cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study

The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial.

The ideal research design to investigate effectiveness of total hip arthroplasty (THA) would be to randomize patients between surgery and (delayed) non-surgery. Such a randomized controlled trial (RCT) is deemed unethical due to the effect size of THA shown in observational studies.

In this study a target trial is specified (a randomized controlled trial between THA and non-THA) and the target trial is emulated using observational data of 2 dutch hospitals participating in the value based health care (VBHC) programme for hip osteoarthritis. The objective of this study is to compare the effect of THA surgery on hip disability and pain between patients that did or did not receive THA surgery during the Covid-19 pandemic. It is hypothesized that THA is effective in restoring hip function and reduction of pain compared to the control group. The effect of THA has not been demonstrated by means of an RCT before. This study can contribute to the available evidence by assessing causal effectiveness of THA by means of RCT target trial emulation.

As a secondary aim, the assumption of pseudo-random group allocation will be assessed. Logistic regression analysis will be used to test whether group allocation is independent of patient characteristics (age, sex, HOOS-PS baseline, NRS baseline, physical therapy before baseline and follow-up time.

Eligibility Criteria:
Inclusion Criteria:

* Patients on the waiting list for primary THA between 1-4-2020 up until 31-3-2022 in OLVG or Martini hospital.
* Completed intake questionnaire (HOOS-PS baseline)
* Indication osteoarthritis of the hip

Exclusion Criteria:

* Patients that received THA on both sides within follow-up (1-4-2020 and 1-1-2022) will be excluded.
* Patients with other indications than osteoarthritis of the hip were excluded.
European New Texture Implant Clinical Experience With Shaped Breast Implants

The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.


Eligibility Criteria:
Inclusion Criteria:

* Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
* Be a candidate for the device styles and sizes available in the study

Exclusion Criteria:

* Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
* Have undergone any previous breast surgery
* Have tissue covering determined inadequate or unsuitable by the surgeon
Comparison of Detection and Miss Rates of Blue Laser Imaging Versus Conventional White Light Colonoscopy

It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal method.comparison of detection and miss rates of BLI group Versus conventional White Light Colonoscopy.

blue laser imaging (BLI) are a new imaging systems used in endoscopy which are recently developed. According to three recently published reports, the diagnostic ability of adenoma characterization using blue laser imaging compares favorably with narrow band imaging. No published data are available to date regarding adenoma detection with blue laser imaging.BLI has the possibility to increase the detection of colorectal polyps by sufficient brightness and clearer endoscopic images.The investigators recruited participants who underwent colonoscopy for symptoms,screening,or surveillance.Participants were randomized for use of either blue laser imaging (BLI) or conventional white light colonoscopy on withdrawal method.Lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates,respectively.The primary outcomes is to compare the adenoma and poly detection rates of BLI with conventional white light Colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients who were underwent colonoscopy in our center for diagnostic work up of colonic symptoms,surveillance of colorectal polyps, and colorectal cancer screening.

Exclusion Criteria:

* history of colon cancer, colectomy familial adenomatous polyposis, or inflammatory bowel diseases;
* severe intestinal stenosis or obstruction;coagulation，disorders;
* pregnancy;
* and colonoscopy examinations with inadequate bowel cleanliness
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II

The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II

Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices.

This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 18 to 90 years, of any race.
* Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)
* Subject with stable (\>3 month) PAD Fontaine Stage II.
* Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (\<30 days) clinical examination
* Subject has intermittent claudication and claudication pain of the calf
* Subject has stable intermittent claudication (\>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade)
* Subject willing to participate as evidenced by signing the written informed consent.
* Treatment with Aspirin or Clopidogrel for at least 7 days
* Willingness to undergo standardized walking exercise

Exclusion Criteria:

* Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.
* Inability to walk
* Chronic respiratory insufficiency (severe obstructive or restrictive)
* Coronary artery disease with angina
* Stroke, myocardial infarction or other acute vascular events in the last 3 months
* Mild-Severe congestive heart failure
* Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking
* Spinal stenosis or disc lesions with lower limb motor sensory defects
* Leg trauma, limb or skin infection or edema
* Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery
* Subject after crural or pedal bypass surgery
* Subject with neuropathy
* Uncontrolled arterial hypertension
* Morbid obesity (BMI \>35.0)
* Need for concomitant medication with potential vascular activity
* Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc)
* Expected weak compliance
* Subject requires surgical or endovascular intervention for PAD
* Subject has known allergy to device components (sleeve fabric).
* Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis).
* Subject participates in any other clinical study at the same time
Dual Task Cost in the Upper Limb in Persons With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults.

Because the lesions are spread in the brains, there is a variety of symptoms. The most common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after 15 years, have problems with movements in one or both upper extremities.

Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although they are less visible, they can have a major determining influence on social or work-related domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of information processing, impaired memory and limited executive functions.

When a combination, of motor and cognitive task, is asked, the execution of these tasks could be difficult with the foregoing in mind. For example problems during chatting while cooking, typing a report at a meeting or watching television while ironing.

