cyrilzakka/clinical-trials huggingface dataset:
Validation of the Turkish Swallowing Disturbance Questionnaire

Purpose of the study is the validity and reliability of the Turkish version of the Swallowing Disturbance Questionnaire (SDQ-T), so that it would be used as an assessment tool for Turkish Parkinson Disease's (PD) patients. Despite being translated and validated in many languages, there is no validated Turkish version of SDQ to measure the severity of dysphagia in PD.

Parkinson's disease (PD) patients who suffered from dysphagia have reported significantly reduced quality of life. The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of dysphagia in PD but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Swallowing Disturbance Questionnaire. The investigators developed the Turkish version of this questionnaire (SDQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SDQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SDQ questionnaire consisted of 15 basic questions related with dysphagia symptoms in PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Able to speak, read, understand and write in Turkish
* Taking food orally
* Malignancy
* Having an active infection
* Advanced demans or

Exclusion Criteria:

* Diagnosed with other neurodegenerative disorders.
* Able not to speak, read, understand and write in Turkish
* Advanced demeans or other cognitive limitations
* Underwent any surgery last six months
* Pregnancy
* Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
* Out of age 18-80 years old.
Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe

The evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. The scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use.

Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions questionnaire ( EQ-5D) were widely validated in various populations, of which the population of the diabetics patients. Both scales have validated versions in French.

In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. One of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations.

Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and Reunion Island, adapting and validating these scales according to an identical procedure in Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French versions of these scales in their populations of type II diabetics patients.


Eligibility Criteria:
Inclusion Criteria:

* male or female ≥ 18 years of age
* type II diabetes diagnosed more than 1 year ago
* creole speaking
* living on the island for more than 5 years
* agreed and signed the informed consent form

Exclusion Criteria:

* not able to understand and follow the instructions
* patients with proven cognitive issues which do not make possible to complete questionnaire
* patients with current acute and serious complications associated with diabetes
* medical history of stroke with physical or neurological damage
* patients already involved in the study
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C

The primary objectives of this study are:

* To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and
* To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.

This is a prospective, multicenter, observational cohort study to assess short and long-term clinical outcomes and immune responses after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and/or Multisystem Inflammatory Syndrome in Children (MIS-C) in children (e.g., defined as individuals who have not reached their 21st birthday at the time of enrollment). SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19)

Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals \<21 years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the United States. The study period of participation is 1 year (12 months).

Eligibility Criteria:
Inclusion Criteria:

1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
2. Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
3. Meets criteria for MIS-C, except has involvement of only 1 organ system

Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed MIS-C.

Exclusion Criteria:

1. Subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent

--Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture

Onlay uretroplasty with either grafts or flaps has been attempted by many reconstructive urologists, ln particular buccal mucosa graft (BMG) ureteroplasty has been reported by many centers and has shown its feasibility and safety

In cases of long segment upper ureteral stricture, more advanced surgical techniques, such as renal mobilization and downward nephropexy, ileal ureter replacement, transureteroureterostomy, and autotransplantation of the kidney, are necessary to provide a tension-free anastomosis.

Autotransplantation of the kidney needs more efforts, more experts and may lead to significant renovascular complications.

Also, there is severe metabolic and intestinal complications are associated with using of long intestinal segment in the management of ureteral stricture \[9\].

These previous side effects and difficulties make the management of long upper and middle ureteral strictures more complicated and indicate other lines of management urgently.

Even the ureteral stricture still not patent enough to drain urine but still, we can use it as a ureteral plate with little affection of its vascularity. Based on this theory an onlay repair technique was emerged.

Onlay uretroplasty with either grafts or flaps has been attempted by many reconstructive urologists, ln particular buccal mucosa graft (BMG) ureteroplasty has been reported by many centers and has shown its feasibility and safety.

Eligibility Criteria:
Inclusion Criteria:

* Proximal ureteral stricture or uretropelvic junction obstruction (UPJO) which are not amenable for primery anastmosis.

Exclusion Criteria:

* Buccal graft contraindications as i. Active oral infections ii.Oral cancers like cancers of lips, tongue or cheeks.
Dissemination of Colorectal Cancer Screening to Primary Care Physicians

The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently repeated educational program, on increasing recommendations for colorectal cancer screening among primary care providers by comparison to a service-as-usual control. The study is a stratified randomized clinical trial of primary care physicians, stratified by distinct urban communities in the New York metropolitan area. The primary outcome is colorectal cancer screening recommendations measured via medical audit at 12-month followup after randomization.

The purpose of the present study is to adapt and extend the use of academic detailing to the dissemination of colorectal cancer (CRC) screening findings and guidelines to primary care physicians practicing in selected geographic areas in New York City. Since improving implementation of cancer screening guidelines also involves compliance by patients in completing the recommended tests or examinations, we will also seek to assess knowledge, attitude and screening behaviors of patients visiting primary care practitioners in our sample. Our long-term goal is to reduce colorectal cancer mortality among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.

The specific aims of the study are as follows:

* Aim 1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician CRC screening at 3and 6month postrandomization, compared to the rate observed in a serviceasusual control.
* Aim 2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of CRC screening guidelines to different physician subgroups.
* Aim 3. To conduct cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the CRC intervention implemented in physicians' offices.

Eligibility Criteria:
Inclusion Criteria:

* Devote at least 50% of their practice to primary care
* Work in the study communities
* Are non-hospital based community practitioners
* Have no immediate plans to retire or to leave their practice.

Exclusion Criteria:

* Specialty physicians
* Intend to retire or otherwise leave practice over course of the study
* Other conditions that would preclude meaningful participation
* Not working in study communities
A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery

Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team).

Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior patient mobilisation within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.

Secondary Objective: To identify whether adductor canal nerve infusions result in superior analgesia within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.

We are comparing a continuous adductor canal block with a low concentration continuous femoral nerve block. We currently use a low dose femoral nerve catheter based technique as part of our standard treatment strategy for total knee arthroplasty. The use of a catheter provides prolonged analgesia compared to a single shot block, and also allows a lower concentration of local anaesthetic to be employed, thus potentially reducing the incidence of motor blockade. The concentration of local anaesthetic employed in our routine practice (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most clinical studies have compared higher concentrations of local anaesthetic - this might be expected to produce more motor blockade. The concentration we use is higher than the minimum effective concentration for a femoral catheter infusion for knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total knee replacement.
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged between 18 and 85 years.
* American Society of Anesthesiologists (ASA) score I-III
* Able (in the clinical staff's opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be noti-fied of participation in the study.

Exclusion Criteria:

* Patient refusal
* Chronic pain (defined as consumption of \>480mg codeine/24hrs or ANY regular strong opiate consumption by the oral/transdermal route)
* Patients aged \<18 or \>85
* ASA score \>III
* Body mass index (BMI) \>35
* Lacking mental capacity to give consent to enter trial/undergo surgery
* Contraindications to catheter placement (coagulopathy , systemic sepsis or infection at placement site, pre-existing neuropathy) or any other component to the study treatment pathway.
* Participant who is terminally ill
* Allergy/intolerance to study medications
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

This study is evaluating the effectiveness of recovery oriented cognitive therapy (CT-R) for patients with schizophrenia/schizoaffective disorder. To evaluate CT-R, the investigators are conducting a randomized controlled trial with patients from community mental health centers. Participants will be randomized to the CT-R condition, in which the participants will receive approximately 9 months of CT-R as an adjunctive treatment to current medical treatment, or to the continued usual care control condition.

The primary outcome measure (positive, negative, and general psychopathology symptoms) as well as secondary measures (quality of life, self-esteem, social anhedonia, recovery, dysfunctional attitudes, resilience, internalized stigma, and hopelessness) will be measured at baseline, 4-5 months after the first therapy appointment, approximately 9 months after the first therapy appointment, and approximately 15 months after the baseline appointment.

Background/Purpose: Despite effective medical treatment, many patients with psychotic illnesses experience poor long-term functional outcomes possibly due to certain psychosocial factors that can interfere with recovery. CT-R was developed to address these factors by leading the individual to substantive progress by addressing any obstacles and promoting a cognitive shift in their beliefs in their own personal and social efficacy. The goal of this study is to evaluate the effectiveness and mechanisms of CT-R as an adjunctive treatment for individuals with schizophrenia/schizoaffective disorder.

Population: Participants will include individuals currently receiving pharmacological treatment for schizophrenia or schizoaffective disorder. Therapist participants who have preliminary training in CT-R will be recruited as well to deliver the treatment. Therapists will first complete a training phase consisting of a workshop and approximately 3 months of group supervision while providing CT-R to 1 training case each.

