cyrilzakka/clinical-trials huggingface dataset:
Validation of Hausa Oswestry Disability Index, Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire,Global Rating of Change Scale and Back Beliefs Questionnaire in Low Back Pain Patients

Oswestry Disability Index (ODI), Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire (RMDQ), SF-12 Health Survey, Pain Catastrophizing Scale (PCS), Fear-Avoidance Beliefs Questionnaire (FABQ), Global Rating of Change Scale and Back Beliefs Questionnaire (BBQ) are important and widely used validated patient self-reported measures commonly used in clinical trials and health research involving patients with low back pain (LBP). However, to date, validated Hausa versions of these tools are unavailable for use despite not only Hausa language is commonly spoken in Nigeria but in other parts of the world.

The purpose of this study is to perform, using evidence-based guidelines, translation, cultural adaptation and validation of the ODI, NPRS, RMDQ, SF-12 health survey, FABQ, PCS, GROC and BBQ into Hausa language among patients with LBP in Northern Nigeria.

This study will test the psychometric properties (i.e validity; reliability, and ceiling effect) of the ODI-H, NPRS, RMDQ-H, SF-12-H, FABQ-H, PCS-H, GROC and BBQ-H in Hausa-speaking patients with LBP. Rural and urban participants with LBP will be recruited purposively. Copies of the translated Hausa versions of the NPRS, ODI, RMDQ, SF-12, FABQ, PCS, BBQ as well as VAS for pain and disability will be self or interviewer-administered. Lumbopelvic mobility using finger-floor distance test (FFD) will be also measured. The Hausa versions of the ODI, NPRS, RMDQ, SF-12, FABQ, PCS, GROC and BBQ will be administered again a week after.

Data will be analysed using descriptive, correlation, and factorial analysis on IBM SPSS (version 23.0) at alpha level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 18 and 70 years old.
* Nonspecific low back pain lasting for more than 12 weeks.
* Resident in the selected rural and urban communities in Kano State Nigeria.
* Ability to read/understand English or Hausa language.

Exclusion Criteria:

* Previous history of back surgery.
* Spine pathology (e.g. tumor, infection, fracture)
* Severe cognitive impairment
* Impaired capacity to be interviewed
* Current pregnancy
Genetic Risk: Whether, When, and How to Tell Adolescents

This study is being conducted to learn more about family communication of genetic risk information. Semi-structured interviews lasting up to one hour will be conducted with three populations: parent/child pairs at risk for Huntington's Disease, parent/child pairs at risk for hereditary cancer, and genetic counselors.

The investigators currently lack an adequate understanding of how parents and children feel about genetic risk/status, how it is communicated, and how it influences wellbeing and family relationships. This understanding is vital in order for genetic counselors and other health care professionals to provide the best guidance possible to families. However, little research has been conducted on the impact of genetic risk information or testing on children from the perspective of the child. The research proposed here is uniquely positioned to help fill this gap.

For this study, the investigators will interview 15-20 parent/child pairs who are at risk for Huntington's Disease (HD), 15-20 parent/child pairs who are at risk for hereditary cancer, and 15-20 certified genetic counselors. Interviews will last no more than one hour and will be conducted at a time and place that is convenient for the participant. The investigators will offer participants a choice of conducting the interview in a private conference room at the Berman Institute of Bioethics, or remotely by Skype or telephone. Parents and children will be interviewed separately. Parents will be asked about the decision process behind how and when they disclosed genetic information to their child, style of family communication, advice for other parents in similar situations, and other questions related to the subject of communication of genetic information to minors. Children will be asked about their experience learning genetic risk information, style of family communication, how they felt, advice for other kids in similar situations, and other questions related to the subject of communication of genetic information to minors.

Eligibility Criteria:
Inclusion Criteria:

* Parents at-risk for HD, affected by HD, or be the spouse/partner of someone living who at risk for or affected by HD.
* Parents who have or have had a diagnosis of hereditary cancer, or the spouse/partner of someone living who has or has had had a diagnosis of hereditary cancer.
* Children ages 15-17 who are at risk for either HD or hereditary cancer

Exclusion Criteria:

* Parents and children who have not yet communicated about genetic risk
* Children younger than age 15
Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology

The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.

HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.

