cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.

The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)
* Patients treated with injectable bone antiresorptive therapy for 12 months or more
* Signed written informed consent

Exclusion Criteria:

* patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries
* patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women
Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors

Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. \[1\] The less frequently encountered IDEM tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.\[2\] Spinal cord tumors can cause different signs and symptoms, especially as tumors grow. The tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. Signs and symptoms may include: Pain at the site of the tumor due to tumor growth Back pain, often radiating to other parts of body Feeling less sensitive to pain, heat and cold Loss of bowel or bladder function Difficulty walking, muscle weakness .

MRI is the investigation of choice,however other investigation such CT or X ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.\[3,4\] Over the years, there has been no significant change in the clinical symptoms and pathology of IDEM tumors. However, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. Despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of IDEM tumors continues to be significant \[5,6\].

Here, we examined the surgical outcomes of 20 patients with IDEM spinal cord tumors operated in Neurosurgery department at Sohag university Hospital


Eligibility Criteria:
Inclusion Criteria:

* patients with intradural extramedullary lesion in dorsolumber region

Exclusion Criteria:

* previous history of spinal surgery
* unfit medical patients
* multiple level affection
* associated cervical lesion
* unstable segment
Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study

Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents


Eligibility Criteria:
Inclusion Criteria:

* BMI equal or higher than 95th percentile for age and gender
* 13-18 years old

Exclusion Criteria:

* medication with weight gain as side effects
* diagnosed with having eating disorder
* pregnant
* clinical mental health conditions
* psychosis
Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer

This study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in treatment of non-small cell lung cancer bone metastasis'pain relief or not.

Further study details as provided by oncology center of Daping hospital

Eligibility Criteria:
Inclusion Criteria:

* Pathology or cytology was diagnosed with non-small cell lung cancer, and bone metastases was confirmed by CT or MRI , and the patients have to need intervention treatment.
* VAS score\>2 points.
* No paraplegia,
* No pathological fractures of bone related events which require surgical intervention,
* No major organ dysfunction,laboratory indexes meet the following requirements: Haemamoeba \>4.0 x 10\^9/L, Neutrophile granulocyte \> 2 x 10\^9/L, the platelet count\>100 x 10\^9/L, hemoglobin\>100 g/L; Liver result: the serum bilirubin is lower than normal ceiling; ALT and AST is lower than the maximum normal 1.5 times; Cr\<265 umol/l or 3.0 mg/dl, creatinine clearance\>60 ml/min.

Exclusion Criteria:

* The patients who have allergy of Bisphosphonates and zoledronate.
* The patients who receive Molecular targeted therapy and chemotherapy within one month，The patients who receive Calcitonin and Aminoglycoside therapy in one week.
* The patients who receive Pamidronic Acid in 28 days，The patients original sites receive radiotherapy before.
* The patients who have history of thyroid surgery，receive tooth extraction in 2 weeks，and have been suffered from Bone Fracture and paraplegia.
* The patients who have Serious internal medicine diseases and acute infection.
* The patients With a history of psychiatric
* Pregnancy or breast-feeding women, men have fertility requirements
* Patients within clinical trials or not more than 30 days
Genetic Testing in Primary Congenital Glaucoma Patients

Primary congenital glaucoma patients and their immediate relatives will undergo complete ophthalmic examination and an interview with a geneticist. A blood sample will be drown from all participants for DNA analysis.

The CYP1B1 gene coding sequences will be screened for all individuals. If no mutation or only one heterozygous mutation will be found in the CYP1B1 gene, screening for MYOC gene mutations will be performed.

Primary congenital glaucoma (PCG) is usually present in the neonatal or

infantile period and is accompanied by corneal opacity and edema, buphthalmos, increased intraocular pressure, optic nerve cupping, and at times, ensuing severe visual impairment. The incidence of the disease varies significantly in different geographic regions and is more frequently found in certain ethnic groups, especially where consanguinity is prevalent. The incidence in Western countries has been reported to range from 1:5000 and 1:10000 births, and in populations where consanguinity is prevalent, such as among Slovakian Gypsies and Saudi Arabians, the incidence ranges from 1:1250 and 1:2500 births, respectively. PCG is believed to be an autosomal-recessive transmitted disease with incomplete penetrance. Three different loci have been mapped for it, i.e., GLC3A on chromosome 2p21, GLC3B on 1p36.2 and GLC3C on 14q24.3. The major gene that currently has been identified to be associated with PCG is the CYP1B1 gene at locus GLC3A, which encodes a member of the cytochrome P450. The frequency of mutations in the CYP1B1 gene in PCG patients varies in different geographic locations and ethnic groups. For example, mutations in the CYP1B1 gene are found in 33% of patients in Japan and Indonesia, while among Saudi Arabian and Slovakian Gypsy patients, the incidence rises to 94% and 100%, respectively. Mutations in myocilin (MYOC) have also been associated with PCG.

Determining the presence of CYP1B1 mutations in PCG patients will improve our ability to counsel parents regarding cause, inheritance and the risk of it in future offspring.

The aim of the present study is to characterize the phenotype and determine the role of CYP1B1 and MYOC mutations in PCG in Israeli populations

Eligibility Criteria:
Inclusion Criteria:

* Primary congenital glaucoma pediatric patients
* Glaucoma that was diagnosed within the first 12 months of their life
* Primary congenital glaucoma pediatric patients's parents

Exclusion Criteria:

* any other ocular or systemic diseases
Evaluation of University Students' Knowledge Levels and Perceptions of the Physiotherapist

The aim of this study is to determine the knowledge, perceptions and perspectives of students about physiotherapy and rehabilitation profession, who are studying in different departments, especially in the health sector in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-25 who are students and continue their education at Acibadem Mehmet Ali Aydinlar University

Exclusion Criteria:

* Students in the physiotherapy and rehabilitation department
* Students with serious mental illness
Evaluation of the Implementation of the Hemispheric Dominance During Development

Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning?

The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks.
* normal group of children : A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).
* Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion Criteria:

* severe congenital malformation
* Any refusal of a parent .
* Children with severe impairment of the general condition and vital functions
* Children with dermatitis of the face or scalp
* Children treated with ventilation High Frequency (HFO )
* Presence of intravenous access on the scalp ( preventing the realization of the ETF , EEG or NIRS .
Bioequivalence Study Comparing Two Formulations of Escitalopram

This is a bioequivalence study, which is a regulatory requirement to ensure comparable in vivo performance, i.e. similarities in terms of safety and efficacy, after administration of two different dosage forms of escitalopram.

All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test treatments B and C will each be compared to Treatment A, which is the active comparator (reference formulation).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 19 kg/m2 and 29 kg/m2, inclusive
* The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests

Exclusion Criteria:

* The subject has taken disallowed medication within 1 week prior to the first dose of investigational medicinal product (IMP), or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer
* The subject has a significant history of drug or alcohol abuse
* The subject has taken any investigational products within 3 months prior to the first dose of IMP
* The subject has a history of or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder
* The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of IMP
* The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to the first dose of IMP
* The subject has any concurrent illness that may affect the particular target or metabolism of the IMP
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Other inclusion and exclusion criteria may apply.
Perceptions and Barriers About Cessation of Smoking Among IBD Patients

This study will investigate the perception of the relationship between smoking and inflammatory bowel disease by surveying inflammatory bowel disease patients. Afterward, the relationship between smoking and inflammatory bowel disease will be explained, and the smoking cessation rate will be investigated three months later.

A survey is conducted on patients with inflammatory bowel disease (IBD). Current smoking status, daily smoking amount, smoking period, perception of smoking effect on the induction of Crohn's disease (CD) or ulcerative colitis (UC), and perception of the effect of smoking on the course of CD or UC were investigated. Moreover, the intention to quit smoking is investigated. After the survey, information on the effects of smoking on CD or IBD is provided, and smoking cessation education is provided. After three months, the patients' smoking behavior was investigated, and the smoking cessation rate was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with inflammatory bowel disease or newly diagnosed with inflammatory bowel disease

Exclusion Criteria:

* Those who do not agree to the survey or smoking cessation education
Sarecycline Truncal Acne Safety and Efficacy Response

The purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. Patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. Lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 9 or above.
* Clinical diagnosis of moderate to severe truncal acne based on IGA

Exclusion Criteria:

* Known or suspected allergies or sensitivities to any components of the study drug.
* Any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline.
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part in the trial.

