cyrilzakka/clinical-trials huggingface dataset:
Musical Auditory Stimulation and Exercise

Check the effects of musical auditory stimulation on the autonomic modulation and cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical music can increase recovery velocity after exercise and rock style music can generate a delay in the recovery velocity of the cardiorespiratory parameters and in the cardiac autonomic response.

To implement the experimental protocol, all volunteers were informed to not ingest alcoholic or caffeine-based drinks for 12 hours before the experimental procedure; consuming light meal only two hours before and avoid any vigorous physical exertion 24 hours before the testing.

The experimental procedures were divided into three segments, all performed on a treadmill, with a minimum interval of 48 hours between them in order to allow the volunteers to recover. The protocols running time was always set between 5:30 PM and 9:30 PM, to avoid circadian influences. In addition to these, temperature was fixed between 23 ° C and 24 ° C and humidity between 60% and 70%.

Before the first phase of the experimental protocol the volunteers were approved and the investigators obtained body mass by means of a digital scale (Plenna, TIN 00139 Maxima, Brazil) then height, by means of a stadiometer (ES 2020 - Sanny, Brazil). The comparable stages of the experimental protocol were undertaken:

I) Maximal exercise test: the investigators undertook this to record the maximum velocity (Vmax) reached by the volunteer. This was then applied to indirectly determine the anaerobic threshold via the Conconi threshold. Intensity of 60% of the Vmax obtained in the test was lesser than that found in the anaerobic threshold, and this intensity was enforced to perform subsequent steps;

II) Control Protocol (CP): In this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers.

III) Music Protocol (MP): Volunteers accomplished the same activities of the CP, but with exposure to musical auditory stimulation during exercise and recovery.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* Smokers, alcoholics, subjects with cardiovascular, respiratory and neurological disorders known or other pathological conditions that prevented the achievement of protocols will be excluded from the study.
PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper

This study aims to evaluate the efficacy of lumbar support for low back pain prevention in rubber tapper. The investigators will randomized the participants(rubber tapper) into 2 groups;lumbar support and no support.The participant will be instructed for brace use. The sample size required are 200 subjects with 100 in each group. The subject will be evaluated every 3 month for the incidence of low back pain and quality of life after using the support.


Eligibility Criteria:
Inclusion Criteria:

* current rubber tapper

Exclusion Criteria:

* underlying rheumatologic condition
* previous significant low back pain
* previous back surgery
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
* Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) \>40 International Units Per Liter \[IU/L\]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
* Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
* Have a Psoriasis Area and Severity Index (PASI) greater than or equal to \[\>=\] 12 at screening and at baseline
* Have an involved body surface area (BSA) \>= 10 percent (%) at screening and at baseline

Exclusion Criteria:

* Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
* Has a transplanted organ (with exception of a corneal transplant \>3 months before the first administration of study drug)
* Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
* Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial

This study is a prospective, multicentre, interventional cohort study in children with Prader-Willi Syndrome (PWS) over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years.

Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female child with a genetically confirmed diagnosis of PWS (patients can be enrolled if the genetic subtype is not available at inclusion, but the genetic subtype needs to be confirmed during the study);
2. The parents (or legal representative) must have signed the consent form;
3. Treated cohort: the child participated in the OTBB3 study and is aged 16±4 months at inclusion,
4. Untreated cohort: the child has never received OT, is aged 30±6 months at inclusion (in order to maximise the number of children in the untreated cohort) and is followed in France.

Exclusion Criteria:

1. Administrative problems:

   1. Inability for the parents (or legal representative) to understand/fulfil study requirements;
   2. No coverage by a social security regime;
2. Refusal of parents (or legal representative) to sign the consent form;
Spray vs EMLA Cream on Pain During Intra-articular Injection

All participants are randomly allocated to the spray group, EMLA group and placebo group. In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia. In EMLA group, participants receive an EMLA cream and placebo spray. In placebo group, participants receive a placebo cream and placebo spray.

All participants are randomly allocated to the spray group, EMLA group and placebo group.

In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using ethyl chloride spray (Walter Ritter GmbH and Co., Hamburg, Germany) from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia.

In EMLA group, participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the same scales.

In placebo group, participants receive a placebo cream and placebo spray.

Eligibility Criteria:
Inclusion Criteria:

* Who had a normative schedule of intra-articular injection of shoulder

Exclusion Criteria:

* those who refused to participate, those who were unable to understand a visual analog scale or a Likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, Raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination
A Prospective Study: Tai-chi and Post-COVID Insomnia

The goal of this study is to see if Tai-Chi exercises (a type of Chinese martial arts) can help people suffering from insomnia after COVID-19 when added with cognitive-behavioral therapy (CBT) and drugs compared to CBT and drugs alone. All participants will receive education on sleep hygiene practices, and the principles of cognitive behavioral therapy (CBT). If these approaches were insufficient, they will be given sleep aids, primarily Z-drugs.

All study subjects engaged in a simple Tai Chi training program for two weeks. The Tai Chi training consisted of a series of gentle physical exercises that incorporated elements of meditation, body awareness, imagery, and abdominal breathing.