Intervention: The CT-R that will be implemented in the present study will focus on strengthening aspirations and focusing on activities that can bring about one's desired life. In CT-R, clinicians use techniques to engage the patient in the adaptive mode, which includes cognitions, affects, motivation, and behaviors that are activated when the individual is engaged in personally meaningful activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients: Between 18 and 65 years old with a diagnosis of schizophrenia or schizoaffective disorder, proficient in English, currently under the care of a physician and on medication for schizophrenia/schizoaffective disorder, and able to provide informed consent.
* Therapists: 25 years of age or above, licensed therapist, preliminarily trained in CT-R.

Exclusion Criteria:

* Patients: Medical comorbidities causing brain damage (e.g., stroke, dementia), significant suicidal risk/ideation requiring immediate referral or suicidal gesture.
Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors

The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.

* Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
* Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
* Patients will also receive a mammogram that will be reviewed by study officials.
* Side effects will be monitored every 2 months for one year, between visits to the clinic.
* A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
* A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
* Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.

Eligibility Criteria:
Inclusion Criteria:

* Females diagnosed with Hodgkin's Disease at age \< 35 years
* \> 5 years from mantle or chest radiation
* Current age \> 30 years
* Has completed childbearing
* Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study

Exclusion Criteria:

* History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
* Recurrence of Hodgkin's disease in the 5 years before study entry
* Current participation in any other cancer prevention study
* Current or prior use of tamoxifen
* Current use of coumadin
* History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
* History of cerebrovascular accident
* History of macular degeneration
* Current use of chemotherapy for benign disease
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients

The aim of our study is to identify the incidence of difficult endotracheal intubation in patients with normal BMI undergoing surgery under general anaesthesia in our hospital and compare it to that of obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* BMI\< 30 for Normal BMI group
* BMI \> 30 for Obese group

Exclusion Criteria:

* Known previous difficult airway
* Pediatric patients.
* Emergency patients
PRP vs PRP Plus IGF for Patellar Tendinosis

The purpose of this study is to compare two different platelet-rich plasma (PRP) injections for patellar tendinosis.

Aim: To perform a randomized, double blinded study comparing the clinical effect of PRP versus PRP + concentrated insulin-like growth factor (IGF) in patients with patellar tendinosis.

Introduction/Background:

Patellar tendinosis is a frustrating ailment commonly encountered in sports medicine. Treating this condition continues to be a significant challenge for sports medicine physicians. The tendinosis lesion is characterized by collagen disorganization and increased ground substance. One method of treating this problem is using platelet rich plasma (PRP), which is a concentration of platelets from the patient's own blood that provides a high dose of growth factors aimed at stimulating tendon healing. These injections have been used extensively to treat many tendon disorders including patellar tendinosis. Several studies have demonstrated the safety and efficacy of using PRP to treat patellar tendinosis.

One growth factor that is known to be helpful in tendon healing is insulin-like growth factor (IGF). However, IGF is not found in PRP but rather in the free plasma that is spun off during the PRP processing. This free plasma or platelet poor plasma (PPP) is typically discarded but it is a known source of IGF. We have shown that concentrating PPP in the FDA cleared Plasmax device yields an increased concentration of insulin-like growth factor (IGF). Local IGF injections into the patellar tendon have demonstrated improved tendon healing, but the effect on clinical outcomes has never been studied in a controlled fashion.

Research Design: Double blinded randomized comparative trial.

Detailed Study Procedures: 38 patients will be randomly assigned to a treatment arm. 19 patients will receive platelet rich plasma (PRP) and 19 patients will receive PRP plus concentrated IGF. Patient will be blinded to their treatment, but treatment team will not. PRP will be prepared according to standard sterile procedures out of view of the patient to ensure patients are adequately blinded. The injecting physician will not be blinded to randomization scheme.

Eligibility Criteria:
Inclusion Criteria:

* \>6 weeks of symptomatic patellar tendinosis
* unilateral or bilateral
* 18 yrs of age or older
* active in sport and exercise at least 3x / week
* able to take time away from sport (for healing and rehabilitation phase after procedure)
* failed at least 6 weeks of guided rehabilitation (under the supervision of either a certified athletic trainer or physical therapist)
* minimum Tegner activity level of 4

Exclusion Criteria:

* Steroid injection in target knee in the last 3 months
* PRP in the target knee in the last 6 months
* No other cellular treatments in index knee (bone marrow, amniotic suspensions) last 1 year
* Participation in any experimental device or drug study within 1 year before screening visit
* Oral or IM steroids for last 3 months
* Dry needling of patellar tendon in last 6 months