cyrilzakka/clinical-trials huggingface dataset:
Shoulder Rating Questionnaire in Turkish

The purpose of this study is to determine the Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and validity in Turkish patients.

Shoulder pain is one of the common musculoskeletal disorders. A self- administered patient-based questionnaire has an important role for evaluate shoulder disabilities and also it is helpful for assess the treatment success.The purpose of this study is to determine the Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and validity in Turkish patients.The Turkish version of the Shoulder Rating Questionnaire (SRQ-T) will be applied to patients after translation from English into Turkish. 122 patients will be participate to the study. Patients who were over 18 years with various shoulder pain complaints will be included into the study. The patients with mixed-type pain, cancer pain, headache, substance abuse, severe depression and fibromyalgia syndrome will be excluded. The musculoskeletal and neurological examinations of the patients will be performed. The Turkish version of the Shoulder Rating Questionnaire (SRQ-T) and Disabilities of arm, shoulder, hands-T (DASH-T) will be applied to all patients.

SRQ-T and DASH-T will be collected in two sessions with at last three days between the sessions for pre-assessment and post-assessment. Reliability of SRQ-T questionnaire will be tested by internal consistency and test-retest reliability. Internal consistency will be evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence interval, ranged between 0 and 1.

To determine the internal consistency of the five domains of SRQ-T, Cronbach's alfa coefficient will be computed for both pre- and post-assessment of the questionnaire. The test-retest method with Wilcoxon Signed Rank Test will be used to determine reliability of SRQ-T and its domains. Then, Spearman correlation coefficients will be used to assess the discriminant validity of SRQ-T for evaluation of shoulder pain. The Spearman correlation coefficient score more than 0.70 will be accepted for reliability

Eligibility Criteria:
Inclusion Criteria:

* Patients who were over 18 years with various shoulder pain complaints

Exclusion Criteria:

* The patients with mixed-type pain, cancer pain, headache, substance abuse, severe depression and fibromyalgia syndrome
Hamstring Viscoelasticity and Low Back Pain

Low back pain (LBP) is a prevalent issue among adolescent rowers, particularly males aged 14 to 16 years, with a high lifetime prevalence (94%) and point prevalence (65%). One of the mechanisms of lower back pain in rowing athletes is about the elasticity, stiffness and tone of the hamstring muscle.

Current literature shows that stretching exercises, strengthening exercises and kinesiotaping affects hamstring viscoelasticity in various ways. Stretching exercises affect hamstring muscle tone and elasticity, strengthening exercises affect muscle stiffness and kinesiotaping affects muscle tone. While the effects of each of these interventions on viscoelastic properties individually are examined in the literature, studies comparing the effects of changes in viscoelastic properties caused by these interventions on low back pain, athletic disability index and athletic performance in rowers and their superiority among each other are lacking.

The goal of this study is to change the viscoelasticity of the hamstring muscles and examine its effect on low back pain, disability index and athletic performance.

Volunteer male elite rowing athletes between the ages of 14 and 18 who score 3/10 or higher on the Numeric Pain Rating Scale at the time of activity will be included in the study. Signed voluntary consent will be obtained from participants and their legal representatives. Participants will be divided into three groups. Study groups will be as follows: a) ballistic hamstring stretching exercise b) hamstring extender exercise c) kinesiotaping

Eligibility Criteria:
Inclusion Criteria:

* Being between ages 14 and 18 and male gender
* Having been rowing at an elite level for at least one year with a professional team
* Having pain 3/10 or higher on NPRS
* Participating to the study in a voluntary basis.

Exclusion Criteria:

* Having limitation in lower extremity range of motion that limits completion of interventions
* Having a musculoskeletal injury involving the lower extremity in the last 6 months.
* Having undergone a operation in the last 6 months.
* Failing to complete any of interventions.
* Wanting to quit from study.
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Eligibility Criteria:
1. Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.

