cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation Based on Aerobic Exercise in Fibromyalgia

Fibromyalgia syndrome is the most common cause of chronic generalized musculoskeletal pain and is characterized by pain associated with generalizad sensitivity, fatigue, sleep disturbances and psychological problems. Due to the chronic nature of the pathology and the great dependence on analgesic drugs that it often entails, in these patients it is considered necessary to provide an individualized approach and provide strategies that allow symptoms to be controlled conservatively and non-pharmacologically.

The objective of this trial is to analyse the immediate effects on pain, mechanical pain sensitivity, impact of fibromyalgia, pain catastrophizing, psychological distress and physical function when a telerehabilitation program based on aerobic exercise is applied in women with fibromyalgia.

For this purpose the investigators conduct a randomized controlled trial single-blind (examiner). The investigators included female patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Thirty-four women with fibromyalgia are included and randomized into 2 groups: telerehabilitation program group based on aerobic exercise and control group. Exercise group receive 2 treatment sessions a week over 15 weeks.

All the variables are measured at the beginning of intervention and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed medically with Fibromyalgia
* Diagnosed according to the American College of Rheumatology criteria
* Age between 30 and 75 years old
* Telerehabilitation equipment including a laptop computer and access to internet

Exclusion Criteria:

* Any kind of contraindications for physical activity
* Other physical or psychological therapies in the last 3 months.
* Medication modifications in the last 3 months
An Evaluation of the Ability to Train Established Glaucoma Patients Who Have Difficulty in Drop Instillation

This is a prospective, observational, single-center study. Patients with at least 3 months of experience using topical medications for glaucoma and who state that they administer their own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial eye drop, will be identified at the time of a regularly scheduled exam. If the patient can get a drop onto the eye and also not touch their lids or ocular surface with the eye drop bottle, the subject will be thanked but not enrolled. All other patients who agree to participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each enrolled patient will be shown a video demonstrating an instillation technique and will be given an instructional handout highlighting a proper drop instillation technique. If necessary, an instillation technique will be demonstrated to them by an investigator or trained personnel.

A patient will be identified as properly instilling a drop if they satisfy the following criteia:

They are able to instill one (and only one) drop to the ocular surface or lower fornix without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.

All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the investigator or trained personnel would direct the patient to instill an eye drop into the study eye.Additionally, the short glaucoma self-efficacy questionnaire will be re-administered.

All of the video-recordings of participants' eye drop instillation techniques will be reviewed and assessed using a standard checklist. Their ability to administer an eye drop after training will be compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients currently using topical ocular antihypertensive medications at the time of enrollment in at least one eye, and who have been using these drops consistently for a period of at least three months prior to enrollment.
* Patients with primary open angle glaucoma, pigmentary glaucoma, exfoliation glaucoma, ocular hypertension, normal-tension glaucoma, neovascular glaucoma, uveitic glaucoma and chronic narrow angle glaucoma.
* Patients CAN be enrolled even if they have co-existing morbidities such as Parkinson's Disease or arthritis

Exclusion Criteria:

* Patients who do not instill their own eye drops
* Patients who are not expected to still be using topical antihypertensive medications at the time of study follow-up
* Patients with no light perception vision
* Patients with a history of adverse reaction to artificial tears or any component of artificial tears
* Patients who have a typical follow-up period of greater than 6 months
* Patients who have not completed a Humphrey Visual Field C24-2 or C10-2 within 7 months of enrollment or study exit.
Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed Male \& female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1. Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the investigator, to understand and comply with the study requirements.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.

Subjects that were previously treated for HCV infection.
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)

Exclusion Criteria:

* Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
* Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated

Other protocol defined inclusion/exclusion criteria could apply
Comparison of Arch Expansion Changes Between Passive Self-ligating and Conventional Brackets

The purpose of this randomized controlled clinical trial was to compare the transverse development of the arches and the incisor inclination comparing two different ligating systems (SL vs CL) with the same arch form protocol (Damon arch form) and the same disarticulation protocols after the alignment and leveling period of non-extraction patients.

Materials and Methods: Fifty-four subjects were randomly with an electronic randomization program allocated to treatment with either a self-ligating bracket system (Damon Q-slot 0.022", Ormco Corp,) or a conventional bracket system (Orthos-slot 0.022", Ormco Corp). All patients were treated following the same protocol and arch wire sequence: 0.014-inch, 0.018-inch and 0.014x0.025-inch Damon copper nickel-titanium arch wires (Cu-NiTi; Ormco). Lateral cephalograms and study models, taken at prior to treatment (T0) and after alignment and levelling (T1), were used to compare the amount of arch expansion and incisor angulation changes that took place. In the analysis of results in a single observer analyzes the data blindly without knowing which group the patients belonged. Results: Models and cephalograms of the patients and both stages(T0-T1) were measured at the data were analyzed in STATA S.E. Treatment produce statistically significant increases in transverse arch dimensions especially in premolars maxillary (2.8-4.3mm) and mandibullary (2.0-4.2mm) of both group. The expansion in the maxillary arch was similar for both groups, but in the mandibular arch was greater in the self ligation group in about 2 mm more. Conclusions: The treatment with self ligation brackets produced more expansion in the mandibular arch than the conventional ligation brackets when used the same arch Damon protocols.

Eligibility Criteria:
Inclusion Criteria:

1. ANB angle between 0º- 5º
2. Systemically and periodontally healthy subjects not taking any medications.
3. Maxillary and/or mandibular irregularity index (canine-to-canine) between mild to moderate
4. A non-extraction treatment approach.
5. Permanent dentition with second molars erupted or in a functional eruptive phase.

Exclusion Criteria:

1. Systemically and periodontally compromise subjects and taking any medications. (2 ) subjects who did not want participate in the investigation
Effect of UHT Treated Milk on Blolipid Profile

The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* 22-50 years of age
* BMI 25-30
* non smokers

Exclusion Criteria:

* lactose intolerance
* milk allergy or other types of food allergy
* Intestinal, abdominal or endocrinnologic diseases
* daily use of dietary supplements incl. vitamins and minerals
* cronic diseases (diabetes, CVD etc.)
* user of medicin on perscription that can influence the resuts of the study
* allergic to paraamino benzoe acid
* Physical activity \> 10 h pr week
* Blood donor
* on a diet or change of dietary habits within 3 months
* body weigh change \> 3 kg within the last 3 month
* special diets
* concomitant participation on other studies
* not able to comply with protocol
A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test

WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.


Eligibility Criteria:
Inclusion Criteria:

* Participant is an adult (according to the age of majority as defined by local regulations)
* Participant is currently diagnosed with any type of solid tumour cancer, at any stage of the disease, at the enrollment date (informed consent date)
* Participant has undergone NGS testing, no longer than 3 months prior to the enrollment date, irrespective of the availability of test results
* Informed consent has been obtained from the participant or legally authorized representative, as per local regulations

Exclusion Criteria:

-Participant has a prior or current diagnosis of haematological malignancy
School-based Comprehensive Suicide Intervention in Shanghai, China

The primary aim of this study is to examine whether a school-based suicide intervention is effective in reducing suicide related risk factors in a population of middle and high students. It hypothesized that receiving the intervention will reduce the severity of suicide related risk factors such as depression, hopelessness, suicidal behaviors and increasing protective factors such as social support, self esteem, suicide knowledge and attitude and so on, as compared to the control group.

A total of 3000 students from two junior schools (grade 7 and 8) and two senior schools (grade 10 and 11) in Shanghai Pu Dong district were recruited in our study. All students were randomly assigned into universal study group or universal control group by class level. In those two groups, high risk of suicidal students were identified by screening. A universal suicide intervention was conducted in the universal study group; an indicated suicide intervention was conducted in the indicated study group. All students in universal study group and universal control group completed the self-administered questionnaire before and 6 months after the end of universal intervention. High risk of suicidal students in the indicated study group and indicated control group completed another self-administered questionnaire before, 6 months and 18 months after the end of the indicated intervention.

Eligibility Criteria:
Inclusion Criteria:

* students of grade 6,7,9,10 from four schools (2 middle schools, 2 high schools)

Exclusion Criteria:

* students who are not attending school because of long term sickness or moving to other school,or going aboard, etc.
* students whose parents don't agree to participate the study
Real-Life Study in Diabetic Macular Edema

The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.

The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema treated with intravitreal anti-VEGF injection
* Having at least 4 or more annual examination visits

Exclusion Criteria:

* Phacoemulsification surgery in the last 1 month
* PRFK / grid / focal / micropulse in the last 4 months
* Previous intraocular surgery (excluding PPV and phacoemulsification)
Impact of Simulation Training for Obstetrics-gynecology Residents.

The main objective of the study is to evaluate the benefit of simulator training for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction \[VE\]) for obstetrics-gynecology residents.

The primary outcome of this randomized control trial is to evaluate the impact of simulation training on the success of ECV and VE.

Usually, the training of obstetrical maneuvers are done "one the job" according to the situations encountered in the clinical practice during postgraduate training. This has some disadvantages like inequality of exposure to these situations, inadequate learning environment (emergencies, impossibility to repeat the maneuver, etc.) and risk complications related to the learner'slack of experience. To evaluate the benefit for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction \[VE\]), the investigators are conducting a randomized control trial composed by two parallel studies. Each group will represent the control group in relation to the maneuver to which it will not be trained.

The objectives of the first one is to evaluate the impact of simulation training on the success of ECV, the complication rate, as well as the patient's and learner's satisfaction. The objectives of the second one is to evaluate the impact of simulation training on the success of VE, the complication rate, as well as the patient's and learner's satisfaction.

The overall goal is to evaluate the effects on clinically relevant outcomes of the teaching by simulation in obstetrics. If simulation training improves the success rate of these maneuvers and the satisfaction of the patient and the learner, simulation learning will be included in a formal and systematic way during postgraduate training in obstetrics.

The subjects are the resident doctors or consultants who have had no or few prior simulation training (maximum 1 session) and little clinical experience of the maneuver evaluated (maximum of 19 of each maneuver).