Eligibility Criteria:
Inclusion Criteria:

* Subject over 50 years old
* BPH whose symptoms require surgical management
* Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
* IPSS score \> 15 and Quality of Life score ≥ 3
* Maximum urinary output (Qmax) \< 15 ml/sec

Exclusion Criteria:

* Inability to read or write French
* Patients with comorbidities contraindicating general anesthesia
* Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
* History of BPH surgery
* History of prostate cancer
* Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) \< 40g
* Existence or history of urethral stricture
* Existence or suspicion of a "neurological" bladder
* Positive preoperative cytobacteriological examination not treated appropriately
* Adult patients subject to a legal protection measure or unable to express their consent
* Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings

Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Clinical trials conducted in practice settings can demonstrate the degree to which evidence-based treatments are appropriate for larger scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in the elementary school clinic setting. A randomized, controlled trial design has been employed, comparing immediate treatment and a three-month waitlist. The trial is being conducted in several Los Angeles area elementary schools and is only available to children in these particular schools. To ensure that the CBT intervention is flexible and capable of matching the characteristics of various school settings, clinicians, and referred children, a modular treatment approach is employed. The study design includes elements to ensure high quality data, such as the use of independent evaluators and tests of treatment fidelity. Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a semi-structured diagnostic interview. Therapy and clinical supervision is provided by the research team. It is hypothesized that children receiving immediate treatment will have significantly lower anxiety scores than children assigned to the waitlist at the posttreatment/postwaitlist assessment. If results are favorable, further exploration of dissemination of CBT into school clinic settings may be indicated.


Eligibility Criteria:
Inclusion Criteria:

* The child meets DSM-IV criteria for separation anxiety disorder (SAD), social phobia, or generalized anxiety disorder (GAD) based on a diagnostic interview
* The child is not taking any psychiatric medication at the initial assessment, or is taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment)
* If medication is being used, children will maintain that dose throughout the study

Exclusion Criteria:

* The child is currently in psychotherapy
* The family is currently in family therapy or a parenting class
* The child begins taking psychiatric medication or increases his/her dose of medication during the intervention
* For any reason the child or parents appear unable to participate in the intervention program.
MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).


Eligibility Criteria:
Inclusion Criteria:

* Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment
* Subjects need to have

  * one lesion that can be irradiated
  * at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
  * one lesion that can be biopsied before treatment with SBRT and MSB0010445
  * one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445
* The lesion that is biopsied at Baseline can be the lesion that will be irradiated
* The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline
* Signed written informed consent
* Male and female subjects at least 18 years of age
* Life expectancy greater than or equal to (\>=) 4 months
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Active central nervous system metastasis
* Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
* Pre-existing pericardial effusion or history of Grade \>=2 pleural effusion or ascites within 3 months before first dose of SBRT
* Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
* Other protocol defined exclusion criteria could apply
Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.

Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.

Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult.

This research group has developed an acoustic coupling fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* A diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).
* In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis.
* Karnofsky performance status \>=70

Exclusion Criteria:

* Not able to consent (e.g. severe cognitive impairment)
* Intended biopsy only (meaning: cases not suitable for resection)
* Hypersensitivity to egg protein
* Hypersensitivity to soya or peanut protein
* Hypersensitivity to glycerol
* Pregnancy of breast-feeding
* Intention to become pregnant during the time of the study
Renal Metabolism in Salt-sensitive Human Blood Pressure

Salt sensitive hypertension is a significant health problem worldwide and a primary modifiable risk factor for renal, cardiovascular, and cerebrovascular diseases. Yet, the underlying mechanisms remain poorly understood.

The proposed study determines how renal oxygenation and substrate metabolism differs between individuals with and without salt sensitivity, with the ultimate goal of identifying mechanisms, diagnostic criteria, and treatment strategies for salt sensitive hypertension.

Seventy subjects will be enrolled and randomized to start either a low sodium diet (1200 mg/day) or high sodium diet (\>4200 mg/day) for two weeks. After completion of two weeks, subjects will be switched to the 'other' diet for two weeks after a one-week wash-out. During the screening visit, subject's daily sodium intake will be assessed using multiple methods and further dietary information will be collected to prepare customized low sodium meals. During low sodium diet period, subjects will be supplied with food and will be asked to keep food logs. At the end of two-week period, the study activities described below will be carried out including BOLD MRI imaging along with imaging techniques to assess renal oxygenation levels and perfusion. During high sodium diet period, subjects will be either supplemented with sodium chloride tablets or high sodium foods to achieve a daily sodium intake above 4200 mg/day. If subjects already consume over 4200 mg/day of sodium, no changes will be made to their diet and assessment of oxygenation (BOLD MRI) and perfusion will take place after two weeks.