   1. Woman with or without breast cancer or ovarian cancer at baseline.
   2. Man with or without breast cancer at baseline.
2. Signed consent to participation
3. Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion Criteria:

1. A person of legal age subject to a legal protection measure, or unable to express consent.
2. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
Knowledge, Perception, Attitude and Responsibility of Dentists Regarding to Physical Child Abuse in Some Governorates of Upper Egypt

Child abuse and neglect (CAN), child maltreatment, and child victimization are interchangeable terms that refer to a major public health problem confronting children and families. . This study Investigated dentists' level of knowledge, perception, attitude \& responsibility regarding child physical abuse in some of Upper Egypt governorates


Eligibility Criteria:
Inclusion Criteria:

* Dentists who working in Egyptian Ministry of health \&/ or private dental clinics \&/ or centres in three governorates of Upper Egypt (Minia, Assuit \& Sohag).
* Dentists with all dental academic degrees (Bachelor, diploma, master, doctoral \& other post graduate degree).

Exclusion Criteria:

* Dentists who are working in any other governorates except (minia, Assuit \& Sohag).
* Under graduated dental students
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial

This is a updated trial of NCT04188860 as a multi-center study. For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility Criteria:
Inclusion Criteria:

* Female of 18-75 years old
* Eastern Cooperative Oncology Group score 0-1
* Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
* Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
* Anticipative survival period of 3 months or more
* Lab testing within reference ranges
* With appropriate contraception
* Provided consents of participating the trial

Exclusion Criteria:

* With brain metastasis
* With addiction to psychiatric medications or with mental disorders
* With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of \> 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
* With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
* With infective disease which need systematic treatment within 14 days
* With severe open trauma, fracture or major surgery with past 4 weeks
* With potential allergy or intolerance to study regimens
* Not eligible for the study judged by researchers
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women

The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.


Eligibility Criteria:
Key Inclusion Criteria:

* Female (at birth), age ≥ 18 years
* Ability to understand and sign a written informed consent form
* Plasma HIV-1 RNA levels ≥ 500 copies/mL
* No prior use of any approved or investigational antiretroviral drug for any length of time
* Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)
* Normal ECG
* Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
* Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
* Women who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.

Key Exclusion Criteria:

* A new AIDS defining condition diagnosed within the 30 days
* Females receiving drug treatment for Hepatitis C, or females who are anticipated to receive treatment for Hepatitis C during the course of the study
* Females experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Have an implanted defibrillator or pacemaker
* Have an ECG pulse rate interval ≥ 220 msec
* Current alcohol or substance use which may potentially interfere with the female's study compliance
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Participation in any other clinical trial without prior approval
* Any other clinical condition or prior therapy that would make the female unsuitable for the study or unable to comply with the dosing requirements
* Females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice

This is a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.

The present study aims to characterize the use of subcutaneous ofatumumab in a real-world setting. Specifically, the investigation will assess the effectiveness, safety, and treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing forms of multiple sclerosis (RMS) within the Spanish healthcare system.

The study will use primary and secondary data collection. Primary data collection includes information collected using PRO, clinical-reported outcomes (ClinRO), scales or tests and the interview during the study visit. Secondary data collection includes existing data from electronic medical records (EMR) or paper-based medical records, collected as part of the routine follow-up of patients with RMS in the clinical practice.

Baseline will be defined as the date of ofatumumab initiation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years.
2. Written informed consent.
3. Diagnosis of RMS per McDonald Criteria (2017).
4. Ofatumumab treatment in line with the European Kesimpta® summary of product characteristics (SmPC; i.e. adult patients with RMS with active disease defined by clinical or imaging features) during at least 12 months and patients who discontinued ofatumumab after receiving at least one dose with a minimum monitoring of 12 months.

Exclusion Criteria:

1. Currently participating in a clinical trial.
2. Not able/unlikely to complete with all study activities according to investigator's criteria.
3. Have a contraindication for ofatumumab use, according to the SmPC.
Tolerability of Grazax in Patients With Hayfever in Real Life Settings

The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment

Eligibility Criteria:
Inclusion Criteria:

* History of grass pollen allergy
* Positive skin prick-test and/or positive specific IgE to grass

Exclusion Criteria:

* Severe, unstable or uncontrolled asthma (FEV1\<70% of predicted value)
Effect of the Adjunctive IVB Before PRP

This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.

This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured

Eligibility Criteria:
Inclusion Criteria:

* patients with severe NPDR or early PDR without macular edema
* best-corrected visual acuity (BCVA) of 20/25 or better
* patients who were followed up for at least 6 months after the first PRP.

Exclusion Criteria:

* patients with retinal or choroidal diseases except diabetic retinopathy
* contraindications to fluorescein angiography (FA) or bevacizumab
* patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
* patients with previous vitrectomy
* patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.
Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis

compare the outcome of surgical treatment planus by sinus tarsi screw versus conical subtalar screw arthroereisis

Pes planus occurs as a result of loss of the medial longitudinal arch, abduction of the forefoot and excessive subtalar eversion. It can broadly be categorized as rigid or flexible.(1) Flexible pes planus has no single identifiable cause and is often asymptomatic.(1-3) Patients with pesplanus had a very tight achilles tendon due to compensatory motion.(4) It can become painful and may require orthopaedic or pediatric intervention. Common treatment modalities include rest, physiotherapy, orthotics and anti-inflammatories.(1,3,5-6) Surgery is uncommon unless pain persists in spite of nonsurgical management.(5-6) Surgical options include soft tissue procedures, realignment osteotomies and non-fusion motion-limiting techniques.(1,2,6-9) Fusion of selected joints in the foot is not recommended in paediatric patients unless associated with a neuromuscular pathology.(1,5) Subtalar arthroereisis is a recognized non-fusion surgical treatment for symptomatic paediatric flexible pes planus. Arthroereisis (also arthroreisis, arthrorhisis or arthrorisis) derives from Greek, translated as to prop up or support a joint.(10) When Flexible pes planus becomes symptomatic, affecting gait and limiting quality of life, and conservative treatment such as weight reduction, physiotherapy or insoles fail, operative treatment can be considered .(7) There are two techniques for subtalar arthroereisis: (11) Insertion of an implant directly into the sinus tarsi to prevent it collapsing down. (10) Screw insertion into the lateral side of either the talus or calcaneus(12). Calcaneo-stop method with cancellous screw insertion into sinus tarsi for subtalar arthroresis is a valid procedure for this multiplanar deformity. Maintaince of correction of the deformity is achieved via a prioprioceptive mechanism. (13) The current research is the first one to compare the clinical , radiological,and patient satisfaction outcome of planovalgus cases treated with two different types of subtalar arthroereisis implants . The purpose of this prospective study is to show the best technique to achieve patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

- Patients are eligible for participation in the study if

* Patients above the ages of 7years
* All patients with symptomatic pes planus
* flexible flat feet
* Not respond to conservative therapies.

Exclusion Criteria:

* Patients are excluded for participation in the study if

  * Patients were age \< 7 years
  * Asymptomatic patient
  * Rigid flat feet
  * Unfit for surgery
  * Children with neuromuscular diseases, post traumatic or congenital pes planovalgus will be excluded from the study
A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes

The purpose of this study is to compare the amount of RAY1225 that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of RAY1225 will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 7 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥19 kg/m2 and total body weight \>50 kg for male, \>45 kg for female at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption;
10. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Effect of Dietary Cholesterol on Plasma Lipids

The Physicians Committee is carrying out a research study to improve the investigator's understanding and expand the literature to quantify the effect of foods on blood cholesterol. This study will measure changes in low density lipoprotein (LDL) concentration, sometimes called "bad cholesterol," over 2 study periods of 4 weeks each, with 1 rest week in between. Approximately 50 subjects will participate in this study.

In a 9-week double-blind, crossover trial, participants will consume baked goods with either 2 egg yolks or an isocaloric egg-free product daily for 4 weeks. After a one-week washout period, participants will cross to the other dietary intervention. Participants will be asked not to make changes to their exercise patterns or diet, apart from consuming the provided products, for the study period. Changes in LDL cholesterol concentrations will be the primary dependent variable.

Study evaluations, known as health assessments, will be held at the Physicians Committee's office.

Group assignment: After the study entry, will be assigned by chance, like the flip of a coin, to one of two groups. The participant will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. The baked goods will be made from wheat flour with a small amount of sugar, salt, yeast, and other ingredients that are common to baked goods. There will be no animal-derived ingredients, except that some products will contain egg. Each week, the participant will be given a week's worth of baked goods.

Eligibility Criteria:
Inclusion Criteria:

• Following vegan diet for 6 or more months

Exclusion Criteria:

* Following vegan for less than 6 months
* Smoking during the past six months
* Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
* Pregnancy or intention to become pregnant during the study period
* Unstable medical or psychiatric illness
* Lack of English fluency
* Inability or unwillingness to participate in all components of the study
* Egg allergy
* Use of cholesterol-lowering medications