A professional instructor conducted two training sessions for both patients and controls, ensuring that participants could perform the exercises independently at home during the last hour before sleep. Each session lasted twenty minutes, to be done daily. Participants were given a checklist documenting their sleep and exercise diary to confirm adherence for at least five days each week. After the two-week period, all participants are reassessed using the Insomnia severity index.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infections confirmed by PCR (polymerase chain reaction)
* Over the age of 18 years

Exclusion Criteria:

* Below the age of 18 years
* Severely ill patients
* Patients with chronic respiratory complications
* Individuals with pre-existing and ongoing depression or anxiety
Validity Reliability of The Dubousset Functional Test in Parkinson Disease

In order to achieve collaborative patient-centered rehabilitation in Parkinson's disease, detailed evaluation of walking and balance in evaluating the perceived difficulty in daily life is important to evaluate the progression of the disease and its response to treatments.

In the literature, there are many scales that evaluate balance and functional performance in Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.

Balance disorders are very common in patients with Parkinson's, and these disorders significantly affect the patient's body alignment and participation. Especially during walking, balance disorders occur, resulting in falls, disability and injury in the advanced stage of the disease. As a result of these losses in patients, falls can be seen, and the severity of disability that increases with age affects the quality of life of individuals by affecting their living in their own homes.

Dubousset Functional Test (DFT); A conceptually practical four-component assessment test has been proposed by Dr. Jean Dubousset to assess the functional capacity of adult individuals. The validity of the test was made in individuals with spinal deformity. DFT; It consists of four components: getting up from a chair without arms and walking 5 meters forward and backward, descending and climbing steps, transition from standing to sitting on the ground, and the dual task test in which the individual walks while counting down from 50 at the same time

In the literature, there are many scales that evaluate balance and functional performance in Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.

Eligibility Criteria:
Inclusion Criteria:

Being diagnosed with Parkinson's Disease (Hoehn Yahr level (1-3)

* Volunteering to participate in research and approving the informed consent form Being over the age of 40
* Using stable Parkinson's Disease medication for at least 4 weeks
* No cooperation and communication problems

Exclusion Criteria:

* • Individuals with any other neurological and orthopedic problems Uncontrollable hypertension To your serious disk Significant comorbidity affecting balance and gait

  * Those with cooperation and communication problems
Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
2. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Revision surgery
2. Bilateral knee surgery
3. Age \<18 or \>80
4. BMI \>40
5. Baseline lower extremity strength less than 5/5
6. Vascular calcifications
7. History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
8. Functionally limiting spine disease
9. Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
10. Patients who cannot perform the baseline functional tests
11. Allergy/contraindication to protocol medications
12. Post-traumatic arthritis
13. Inflammatory arthritis
14. Pregnancy
15. Prisoners
16. Patients receiving care as part of a worker's compensable injury
Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease

Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University

Exclusion Criteria:

* (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.
Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors

This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
2. WHO Performance Status of 0-1

Exclusion Criteria:

1. Patients having symptomatic CNS tumor/metastasis and requiring treatment
2. Patients who have received prior therapy with ASA404 or other vascular disrupting agents
3. Patients with systolic BP \> 160mmHg and/or diastolic BP \> 90mmHg
4. Patients with fluid retention
5. Patients with any one of cardiotoxicities
6. Concomitant use of drugs with a risk of prolonging the QT interval
7. Known allergy or hypersensitivity to taxane or polysorbate 80

Other protocol-defined inclusion/exclusion criteria may apply
Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program

This trial is a single-center clinical trial in Taiwan with an expected enrollment of 60 people in Taiwan. The purpose of this trial is to compare the performance of middle-aged and elderly patients with subacute heart failure with that of a healthy control group in terms of balance function and executive function, as well as to investigate whether there is a correlation between balance function and executive function in middle-aged and elderly patients with heart failure and to track the changes in balance and executive function one month and three months after discharge from the hospital. Please think carefully before deciding whether to participate in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with heart failure and receiving post-acute care program for heart failure
* Left ventricular ejection fraction≦40%
* Age ≥ 45
* No cognitive impairment
* Ambulate independently or with the use of aids
* Clinical symptoms are stable
* Voluntary participation

Exclusion Criteria:

* Use of medications that cause dizziness or interfere with balance
* Have other diagnoses that may affect balance, such as stroke, Parkinson's disease
* Color blindness, severe hearing or visual impairment that prevents reading questions and listening to instructions
Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches

The purpose of this study is to evaluate patients with emergency pain and a sore (infected) tooth to determine if immediate root canal therapy is better at reducing pain, when compared to initial treatment with antibiotic and pain medication followed by root canal therapy. Each participant will be randomly assigned a number, which will determine if they will receive initial endodontic treatment that day or at a later date. Each participant will receive an anesthetic injection, pain medication and a prescription for an antibiotic. They will be asked to keep a diary to record their pain level after the injection and their pain levels and the amount and type of pain medication taken each day for the next 5 days. Participants who did not receive root canal therapy at the initial appointment will receive it after the 5 day postoperative period. The pain levels and medication use will be compared between the treatment and nontreatment groups.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* in good health (ASA classification I or II)
* able to give informed consent
* infected tooth with toothache (symptomatic tooth with pulpal necrosis)

Exclusion Criteria:

* allergy to ibuprofen, acetaminophen or codeine
* history of significant medical problems (ASA classification III or greater)
* angioedema or bronchospastic reactivity to aspirin or other NSAIDs
* pregnant or lactating
* inability to give informed consent