At the end of high sodium diet, 18 subjects will have renal vein sampling performed (this will be equally divided between salt-sensitive and salt-insensitive subjects and per subject preference as all may not want to have renal vein sampling). Subjects will be classified into salt sensitive or insensitive at the end of low sodium diet period based on BP response for further data analyses.

Eligibility Criteria:
Inclusion Criteria:

* English speaking subjects
* With a spectrum of BPs, ranging from those with Elevated BP through Stage 1 HTN, as defined by the 2017 ACC/AHA HTN guidelines

Exclusion Criteria:

* Non-English speakers
* BP ≤120/80 \& ≥ 140/90 mmHg
* H/o diabetes, congestive heart failure, cirrhosis of the liver, hypokalemia \& other
* electrolyte disturbances
* H/o kidney disease
* Use of glucocorticoids
* Pregnant or nursing mothers
* Presence of bleeding disorders
* Use of anti-platelet and anticoagulant agents such as clopidogrel, aspirin, dabigatran, rivaroxaban etc
* Daily sodium intake ≥ 6000 mg/day
* Presence of pacemaker or other metallic implants
* Allergy to iodinated contrast
* Allergy to shellfish
* Claustrophobia
Bovine vs. Human Milk-Based Fortifier Study

Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. Infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* \<1250g birth weight
* Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient

Exclusion Criteria:

* Infant receives formula or a nutrient fortifier prior to randomization
* \>day 14 at the time of enrollment and enteral feeds have not commenced
* Infants with major congenital or chromosomal anomalies that could impact growth
* Enrollment in another research study affecting nutritional management during the feeding intervention
* Reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued
Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis

To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5% in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.

Phase III clinical trial, systematic sampling, open-label study that evaluated the efficacy of the combination of mometasone furoate 0.1% and 5% salicylic acid in 71 patients with lesions of mild to moderate psoriasis treated for up to 45 days or less than this, at the discretion of the investigator. The results were statistically analyzed and investigational data and their conclusions are referred to in this report.

Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age 18 or older, with good mental health;
* Psoriasis patients with mild to moderate;
* Patients who agreed to participate and signed the
* Clarified (appendix);
* Patients who agreed to return for follow-up visits.

Exclusion Criteria:

* Patients who were making use of biologics, corticosteroids or nonsteroidal anti-inflammatory and non-steroid, or who made use of these topical medications until 15 days before inclusion or 30 days before inclusion when the administration was orally;
* Patients who were exposed to the sun 15 days before the study began or during the course of the same;
* Patients who were making use of acetaminophen;
* Patients who did not agree to the terms described in the IC informed consent, - Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal;
* Lions and other types of skin damage that was not psoriasis;
* Pregnant and nursing women;
* Patients using oral anticoagulants.
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect

The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are:

1. Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility?
2. What medical problems do participants have when taking transvaginal niche resection?

Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility.

Participants will:

1. Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy.
2. Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection.
3. Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery.
4. Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. It was diagnosed by MRI as a large niche (defined as niche with a depth of \&gt;50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm);
2. Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
3. Fertility requirements;
4. Signed informed consent.

Exclusion Criteria:

1. Age below 18 years or over 49 years;
2. Contraindications for intraspinal or general anaesthesia;
3. A (suspected) malignancy or combined benign lesions requiring hysterectomy;
4. Atypical endometrial cells or cervical dysplasia;
5. Uterine or cervical polyps;
6. Submucosal fibroids;
7. Hydrosalpinx.
A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)

A 12-week Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever followed by an additional Open-label Extension Phase.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 FMF disease but no active flare at the time of screening according to Tel Hashomer criteria or EUROFEVER/Paediatric Rheumatology International Trials Organization (PRINTO) criteria for FMF
* Documented to be heterozygous or homozygous for at least one of the known clearly pathogenic MEFV gene exon 10 mutations
* Males and females must be willing to use birth control as indicated

Exclusion Criteria:

* Breastfeeding or pregnant
* Known immunodeficiency or subject is immunocompromised
* Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB