%) aged 21-47 years old were included in our study. Participants were divided into two groups: one group was the treatment group and the other was the control group. In the treatment group, patients were admitted to the physiotherapy programme from the first day they have been hospitalised, in addition to their routine treatment (medical, surgery, etc.), for 4 days per week. It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises. The days of treatment were determined as Tuesday, Wednesday, Thursday and Friday. Patients could not be treated on a Monday because that was surgery day. The control group consisted of patients who could not receive physiotherapy due to various reasons. All patients included in the study were evaluated weekly for 6 weeks after admission to the hospital. Parameters such as demographic information, characteristics of burn injury, C-reactive protein, fibronectin, transferrin and prealbumin were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Major burn injury (according to ABA)
* Conscious patients

Exclusion Criteria:

* Inhalation injury
* Various chronic disorders
* Organ dysfunctions
A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers

The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests
* Body weight (at screening); female ≥40.0 kg, \<70.0 kg, male ≥50.0 kg, \<80.0 kg
* BMI (at screening): ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening test
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening test
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
Muscular Respiratory Involvement and Systemic Sclerosis

Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability.

Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors.

Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT).

This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years-old
* ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital
* Written informatory consent

Exclusion Criteria:

* Individuals under tutorship or guardianship
* Individuals with reinforced protection: minors, judiciary or administrative decision
* No affiliation to social insurance
* Pregnancy or breastfeeding
* Associated neuromuscular disease (myasthenia, degenerative diseases)
* Bedridden individuals or with health condition not allowing realization or interpretation of PFT and/or EMG (acute cardiac and/or respiratory failure, pneumopathy)
* Individuals with pacemaker and implanted pumps, especially sensing dispositives, as defibrillators ( relative contre-indication to EMG with magnetic stimulation)
* Individuals with contre-indication to gastroesophageal probe: INR \>4, oesophageal varices, suspected cardio-facial fracture, oesophageal and/or facial obstacle
Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis

Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects. The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient reported and economic outcomes.

This was a single center 10-year randomized controlled clinical trial. 50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant or a tooth supported fixed partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly. Survival, complication free survival, recurrence analysis, oral health related quality of life and patient reported outcomes analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Non-smokers or smokers with less than 20/day
* Good oral hygiene (FMPS\<25%)
* Good control of periodontitis (FMBS\<25%)
* Good compliance with treatment
* Presence of generalised stage III or IV periodontitis
* Radiographic bone loss to the apex or beyond the apex of the root at at least one interdental aspect
* Presence of severe clinical attachment level loss (\>10 mm)
* Presence of clearly identifiable crest of bone in adjacent teeth
* Lack of function due to hyper mobility
* Vital or non-vital teeth

Exclusion Criteria:

* Medical contraindication to elective surgery
* Poor oral hygiene
* Incomplete control of periodontitis in the dentition
* Inadequate compliance
* Inability to provide informed consent
A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2

The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

The subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US).

This study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 \[V10\]) to Week 52 (Visit 16 \[V16\]), and using the same sites.

Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Eligibility Criteria:
Inclusion Criteria:

* Subject completed V10 of the original study (ZRHR-ERS-09-US).
* The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.
* Subject has given written informed consent to enter the 26-week extension study at V10.

Exclusion Criteria:

* Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
* As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
* Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
* Female subject is pregnant or breast feeding.
* Female subject who does not agree to use an acceptable method of effective contraception.