cyrilzakka/clinical-trials huggingface dataset:
Multi-media Obesity Prevention Program for Adolescents

The objective of this project was to evaluate a population-based, computerized tailored intervention that addresses recommended guidelines for three target behaviors related to obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV viewing (2 hours or less of TV each day).


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* In the 9th, 10th, or 11th grade at baseline

Exclusion Criteria:

-
Does Stellate Ganglion Block Decrease Stress Response of Intubation?

In this study investigators will evaluate the effect of stellate ganglion block on stress response of intubation in comparison to traditional antistress measures in adult patients

Both groups will have the same general anesthesia procedure, patients in stellate block group will receive lidocaine in the stellate block will in control group patients will receive Na.Cl as placebo. primary outcome will be stress response to subsequent endotracheal intubation measure by changes in heart rate

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* General anesthesia with endotracheal intubation
* ASA I/II

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to local anesthetics
* Coagulopathy
* Infection at site of injection
* Patient refusal
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients

The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed Non-GCB DLBCL
2. Age ≥18 and ≤70 years
3. At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)
4. ECOG performance status 0-2
5. Lymphoma International Prognostic Score (IPI) ≥ 2
6. Life expectancy ≥ 6 months
7. Adequate organ and marrow function
8. Agreement to practice birth control from the time of enrollment until the follow-up period of the study

Exclusion Criteria:

1. Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis
2. All patients with primary central nervous system lymphoma
3. History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist
4. Requires treatment with strong /moderate CYP3A inhibitors or inducers
5. Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease
6. HIV infection and/or active hepatitis B or active hepatitis C infection
7. Uncontrolled active systemic infection
8. Known hypersensitivity or contraindications to any drug involved in the study
9. Pregnant or lactating women
Study Evaluating Health Related Utility in Rheumatoid Arthritis

The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.

At a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. The questionnaire will take them about 30 minutes to complete. A blood test may also be required.

This ends the patient's involvement with the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months
* Age 18 years or older
* Ability to complete the study documents in English

Exclusion Criteria:

· Current participation in a blinded trial of an investigational treatment
Clinical Validation of Tele-stethoscope System Digital

Acute respiratory infections and other respiratory and cardiology diseases like COPD or heart failure are important causes of morbidity and mortality around the world. Telemedicine is defined as the delivery of health care and the sharing of medical knoledge over distances using telecommunication systems. Inexpensive techologies offer the possibility of a direct, real-time connection between the patient or the other end. These technologies help to the physicians to manage different symptoms and cardio-respiratory diseases. A real-time wireless tele-stethoscopy system was designed to allow a physician to receive real-time cardio-respiratory sounds from a remote auscultation, as well as video images showing where the technician is placing the stethoscope on the patient´s body. Actually, the lack of physicians in rural areas of developing countries makes difficult their correct diagnosis and treatment. Furthermore, in the majority of health systems, the patients are shared between primary care and medical specialty in hospitals. The tele-stethoscopy system through telemedicine could help to the physicians or health-care technicians in the majority of health systems and especially in rural areas of developing countries without physicians to manage the patients. For this reason, the goal of this project is the clinical validation of an open real-time tele-stethoscope systme (EHAS-Fundatel digital stethoscope) previously designed, with different specialist (pneumologists, cardiologists and internists.)


Eligibility Criteria:
Inclusion Criteria:

* Informed consent sign.
* Pacient admitted to hospital with any disease but no inestable disease.

Exclusion Criteria:

* The lack of informed consent.
* Inestable disease.
Effects of Deep Brain Stimulation of the Dentate Nucleus on Cerebellar Ataxia

Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. The hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients and in these patients, chronic cerebellar stimulation through deep brain stimulation could be a therapeutic option. The rationale is to stimulate the dentate nucleus of the cerebellum in order to balance the functional asymmetry observed between both motor cortices after chronic cerebellar lesions.

Ten patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. The initial focus is vascular and spinal cerebellar ataxias. The participants will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, the participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, the participants will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions. The good responders, i.e., with over than 30% of improvement after the active section will be eligible to bilateral dentate nucleus DBS. After that, again, a cross-over double blind on-off stimulation will be performed. Each period (on or 0ff-stimulation) will last 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of chronic cerebellar ataxia (\> 6 months);
2. Age ≥18 years;
3. Be able to understand study protocol;
4. Signed, written informed consent (approved by the Institutional Ethics Committee) obtained prior to any study procedure;
5. Refractory symptoms response to first, second and third line pharmacological treatment;
6. Daily living activities impaired because the ataxia;
7. Be able to undergo surgery procedures.

Exclusion Criteria:

1. Abuse of alcohol, drugs
2. Known psychiatric conditions
3. Contraindications to DBS
4. Heart failure or cardiac disease that contraindicates surgery procedures;
5. Pacemaker or other stimulators implanted active;
6. Positive blood ß-HCG test for women;
7. Other medical conditions demand hospitalization; Participation in other clinical studies at the same time;
Effects of Metformin on Low Back Pain

The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments

Outcome measures were updated after the initial submission to clinicaltrials.gov. The outcomes were changed in the Institutional Review Board protocol but not updated on clinicaltrials.gov. These outcome measures have since been updated to reflect what was collected for the trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).
* Women of child bearing potential must have a negative serum pregnancy test at baseline.

Exclusion Criteria:

* Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies
* Progressive lower extremity weakness or numbness
* Recent oral steroid use (within last 3 months)
* NSAID use
* Chronic kidney disease (eGFR \<60)
* Diagnosis of diabetes mellitus
* Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
* Unable to take an oral medication in a non crushable pill form
* Taking metformin presently or within the last 6 months
* History of allergy to metformin
* History of lactic acidosis
* Severe Hepatic dysfunction
* Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
* Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
* Currently taking cimetidine
Prevention of Renal Failure in Children With Urinary Tract Infections

The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.

The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.

The 4 phases of the study contain the following questions:

* Phase 1: What is the current clinical management of urinary tract infections in young children in primary care?
* Phase 2: What are the possibilities for improving the clinical management of urinary tract infections and are these improvements practically achievable?
* Phase 3: What is the cost-efficiency of the several interventions for improving clinical management of urinary tract infections
* Phase 4: What is the influence of the intervention on clinical management?

Eligibility Criteria:
Inclusion Criteria:

* children between 0-12 years of age with a proven urinary tract infection in general practice

Exclusion Criteria:

-
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People

The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.

The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.

In the first session:

* Two samples of saliva will be taken
* A video will be made of subjects eating Sponge cake or Brioche
* Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.

During the 6 other sessions, subjects will be asked to:

* Chew one of the study foods and spit it out on the signal of the experimenter.
* Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written consent
* Age ≥ 65 years old
* Persons living at home
* Persons who can travel independently

Exclusion Criteria:

* Adults under guardianship
* Persons without health insurance cover
* Persons in hospital
* Persons in institutions
* Persons whose Mini-Mental State Examination (MMSE) is \< 24
* Persons requiring enteral or parenteral nutrition
* Persons who in the previous 12 months received € 4500 for taking part in clinical trials, including the present study
* Persons in a period of exclusion of a previous study
* Food allergies (cereal products in particular)
An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres

describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic regimen, due to any clinical situation, based on the doctor's routine clinical practice and are currently on treatment with a direct oral anticoagulant (DOAC)


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age diagnosed with NVAF with a risk of stroke or systemic embolism treated in primary care centres.
* Patients on regular treatment with anticoagulants who have changed their ther-apeutic regimen due to any clinical situation and have been on treatment with a DOAC for at least three months before being recruited (date of signing the in-formed consent).
* Patients whose DOAC has been indicated by the primary care physician.
* Patients who have given their informed consent in writing.

Exclusion Criteria:

* Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.
* Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.
* Patients who started anticoagulant therapy for NVAF with a DOAC.
FST-201 In The Treatment of Acute Fungal Otitis Externa

The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of AFOE of in one or both ears, based on a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) and/or 1 for pruritis (absent = 0, present = 1)
* Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
* Provide written informed consent
* Be willing and able to follow all instructions and attend all study visits
* If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.

Exclusion Criteria:

* Have known sensitivity to any component of the study medications
* Have a current infection requiring systemic antimicrobial treatment
* Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
* Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
* Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
* Have used any topical otic treatment within 1 days prior to Visit 1
Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea

The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.

VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)

/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.


Eligibility Criteria:
Inclusion Criteria:

* Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert

Exclusion Criteria:

* There's no exclusion criteria
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy

To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of cerebral palsy. The investigator will proceed the groups during the same period.

1. Demographic Data and Baseline Characteristics of the Studied Group were collected:

   * Basic patient's information survey
   * Medical history
   * Physical examination
   * Basic blood test result
   * Children's developmental disorders evaluation before the treatment
   * Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRI-DTI) before the treatment
   * Neurocognitive function test before the treatment
2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
3. Autologous cord blood doses is 20-30ml (total Mononuclear cells\>1\*10\^7/kg)，the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo.
4. The follow-up: clinical test until 30th month in 3 month gaps.

Eligibility Criteria:
Inclusion Criteria:

* A patient who was diagnosed with a mild case, and severity case of cerebral palsy or developmental disability through developmental assessment from more than two specialists including a specialist in pediatrics and rehabilitation medicine..
* In case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in MRI DTI test.
* A subject who did a written consent to participation in this clinical trial through the very person and a legal representative.

Exclusion Criteria:

* In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial.
* Accompanied by a serious disease, such as chromosome abnormality, etc.
* In case where a patient's medical condition is judged to be maladapted by a researcher.
* In case a patient or his or her legal representative doesn't agree to participation in a clinical trial.
* A patient having a predisposition to allergies.
* A patient having serious disorders in the liver, kidney, and cardiopulmonary function.
Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

Objectives:

To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon

Design:

Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment

Hypothesis:

Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

Eligibility Criteria:
Inclusion Criteria:

* Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
* Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).

Exclusion Criteria:

* History of ocular surgery including corneal refractive surgery
* Compromised zonular integrity or stability
* Uncontrolled diabetes and diabetic retinopathy
* Small pupils
* History of systemic inflammatory disease/uveitis
* History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
* Abnormal liver or renal function