The dual-task paradigm assumes that the attention should be divided between two simultaneous tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the separate task versus simultaneously.

Research on dual tasking with persons with MS has already studied extensively, but not specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research on the DTC. They combined the movements of the upper limb with a cognitive task. The research showed a difference between Persons with MS and the control group. At methodological level, there is lacking on the randomization of tasks. That is an important bias because of the learning effect of the tasks. They used only one task for the upper limb; this isn't enough to generalize the concept of motor interference in Persons with MS.

The study has two research questions:

* Have Persons with MS a greater DTC compared with a healthy control group? The motor task is executed with the upper limb.
* Is there a difference on DTC in persons with MS depending on the motor task?

This research is an observational case-control study in which individuals with MS will be compared to a healthy control group. They will be two moments of assessments. On the first day the general performance of the persons will be measured, by using clinical evaluation tests and questionnaires. On the second day they will be tests on the dual tasks, specific a comparison between single versus simultaneously performed tasks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to McDonald's criteria
* 18+
* Have no other neurological or orthopedic disorder of the upper limb or spine. They should have the possibility to actively participate in the research.
* Nine hole peg test, in which the cut-off value is set at 0.5 PEG / sec

Exclusion Criteria:

* Patients are excluded with serious psychological problems.
Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion Criteria:

* Subject has participated or is participating in any other clinical studies of investigational drug or another Investigational Medical Product (IMP) within the last 3 months
* Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Subject has a QTcB (QT interval corrected for Heart Rate \[HR\] using Bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in Electrocardiogram (ECG) at the Eligibility Assessment (EA)
* Subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the Investigational Medical Product (IMP), or/and having an atopic or eczematous Dermatitis, Psoriasis and/or active skin disease
* Subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous Dermatitis, Psoriasis, and/or active skin disease and have a history of suicide attempt, Epilepsy and/or seizures
* Subject has made a blood donation or a comparable blood loss within the last 3 months prior to the Eligibility Assessment (EA)
* Subject is pregnant or nursing
Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China (CHANGE)

Chinese Cardiovascular Association is an association dedicated to establishing Chest Pain Centers in hospitals that have basic qualifications and meet pre-designed quality control targets.The vision of Chinese Cardiovascular Association is the cardiovascular health of every Chinese, and the mission is to realize the early arrival of the inflection point of cardiovascular events in China.The institute of China Heart House is responsible for the daily management and implementation of Chinese Cardiovascular Association and the implementation and management of the Chest Pain Center construction project.In order to improve standard treatment and chest pain system management to achieve better outcomes for patients, China Heart House established the chest pain center database.The database includes patients in 4129 registered hospitals in 31 provinces in China who have been admitted with chest pain.The database can reflect the clinical characteristics, treatment and outcome of patients with chest pain in China.

This non-interventional, retrospective study analyzed the chest pain center database to understand the demographics, clinical characteristics, treatment patterns and clinical outcomes of patients with chest pain, and to analyze the effects of different treatment patterns, including chest pain centers and related collaborative treatment networks.The results of the study will assess the gap between the real-world situation and the recommendations of the guidelines and reflect the effect of chest pain centers and related collaborative treatment networks on the treatment process and service quality.The research results can be directly translated into the basis of medical treatment system intervention, and also provide decision-making reference for improving the certification standards and quality control of chest pain centers.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* patients admitted with chest pain
* diagnosis is made by the treating physician based on local practice and clinical judgment

Exclusion Criteria:

* No
Trial Investigating Efficacy of G-POEM

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.

Study Design The study is a single-centre double-blinded sham-controlled randomized trial. All patients have the same baseline characterization. Patients and researchers will be blinded to allocation in trial. Before randomization patients will have an additional meal test performed addressing metabolic characterization of the incretine hormones at baseline. Patients will afterwards be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied. The study will consist of 5 study visits, with a follow-up of 90 days after procedure. Symptoms and adverse event will be monitored 7, 30, and 90 days after intervention. During the 90-day follow-up all primary and secondary outcome will be reassessed.

G-POEM procedure is carried out in general anaesthesia in the operating theatre at the Department of Surgery, Hvidovre Hospital. Procedures will be performed by experienced surgeons from the Gastro Unit at Hvidovre Hospital,who postoperatively will have no contact with the research team or study participants. Patients will receive the same care during hospitalization.

Patients allocated to sham procedure will have 4 mucosa biopsies from antrum. All biopsies will be handled with formalin and transported to Zealand University Hospital. Here they will be formalin fixed paraffin-embedded and kept in a biobank.

Eligibility Criteria:
Inclusion Criteria:

* The ability to give signed written informed consent,
* Patients with diabetes and gastroparesis,
* Age \>18 years,
* Gastroparesis is diagnosed with technetium-scintigraphy,
* Normal gastroscopy,

Exclusion Criteria:

* Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator,
* Recent gastrointestinal surgery,
* Active duodenal/gastric ulcer disease,
* Diseases in the ventricle or previously complicated upper abdominal surgery,
* Previous bariatric surgery,
* Pregnancy or breastfeeding,
* Parkinson disease,
* Persons who, in the judgement of the investigator, may be unable to follow the protocol, Use of metoclopramide, domperidone, prucalopride, ghrelin, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin) during study period.
* drugs with an anti-cholinergic mechanism,
* Use of motility slowing agents: anticholinergic agents, calcium channel blockers, TCA, GLP-1 analogs, Lithium, diphenhydramin, glucagon, dopamine agonists, progesterone, L-dopa, calcitonine, octreotide, interferon alfa, sucralsulfate,
* botulinum toxin injections (eg, Botox®) by pyloric injection less than 4 months prior to procedure
Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners

Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives:

1. To determine medical characteristics of the disease and the disease process
2. To determine physical and psychological burden on patients as well as economic burden
3. To assess the efficacy and safety of the treatment of the disease


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet at least one of the following:

  1. Documented PHEX gene mutation
  2. Documented PHEX gene mutation in at least one family member with X-linked genetic relationship
  3. Documented FGF23 \>30 pg/mL
* Typical clinical findings of rickets/osteomalacia
* Written informed consent obtained from patients aged \>=18 years or from parents or legally acceptable representatives of patients aged \<18 years

Exclusion Criteria:

* Participation in any clinical study (trial) at the time of informed consent
* Any patient whose participation in the study is considered inappropriate by the investigator or the subinvestigator
Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS)

objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS.

Hypothesis(es) and Aims: Investigators hypothesize that spontaneous exacerbations ("flares") of limb pain caused by CRPS have identifiable and predictable precipitants and timing. The aim of this trial is (1) to aggregate large databases of real-time physiological, psychological, subjective pain, environmental and dietary data and analyze these data with artificial intelligence (AI) to identify temporal precipitants to pain exacerbations, and (2) to identify potential strategies to interrupt the progression of acute pain flares based upon what is learned. Early treatment and strategies to interrupt acute pain flares would have a significant effect on quality of life in this patient population while undergoing treatment and resolution of the ongoing condition.

Design: Design of the study: prospective observational study. Subjects: will be recruited from Stanford's pediatric pain clinic and other like centers nation-wide. Subjects will be issued an Apple Watch and the Medeloop app for data collection. Data collection: Medeloop will collect subjects' electronic medical records (existing and prospective) if subjects sign into the hospital's patient portal through Medeloop.

The Apple Watch will transmit physiologic data to Medeloop in real time for a period of 6 months to derive physiologic parameters from Apple Watch measured pulse rate, oxygen saturation, time in daylight, ECG measurement, and movement/activity. Derived variables include heart rate variability, sleep hours, daily distance walked, right/left weight bearing and gait and others. Using a paired smartphone, subjects will photograph all meals for analysis of the dietary content by AI, which will be transmitted to Medeloop after capture for AI analysis. Medeloop software will use location data and cross-reference corresponding environmental and weather data (e.g., atmospheric conditions, air and water quality) on a daily basis. All pain flares will be recorded in real time via the Medeloop app.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of...

Exclusion Criteria:

-
Transcranial Magnetic Stimulation For Visual Snow Syndrome

This study aims to investigate the feasibility of the use of repetitive transcranial magnetic stimulation (rTMS) for symptoms associated with Visual Snow syndrome (VS).

The study will gather information about the treatment of up to 10 people with VS using rTMS. Treated participants will undergo 10 sessions of rTMS administered 5 times a week over 2 weeks. All visits will take place in the University of Colorado School of Medicine NeuroMag/Transcranial Magnetic Stimulation laboratory on University of Colorado Anschutz Medical Campus.

The specific aims for this feasibility study include:

1. Determine whether any participant experiences untoward effects of rTMS in the setting of visual snow syndrome and determine the potential drop-out rate of larger study.
2. Determine the performance of a novel scale (Colorado Visual Snow Scale) and two three psychophysical visual processing tasks

   1. Determine the standard deviation and test-retest reliability for the novel scale and two visual processing tasks
   2. Determine whether the visual processing tasks perform similar to performance found by the developer
3. Describe changes in outcome measures between pre- and post-treatment with rTMS

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of VS that meets International Headache Society criteria
* Able to provide meaningful informed consent
* Visual snow must be present for more than three months and must be persistent (i.e. continuous)
* A prior clinical Brain MRI with and without contrast done in the past 3 years that does not show signs of clinically significant brain lesions (no evidence of multiple sclerosis, stroke, brain tumor, cortical heterotopia or other cortical developmental abnormalities, arteriovenous malformation, etc...)

Exclusion Criteria:

* Syndrome meeting criteria for Hallucinogen-persisting perception disorder
* Prior treatment with TMS for any disorder
* Epilepsy, family history of epilepsy, or personal history of seizure
* Any medical condition or medication that increases the risk of seizure
* Pacemaker or other implantable medical device
* Metal in the skull, not including the mouth
* Unstable cardiac, pulmonary, or other systemic illness
* Pregnancy
* Bipolar disorder
* History of suicidality