cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation Study in MS Patients

Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.


Eligibility Criteria:
Inclusion Criteria:

* Female and Male patients aged 18 and more;
* Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
* First indication for Betaferon treatment (as described in Summary of Product Characteristics (SmPC));
* No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
* Walking patients having an Expanded Disability Status Scale (EDSS) score between \> 1 and \</= 4 at the inclusion visit;
* Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
* Patient can follow all the study and comply with all procedures of the trial protocol
* Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential white blood cell \[WBC\]) must be available and the results must be normal;
* Written informed consent.

Exclusion Criteria:

* Any contraindication to Betaferon as described in the SmPC of the product;
* Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
* Patient previously included in this study;
* Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
* Patient previously treated within the past 12 months with Betaferon;
* Participation in any clinical trial within the past 30 days involving the investigational drug intake.
Sense of Hope Alleviates Fatigue in Breast Cancer Survivors

This study explores the relationship between the sense of hope and fatigue in breast cancer survivors and provides a reference for future planning improvements for breast cancer survivors experiencing fatigue.

Breast cancer is an important and escalating issue for females all over the world. Due to the improvement of medical and technological progress, the survival rate of breast cancer patient increases every year. Breast cancer survivors, after the discomforting distress from cancer treatment, will go through treatment-derived physical distress and worry about relapse. As a result the fatigue in breast cancer survivors has not been reduced after primary treatment. Feeling fatigue in a long term will bring mental illness problems ,decrease the quality of life and weaken the will to survive. A sense of hope in the face of fatigue may serve as an important driving force and enhance the survivors' will to survive. This study explores the relationship between the sense of hope and fatigue in breast cancer survivors and provides a reference for future planning improvements for breast cancer survivors experiencing fatigue.

A cross-sectional study design is adopted for this study. The study expects to collect 200 questionnaires from breast cancer survivors through medical centers treating breast cancer and breast cancer patients communities. The questionnaire includes (a) the basic demographic information (b) disease history (c) social support scale; (d) short version multiaxial fatigue syndrome scale; (e) Hearst hope scale.

Answered questionnaires will be input to spreadsheets for further statistical analysis using SPSS 19.0 statistical software packages.

Eligibility Criteria:
Inclusion criteria:

1. diagnosed as a breast cancer patient
2. complete operation,chemotherapy and radiation therapy
3. understand the treatment and condition by herself
4. conscious clear who can speaking Mandarin or: Taiwanese
5. after consenting , the participant agree to participate orally or write down in the consent form

Exclusion criteria:

1. Can not speaking Mandarin or Taiwanese
2. Psychotic or Understanding barriers
3. refuse verbally or write the Consent Form
Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia

The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.

Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.

Eligibility Criteria:
Inclusion Criteria:

* The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal
* Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses
* Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia
* Subjects must be between 8 and 20 years of age

Exclusion Criteria:

* Diopter spherical lenses be \>-3.00 D , or uncorrected distance visual acuity \<0.1, or pathologic myopia with eye complications
* Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia
* The affected eyes have other diseases which affect the determination of acupuncture efficacy
* Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases
* Longterm use of other related drugs or treatments, which have not been terminated
* Parents or subjects refuse to participate this trial
* Participating other ongoing clinical trials
Serbian Smoking Reduction/Cessation Trial (2SRT)

The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Male and female smokers in good general health aged 20-65 years regularly smoking \>10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking

Exclusion Criteria:

* Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition
* History of other significant medical condition that might interfere with study procedures
* Pregnant or nursing mother
* Current drug abuse.
A Registered Cohort Study on Charcot-Marie-Tooth Disease

The aim of the study is to analyze the natural history data data from Charcot-Marie-Tooth disease and related disorders in China, to assess the clinical, genetic, epigenetic features of patients with Charcot-Marie-Tooth disease, and to optimize clinical management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the clinical diagnosis of Charcot-Marie-Tooth disease
* Genetic diagnosis of patients with Charcot-Marie-Tooth disease
* Unrelated healthy controls

Exclusion Criteria:

* Decline to participate.
* Other peripheral neuropathy caused by trauma, immunity and toxicosis.
Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy

Irrigation fluids used during hip arthroscopy surgery are generally stored at room temperature and are cooler than the core temperature of the patient. They are used abundantly during hip arthroscopy surgery. The aim of this study is to detect local and then general hypothermia that may occur by monitoring the body temperature from the rectal mucosa of patients undergoing hip arthroscopy, using irrigation fluids of different temperatures and comparing it with the temperature measured from the temporal region.

This is a prospective randomized controlled study where sequential randomization will be applied to patients; The first patient will be included in the 1st group, and the second patient will be included into the 2nd group, and so on. All patients scheduled for hip arthroscopy in our institution during the defined study period are eligible for inclusion. While room temperature irrigation fluids will be used routinely for Group 1, irrigation fluids heated up to 36-38 degrees will be used for the other group. Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer, whose batteries will be changed every two operations. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined.

Eligibility Criteria:
Inclusion Criteria:

- Patients between the ages of 18-50 undergoing hip arthroscopy and willing to participate

Exclusion Criteria:

* Patients with a previous history of surgery from the same hip
* Patients with a history of thyroid disease (hypo/hyperthyroidism)
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it.

The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

This can be problematic in patients with respiratory failure for which surgical treatment has been challenged. Radiofrequency pulmonary developed as a therapeutic alternative, it has the advantage of being performed in a session with less toxicity in the lung parenchyma

Eligibility Criteria:
Inclusion criteria :

1. Patients over 18 years
2. Histological diagnosis of non-small cell lung tumor established.
3. Stage 1A tumors (lesions \<= 3 cm, N0) report prepared by PET and CT
4. Surgical treatment of the lesion contrindiqué or refused by the patient,
5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)
6. Expectancy greater than 6 months life
7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV\> = 2.5) at the lesion to be treated,
8. Signed informed consent,
9. Patient affiliated to a social security scheme.

Exclusion criteria :

1. Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)
2. Disorder of uncontrolled bleeding (TP \<50% TCA\> 1.5 x control).
3. Abnormal blood count platelets \<90000/mm3
4. Cons-indication to general anesthesia
5. Patient with a cardiac pacemaker if a review indicates treatment against ARF
6. pregnancy
7. Patient included in another clinical study
8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,
9. Private patient freedom and major subject of a measure of legal protection or unable to consent.
Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

This research study is a prospective, single-center, feasibility study designed to assess the possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.

This study is being conducted to evaluate the feasibility to detect hemodynamic changes induced by supra-ventricular or ventricular tachycardia (SVT or VT) using tissue perfusion. Patients with a standard indication for either an electrophysiological study or an implantable cardioverter defibrillators(ICD) implant can be included into this study. Tissue perfusion and arterial blood pressure will be monitored and recorded throughout the electrophysiological procedure or ICD implant testing.

The study will be conducted in two consecutive phases. After completion of study phase I the study phase II will commence. Study phase I will be an acute non-invasive study in patients with an indication for an electrophysiological study, in whom tissue perfusion will be measured non-invasively with an epi-cutaneous tissue perfusion sensor. Phase II will be an acute invasive study in patients with an indication for the implantation of an ICD, in whom the tissue perfusion sensor will be placed in the surgically prepared device pocket on the muscular pectoralis or between the muscular pectoralis major and muscular pectoralis minor.

Eligibility Criteria:
Inclusion Criteria:

* Indication for: an electrophysiological study with ventricular stimulation OR the implantation of an implantable cardioverter defibrillator (ICD)
* Patient is at least 18 years old.
* Patient is able and willing to give informed consent.
A Crowd Sourcing Platform for Patients With Cancer

All4Cure aims to accelerate learning about cancer by sharing medical information and research results from cancer patients with fellow cancer patients, oncologists, and scientists on the All4Cure website with the hope that together patients, clinicians and researchers can cure cancer faster.

The core hypothesis tested by this study is that engaging researchers, clinicians and patients in an online knowledge sharing platform will enable patients to better understand cancer, better inform treatment decisions made by oncologists and accelerate cancer research. Leftover samples from patients with cancer (blood, bodily fluids and/or tissues collected for clinical purposes) will be obtained and sent for various types of analyses and results will be shared on the All4Cure website.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with cancer.
* Be under the care of a physician.
* Be 18 years of age or older.

Exclusion Criteria:
Stress During Deep Sedation With Propofol With and Without Alfentanil

This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.


Eligibility Criteria:
Inclusion Criteria:

* patients who will require deep procedural sedation with propofol in the ED

Exclusion Criteria:

* age \<18
* intoxication
* unable to provide informed consent
* allergy to propofol or alfentanil
* pregnant
* ASA physical status score \> 2
Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years and older.
2. Sex: Male.
3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

1. Institutionalized subjects will not be used.
2. Social Habits:

   1. Use of any tobacco products within 1 year of the start of the study.
   2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
   3. Ingestion of any vitamins or herbal products within the 7 days prior to the initial dose of the study medication.
   4. Any recent, significant change in dietary or exercise habits.
   5. A positive test for any drug included in the urine drug screen.
   6. History of drug and/or alcohol abuse.
3. Medications:

   1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
   2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:

   1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
   2. Acute illness at the time of either the pre-study medical evaluation or dosing.
   3. A positive HIV, hepatitis B, or hepatitis C test.
5. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
   2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to zonisamide or any other sulfa drugs.
9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population

The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease.

Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI.

Secondary objectives:

1. To study the characteristics of different earlobe creases in different gender of the patients with AMI.
2. To analyze the characteristics of earlobe crease in different age groups.
3. To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
4. The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.

Eligibility Criteria:
Inclusion Criteria:

1. Initial acute myocardial infarction(AMI).
2. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin(cTn) with at least one value above the 99th percentile upper reference limit(URL)) and with at least one of the following:

   * Symptoms of ischemia
   * Development of pathologic Q waves in the electrocardiogram (ECG)
   * New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
   * Identification of an intracoronary thrombus by angiography or autopsy
   * Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality.
3. Type 1 (spontaneous myocardial infarction(MI)) in the third universal definition of MI: MI consequent to a pathologic process in the wall of the coronary artery (eg, plaque erosion/rupture, fissuring, or dissection), resulting in intraluminal thrombus.
4. Infarct related artery (IRA) showed that acute thrombus formation, IRA occlusion or stenosis ≥95%、≥90%～95%、≤90%，thrombolysis in myocardial infarction(TIMI) 0-3 flow.
5. Signed informed consent.

Exclusion Criteria:

1. Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.
2. Previous myocardial infarction.
3. Previous percutaneous coronary intervention(PCI) and coronary artery bypass graft(CABG).
4. Chronic total occlusion(CTO)lesions.
5. Ear malformation.
6. Ocular diseases.
7. Participating in a clinical study.
Comparative Study of Two Marketed 1-day Soft Contact Lenses

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Eligibility Criteria:
Inclusion Criteria:

* Has had a self reported oculo-visual examination in the last two years.
* Is able to wear the study lenses for at least eight hours a day, seven days a week
* Aged 18-40 years and has full legal capacity as a volunteer
* Has a distance contact lens prescription from -0.25 and -6.00D inclusive
* Has spectacle astigmatism of \< 1.00D in each eye
* Baseline vision of 20/20 best-corrected in each eye.
* Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
* Has read and understood the consent form and willing to sign consent form
* Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion Criteria:

* Currently wears contact lenses on an extended wear basis.
* Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
* Has undergone anterior ocular surgery
* Is aphakic
* Has never worn contact lenses before
* Has any systemic disease which clinically contraindicates contact lenses
* Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
* Use of systemic or topical medications that will affect ocular health or visual performance
* Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
* Not possible to achieve a satisfactory fit with the lens design used in the study
* Has keratoconus or other corneal irregularity
* Participating in another eye-related clinical trial
* Pregnant, lactating or planning a pregnancy
Endermotherapy With Burn Hypertrophic Scars

Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.

Patients will receive 12 weeks of endermotherapy , 3 times a week.

Eligibility Criteria:
Inclusion Criteria:

* females and males, of any race, 14 years or older,
* a thermal injury,
* at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
* at least 2 scar sites \>2.034 mm thick and within 0.5 mm of each other, and
* signed the informed patient consent form

Exclusion Criteria:

* subjects who have keloids,
* with a diagnosis of psychiatric illness clearly documented in their medical file,
* mechanism of injury is an electrical, chemical, or cold injury,
* a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
* a suspected or known allergy to ultrasound gel,
* unable to understand French or English, or
* subjects who refuse to give informed consent.