Eligibility Criteria:
Inclusion Criteria:

* Being a resident or consultant working in the gynecology and obstetrics department of the hospital
* Agreeing to participate in the study by signing an informed consent form

Exclusion Criteria:

* Having performed several ECV or VE simulation training (more than 1 session each) before the recruitment
* Having already performed more than 20 ECV and more than 20 VE during clinical practice before recruitment.
* Having a planned clinical activity in the delivery room which does not allow to perform at least 1 ECV or 1 VE during the study period.
A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE

Importance: Less than fifty percent of patients with hypertensive disease manage to maintain their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models are needed in order to improve BP management in patients with hypertension.

Objective: To evaluate whether cloud BP system integrated with computerized physician order entry (CPOE) is useful for improving BP management as compared with traditional care.

Design, Setting and Patients: A randomized clinical trial study of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan. Physicians had access to cloud-based BP data from CPOE. Neither participants nor investigators were blinded to group assignment. The study was conducted for a period of seven months.

Interventions: Patients from two hospitals were randomized into a control group which received traditional care (n=212) and an intervention group (n=170) which received a cloud-based home BP monitoring device. The device measured and transmitted BP data to the cloud server, which was integrated with the CPOE system in the hospitals. Physicians could access the BP data during the patient encounter to adjust the antihypertensive therapy accordingly. Meanwhile, patients could browse their own BP data from their computers, smart phones, tablets and so on.

Primary Outcome(s) and Measure(s): The primary outcomes were control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg at two, four and six months. The secondary outcomes were changes in BP and antihypertensive drug prescription at two, four and six months.

Eligibility Criteria:
Inclusion Criteria:

* Secondary hypertension
* Expectant mother
* Stroke, myocardial infarction or had surgery within 3 months
* Atrial fibrillation
* Inter-arm difference (IAD) \>20 mm Hg
* Unsuitability as recognized by physicians.

Exclusion Criteria:

* Unable to participate in this trial for the whole process
* Lived alone and unable to read Text Message
Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach

Patients and parents of patients will be asked to answer a questionnaire on paper or online, by the CRCMs and through communication campaigns distributed by the association Vaincre La Mucoviscidose (VLM).

This questionnaire includes about fifty items that will take 5 to 12 minutes to complete. The study aims to interview 250 patients / parents of patients, users and non-users of essential oils.

Thirty patients or volunteer parents will then meet with a health anthropologist for qualitative interviews to document very precisely the modalities of use of essential oils: which ones, at what dose, advised by whom, the dedicated budget. Relationships with CRCM doctors, the effects felt, the side effects will also be explored.

The global data of the two phases will be integrated and put into perspective with the scientific data currently available on essential oils.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patient or parent of a child with cystic fibrosis

Exclusion Criteria:

* patient who refused
Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor

To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Eligibility Criteria:
Inclusion Criteria:

* 1.woman, age \> 18 years old 2.Diagnosed with HR+/HER2- Metastatic Breast Cancer 3.Patients received tucidinostat-based therapy after progression on CDK4/6 inhibitor 4.Complete medical history was available

Exclusion Criteria:

* 1.Medical history was incomplete
Multimodal Analgesia Effect on Post Surgical Patient

Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed

Pain control after weight loss surgery is challenging due to the alteration of digestive system anatomy and limitation on using medications which can either be crushed or in liquid form for the first 10 days to 14 days after surgery. Additionally there are multiple programs in place to eliminate the use of narcotic/opioid based pain medications due their potential addictive risks.

This study compares two groups of patients whom will have Roux en Y Gastric Bypass Surgery at UC Davis Medical Center, the control group will receive standard of care pain control medications (including opioid based medications) compared to the research arm, this group will receive Gabapentinin and Tylenol for pain control after surgery with rescue pain medications available if needed.

Post surgery both groups will be managed by the Bariatric Surgery Team and will be contacted periodically as part of the standard of care to monitor pain control and usage of any rescue medications (if needed).

Eligibility Criteria:
Inclusion Criteria:

* Women who undergo index weight loss procedures at UC Davis Medical Center
* Women with a BMI =\>30
* Age from 35-65
* American Society of Anesthesiology (ASA) score of 3 or less
* No previous history of prior abdominal/foregut surgery

Exclusion Criteria:

* Not having an index weight los surgery for obesity
* Do not meet the NIH Standards for weight loss surgery
* Additional planned or unplanned procedures during the index surgical procedure such as Cholecystectomy or extensive lysis of adhesions (\>30 minutes)
* BMI \< 30
* Men
* Women considering or currently planning on gender altering/modification
* ASA score of 4 or higher
* Patients less than 35 years of age or older than 65 years of age at the time of surgical consent
* A history of open abdominal surgery including umbilical, ventral, or splengalic hernia repair with or without mesh implantation, transplant or vascular surgery or any foregut procedures including hiatal hernia repair or anti-reflux surgery
* Arthritis, Fibromyalgia, chronic pain syndrome
* Other conditions requiring daily use of oral pain medications
* Prisoners
* Allergy to Gabapentin