Other protocol defined Inclusion/Exclusion criteria may apply.
Operative Treatment of Ankle Fractures

Patients who underwent operative treatment of an ankle fracture with or without following removal of the osteosynthetic material are examined by a specific ankle provocation test, a questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome compared to a healthy control group

The study includes all patients operated from 09.12.2012 to 31.12.2020. Patients will undergo an X-Ray at least two years after primary surgery or at least one year after removal of the osteosynthetic material. The patients operated from 09.12.2012 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.

All patients in the retrospective cohort are contacted at least 2 years after surgery (or 1 year after removal) via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo X-Ray of the affected and the non-affected ankle.

All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic. In case of informed consent, they are invited to the study site at least 2 years after surgery. They are asked to complete the questionnaires and they undergo na X-Ray of the affected and non-affected ankle.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 and younger than 51 years
* Operative treatment of an ankle fracture
* Time operation to follow up: at least 2 years
* Time removal of osteosynthetic material to follow up: at least 1 year
* Time operative treatment to removal of the osteosynthetic material: at least 9 months
* Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion Criteria:

* Other pathologies of the lower limb of the affected and/or non-affected side (fractures, pre-existing arthrosis or operative treatment of the affected and/or non-affected limb)
* Pre-existing vascular (peripheral arterial disease, diabetes) or neurological diseases of the lower extremities
* Women who are pregnant
* Prevalence of an infection of the implanted osteosynthetic material
AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS

AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndromes undergoing invasive coronary angiography as clinically indicated.
* Availability of a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access).
* Age ≥18 years.

Exclusion Criteria:

* Individuals presenting for a non-emergent (elective) cardiac catheterization.
* Individuals presenting with chronic coronary syndrome (CCS) or stable angina symptoms.
* Individuals without symptoms suspicious for acute coronary syndromes.
* Individuals with contraindications for cardiac catheterization.
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy

The purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16. The study consists of two parts. Part 1 will include the first 16 weeks of the Treatment Period and Part 2 will include the last 24 weeks of the Treatment Period.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written and dated informed consent given before any study related activity is performed
* Participants with at least 6 months history of chronic plaque psoriasis
* Participants diagnosed with moderate-to-severe plaque psoriasis at the Screening Visit
* Candidate for systemic treatment for plaque psoriasis at the Screening Visit

Exclusion Criteria:

* Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
* Other forms of psoriasis than chronic plaque-type
* Participants with drug-induced psoriasis at the Screening Visit
* Participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis
* Participants with history of hypersensitivity or allergy to the study drugs
* Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
* Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the Screening visit
* Active infectious disease at the Screening Visit
* Participants positive test for human immunodeficiency virus or any other immunosuppressive disease
* Previous exposure to fumarate-based drug or a biologic systemic treatment
* Live vaccination within 4 weeks prior to the Baseline Visit
* Participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
* Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
Subjective Outcomes After ACL Reconstruction With BQT Autograft

The purpose of the study is to compare short-term patient reported outcome measures (PROM) of Bone-Quadriceps-Tendon (BQT) autograft with Semitendinosus-Gracilis (STG) and Bone-Patellar-Tendon-Bone (BPTB) autografts following Anterior Cruciate Ligament Reconstruction (ACLR).

The PROM used are Knee Injury and Osteoarthrithis Outcome Score (KOOS) and Tegner. Difference in change in KOOS, KOOS subscales and Tegner from preoperative baseline to one-year follow-up and absolute KOOS, KOOS subscales and Tegner at one-year follow-up were evaluated. All of which were BQT compared to STG and BPTB, respectively. The primary outcome is change in KOOS from preoperative baselinge to one-year follow-up. Other outcomes are secondary.

The hypothesis was that patients receiving the BQT autograft show similar results in KOOS, KOOS subscales and Tegner as patients receiving STG or BPTB autografts.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Revision ACL Surgery
* Multiligament surgery
* Nonresponders in PROM at preoperative baseline or one-year follow-up
Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients

Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.

Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* (1) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies.

Exclusion Criteria:

* (1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding