cyrilzakka/clinical-trials huggingface dataset:
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent

This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.

In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.

The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.

The secondary outcomes include: Patient satisfaction and Time efficiency.

The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
* Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
* English speaking
* Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)

Exclusion Criteria:

* Patients under the age of 18
* College graduates
* Non-English speaking
* Patient without the capacity to give consent
* Patients with a tactile, mental, visual or auditory disability
Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for TAPS in Breast Cancer Patients

The REaCT TAPS clinical trial will compare a tapering dose of dexamethasone to other standards of care on the presence of taxane-associated pain syndrome (TAPS) in early stage breast cancer.

Taxanes such as docetaxel and paclitaxel are widely used chemotherapeutic agents in patients with early stage breast cancer and is commonly associated with taxane-associated pain syndrome (TAPS). TAPS is characterized by disabling pain which usually starts a few days after taxane administration and lasting 2-5 days, often returning following subsequent chemotherapy treatments. TAPS can significantly reduce a patients quality of life, lead to requirements for potent analgesics, as well as dose reductions/delays or discontinuation of chemotherapy. There is currently no clinical guidelines for the optimal standard of care for the management and prevention of TAPS. This REaCT clinical trial investigates the optimal management of TAPS with a tapering dose of dexamethasone (standard premedication comprising 8mg twice daily for 3 days followed by 4mg once a day for 2 days followed by 2mg once a day for 2 days) compared to other standard of care management (i.e. standard premedication with 8mg dexamethasone twice daily for 3 days) as directed by the treating physician. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving docetaxel-based chemotherapy (Docetaxel 75mg/m2 and cyclophosphamide once every 21 days; or Docetaxel 75mg/m2 and carboplatin and trastuzumab once every 21 days or Fluoro-uracil, epirubicin and cyclophosphamide for 3 cycles once every 21 days, then docetaxel 100mg/m2 once every 21 days; or Adriamycin and cyclophosphamide for 3 cycles, then docetaxel 100mg/m2 once every 21 days) for early stage breast cancer.

  * English literacy and ability to complete questionnaire
  * ≥19 years of age

Exclusion Criteria:

* Contraindication to dexamethasone
* Unable to give informed consent
* Prior receipt of taxane-based chemotherapy
* Patient has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.
Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Through a scientific and standardized multicenter, blinding, double-dummy, randomized controlled, noninferiority clinical trial study method, the investigators evaluated electroacupuncture as a safe and effective non-pharmacological treatment for OAB in women by comparison with Solifenacin Succinate.

Epidemiological researches have shown that approximately 500 million people worldwide are affected by OAB, 2 3 with a higher incidence in women than that in men. Pharmacological treatment remains the usual method of clinical treatment. However, some Pharmacologphy has certain side effects, such as blurred consciousness, dry mouth, constipation, and so on, which have limited its widespread clinical use. Therefore, the treatment of OAB needs comprehensive consideration in clinical practice, which deserves our attention and active exploration of other effective treatment methods to relieve patients' pain.Electroacupuncture can effectively improve the clinical symptoms of OAB. As for the comparison between electroacupuncture and medication for the treatment of OAB in women, the results are inconclusive based on the limited research evidence. The aim of the study is to investigate the effectiveness and safety of electroacupuncture compared to Solifenacin Succinate.

Eligibility Criteria:
Inclusion Criteria:

* Meet the American Urological Association (AUA) diagnostic criteria for adult overactive bladder disorder (non-neurogenic) and the Chinese Urological Association's Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2014 edition) for OAB.
* Female patients aged 18-75 years.
* Duration of illness with OAB ≥ 3 months.
* 3≤OABSS≤11.
* No abnormality in routine urine tests.
* Patients had never received acupuncture treatment.
* No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment.
* Consent to participate in this study and sign a written informed consent.

Exclusion Criteria:

* Combination of more serious heart, liver, kidney and other serious diseases; Or patients with severe liver or kidney insufficiency.
* Patients with pelvic organ prolapse ≥ Ⅱ degree, urinary system surgery history or pelvic floor surgery history.
* Patients with other diseases presenting with OAB symptoms.
* Those with urinary diseases (such as calculi and tuberculosis of the bladder), malignant tumors, and neurological disorders.
* Patients who are pregnant or breastfeeding.
* Patients using medication that may affect bladder function one month prior to enrollment or having received behavioural therapy for OAB three months prior to enrolment, etc.
* Patients with pacemakers.
* Patients with blood diseases, diabetes mellitus or mental diseases.
* Infections, ulcers, abscesses, and skin infections at needling sites; metal allergy or extreme needle phobia.
* Participation in other clinical medical trial studies over the last month.
Comparison the Effect of Smart Phones Addiction Between Children and Adolescents on Posture Deviations , Physical Fitness and Intelligence in Egypt

Comparison the effect of smart phones addiction between children and Adolescents on posture deviations , physical fitness and intelligence in Egypt


Eligibility Criteria:
Inclusion Criteria:

* Subjects with the following criteria will be enrolled in this study :

The participants will be from middle childhood to adolescents and their age will be ranged from 9to 18 years.

They had Body Mass Index (BMI) = 18.5 :40 . They have a score of 24 or more on the Smart phones addiction scale-short version.

Exclusion Criteria:

* Subjects will be excluded from the study if the participant has the followings that affect that study:

visual or hearing defects, cachexia, any neurological disorders and musculoskeletal problems, any congenital abnormalities .
Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes

The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Age : 18 à 65 year
* diabetic patient with a neonatal diabetis (before 1 year old) and need for insuline or patient with a relative having neonatal diabetis

Exclusion Criteria:

Diabète induit (médicaments - ex corticoïdes) ou syndromique

* infection
* cancer
* pegnancy
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome

The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.


Eligibility Criteria:
Inclusion Criteria:

* Wishing pregnancy,
* Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (\> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria),
* Having never been treated with CC (or previous treatment with CC interrupted for \> 3 months).
* Having received complete information and having signed consent.
* Covered by social security

Exclusion Criteria:

* Intolerance to CC in previous treatment,
* BMI \> 35,
* Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),
* Ongoing pregnancy at the time of CC initiation,
* Other male or female cause of hypo-fertility,
* History of ovarian drilling,
* Negative rubella serology.
Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery

This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.

The use of ureteral access sheath (UAS) during Retrograde Intrarenal Surgery (RIRS) has been proven effective and reliable in recent years, and publications indicate that it reduces stone-free rates (SFR). Their use is also recommended in the European Urology Guidelines because it improves image quality, reduces intrarenal pressure, and shortens the operation time. For this reason, it has been routinely used in many RIRS cases. In cases where non-vacuum-assisted UAS is used, fragments during stone fragmentation remain in the kidney, and since it is not possible to remove the stones simultaneously, the image may be distorted, and the operation duration may be prolonged. All these may pave the way for postoperative infectious complications. In addition to non-vacuum-assisted UAS, new UASs with flexible ends and vacuum-assisted aspiration have been introduced in the last few years (ClearPetra). Thanks to the aspiration connected to the system, stone fragments can be removed from the body with negative pressure during stone fragmentation. Continuous circulation prevents bleeding during fragmentation and blurring of the visual field due to stone fragments. In addition, since the stone fragments pass through the edges of the sheath without breaking and are removed, a perfect field of view can be provided. Unlike the classical UAS, the tip is flexible, allowing for the safe removal of lower pole stones. Many studies in the literature compare the success and complications of RIRS in cases where conventional UAS was used and not used. In addition, there are publications related to using the newly introduced aspiration access sheath in percutaneous nephrolithotomy. In retrospective publications on using this UAS in RIRS, it has been shown that stone-free rates, operation time, hemoglobin loss, and postoperative infective complications are more successful on the 1st and 30th postoperative days compared to cases where non-vacuum-assisted UAS was used. There is no randomized controlled prospective publication on this subject. This study aims to compare the complications and stone-free rates of RIRS cases where non-vacuum-assisted UAS and new vacuum-assisted UAS were used.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients below 85 years of age
* Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery

Exclusion Criteria:

* Patients with non-sterile preoperative urine culture
* Patients with renal anatomic anomalies
* Patients with a solitary (single) kidney
* Patients with insufficient data
* Patients under the age of 18, above the age of 85
* Patients without an UAS during RIRS
* Patients without 11-13Fr UAS during RIRS
Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction

The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI).

Cardiogenic shock (CS) is a condition characterized by a severe lack of blood flow to vital organs caused by primary malfunction of the heart, as described by the European Society of Cardiology (ESC) and the American Heart Association (AHA). Acute myocardial infarction (AMI) is a prevalent etiology of CS, constituting a minimum of 30% of the instances. 50% of CS cases manifest upon hospital admission, whereas the remaining 50% occur after hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* Age from 50 to 70 years.
* Both sexes.
* Cardiogenic shock post AMI defined by systolic blood pressure \<90 mm Hg for \>30 minutes or motropes required to maintain a systolic blood pressure \>90 mm Hg in the absence of hypovolemia with signs of pulmonary congestion and signs of impaired organ perfusion defined by at least 1 of the following: altered mental status; cold, clammy skin; urine output \<30 mL/h; or arterial lactate \>2 mmol/L.

  2. Intubated and sedated

Exclusion Criteria:

1. Self-ventilated
2. Indication for targeted temperature management by current guidelines "out of hospital cardiac arrest with return of spontaneous circulation (ROSC)"
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes

A pre-/post-test design. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Decision coaching guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the Decisional Conflict Scale (DCS).

A pre-/post-test design was used. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Eligible participants were youth under 18 years old with T1D and their parents, who were considering a change in insulin delivery method, capable of participating in the decision making process, and able to read and speak English or French. No lower age limit was set for youth participants, provided the youth and parent(s) could participate in the consent or assent process. Family dyads (youth and one parent) and family triads (youth and two parents) were included.

The intervention was decision coaching guided by the Ottawa Decision Support Framework for youth with type 1 diabetes and their parents using a patient decision aid that was pre-populated with evidence on insulin delivery options.

Eligibility Criteria:
Inclusion Criteria:

* Youth with type 1 diabetes and their parents
* considering a change in their insulin delivery method
* capable of participating in the decision making process
* able to read and speak English or French

Exclusion Criteria:

* Using an insulin pump
Surface Treatment of the Dental Implant on the Osseointegration

Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. Recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.


Eligibility Criteria:
Inclusion Criteria:

* Missing mandibular posterior teeth.
* Good oral hygiene (plaque index less than 10 %)
* Good compliance to the treatment.
* Participants are free from local or systemic disease
* Willingness and ability to commit to follow-up placement.
* Adequate bone height and width to accommodate implant placement and sufficient keratinzed mucosa.
* At least 3months after tooth extraction
* Sufficient interocclusal distance

Exclusion criteria

* Presence of persistent and unresolved infection in the implant site
* Parafunctional habits.
* Heavy Smokers.
* Uncontrolled systemic disease that impedes bone healing
This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.

This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.


Eligibility Criteria:
Inclusion Criteria:

* postitive maternal COVID test during the birth
* the newborn was cared at the Semmelweis University after birth
A Trial of Lidocaine Patch for Lower Limb Amputation Pain

Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in particular most persons who undergo limb amputation will experience phantom pain. The neuropathic nature of PLP suggests the involvement of both peripheral and central neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as other central nervous system-related pain syndromes remains a challenge for treatment. Scar hyperalgesia involves peripheral mechanisms and results frim the production of substances liberated by damaged skin cells. These inflammatory substances lower the pain threshold by altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with secondary mechanical hyperalgesia in the skin area around the scar.

The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment of symptomatic postherpetic neuralgia. It also has been successfully used in patients with other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain. The lidocaine patch has not been studied for the management and prevention of phantom limb pain.

The aim of the present research is to investigate if a lidocaine patch 5% is effective for reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent peripheral nociceptive input from the stump after surgery may drive maladaptive cortical reorganization leading to chronic central pain and thus promote chronic phantom limb pain. Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of peripheral nociceptive afferents and thus decrease the likelihood of developing persistent phantom limb pain.

This study is designed as a randomized controlled multicentric double blind trial, in which the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.


Eligibility Criteria:
Inclusion Criteria:

* All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage)

Exclusion Criteria:

* History of central nervous system disease
* History of major psychiatric disease (MMS\<23/30, HADS\>8/21)
* Pregnancy
* Known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
* skin irritation on the stump
Examination of Trends in Non-Small Cell Lung Cancer Patients' Medical Study Experiences

Medical study participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

Participating in an observational clinical trial may help patients with non-small cell lung cancer since it advances medical knowledge and may improve treatment choices in the future.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of non-small cell lung cancer
* Patient has self-identified as planning to enroll in a clinical trial for non-small cell lung cancer
* Patient is at least 18 years of age

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Pregnant or lactating woman
Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

The aims of this study are to determine whether neuromuscular stimulation (NMES) of the quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and staff and whether it can impact clinical and healthcare resource usage outcomes.

.

Patients with IPF who consent to participate in the study will be allocated by chance to use 'active' or 'sham/placebo' NMES for six weeks. Patients will also complete a home exercise programme and receive advice on how to manage breathlessness. Clinical outcomes and trial flow after this six week programme and six weeks after patients have stopped using NMES will be assessed. After this point, healthcare resource use during the study period will be evaluated and interviews involving participants, their carers, and staff about their experiences of the study and using or delivering NMES will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF according to international standards.
* Severe respiratory disability / breathlessness (Medical Research Council dyspnoea score ≥3).
* Able to provide written informed consent.
* Declined or failed to complete a supervised centre-based pulmonary rehabilitation (PR) programme
* Quadriceps maximum voluntary contraction \<80% predicted.

Exclusion Criteria:

* Cardiac pacemaker.
* Co-existing neurological condition.
* Change in medication or exacerbation requiring admission in preceding four weeks.
* Current regular exerciser (structured supervised training ≥3 times per week within last month).
* People who have completed PR in the previous six months.