cyrilzakka/clinical-trials huggingface dataset:
Courageous Parents, Courageous Children

Anxiety disorders usually start in childhood and adolescence and are associated with social and occupational difficulties in adulthood. Children who have a parent with an anxiety disorder and who find new situations distressing and avoid them are at an increased risk for developing an anxiety disorder. Research suggests that anti-anxiety parenting can help children grow up courageous and calm. It is, however, difficult to parent in an anti-anxiety way when the parent has an anxiety disorder himself or herself.

This research study will test the efficacy of a new program designed to prevent the onset or persistence of anxiety disorders in children at risk for anxiety disorders. The investigators will first help parents learn skills to cope with their own anxiety and then coach them to share these skills with their children and parent in an anti-anxiety way. The goal is to intervene early enough in the children's lives so that they can be free of anxiety disorders and lead happy, healthy and productive lives in adulthood.


Eligibility Criteria:
Parents:

Inclusion criteria:

Parents will be included if they have a current diagnosis of at least one anxiety disorder, one or more children between the ages two and eight years in their own care, capacity to provide informed consent, and ability to speak English well enough to benefit from the intervention.

Exclusion criteria:

Exclusion criteria for parents are receipt of an adequate course (6 or more sessions) of structured psychological therapy in the past 12 months, or plans to move out of Nova Scotia within the next three years. We will include parents with co-morbid mood disorders. However, those whose mood disorder is the primary complaint will be referred for treatment for their mood before being re-assessed. We will exclude parents with disorders that would interfere with the standard treatment protocol delivery; these include lifetime schizophrenia, autism, intellectual disability and current drug and alcohol use disorder.

Offspring:

Inclusion criteria:

Children are eligible if they are aged two to eight and if they have a score of inhibited temperament (negative emotionality) one standard deviation or more above the mean of an age-matched normative sample on the Laboratory Assessment of Temperament.

Exclusion criteria:

Those with lifetime schizophrenia, autism, general intellectual disability, and current drug and alcohol addiction will be excluded, as these conditions would impact on the standard delivery of the parenting intervention. We will exclude children currently receiving treatment for anxiety.
Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients

Explore the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model.

The goal of this clinical trial is to text about in the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model. The main question it aims to answer are:

* Changes in sedentary behaviour in elderly stroke patients Participants will received a 12-week sedentary behaviour intervention programme.

Researchers will compare differences in sedentary behaviour between routine care control and intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for cerebral infarction and cerebral hemorrhage in the Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019 issued by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association;
* Age ≥60 years;
* National Institute of Health stroke scale (NIHSS) score \<5 (i.e., mild stroke), stable vital signs, and able to cooperate with the survey;
* Total sedentary time ≥6 hours/day measured using the International Physical Activity Questionnaire;
* Resident for ≥6 months in the community residents;
* Patients or under the guidance of others can use WeChat.

Exclusion Criteria:

* Functional ambulation category scale (FAC) score \<2;
* serious myocardial infarction, cerebral hemorrhage and pulmonary embolism in the acute stage of the need to limit the activities of the situation;
* is participating in other physical activity or sedentary behavioral intervention programs;
* severe muscle weakness, fractures and other diseases resulting in limited physical activity;
* serious mental disorders such as schizophrenia or dementia resulting in severe cognitive impairment;
* speech and communication disorders.
Prevalence of Neglected Side Effects to Radical Prostatectomy

The purpose of this exploratory data collection is to strengthen our knowledge of some of the rarer distresses following surgical removal of the prostate. In general these are:

* Side effects related to sexuality, including:
* Altered perception of orgasm,
* Orgasm associated pain,
* Penile shortening and deformity.
* Side effects related to urinary incontinence.
* Urinary tract infection after operation.
* Influence of distress on sexual quality of life.
* Influence of distress on the patient´s sex drive.

In addition information on a range of demographics and information on the patient´s erectile function will be collected.

Approximately 1 out of 6 men will, at some point of their life become diagnosed with prostate cancer. Treatment options included medication therapy, radiation therapy, and surgery. This data collection aims to gather information on some of the lesser known distresses experienced by patients following surgical removal of the prostate gland.

Erectile dysfunction and urinary incontinence remain common, but thoroughly investigated side effects. Thus they will not be of primary interest here, but considered factors for correlation. During the last couple of years, a series of lesser known side effects have come to investigators attention. These include altered perception of orgasm, orgasm related pain, sexual-related urinary incontinence, and shortening -and impairing deviations of the penis. Few studies have investigated these side effects, and clear knowledge of why, and how often these problems arise, remain scarce. This study will contribute to that knowledge.

In addition, the questionnaire will include a series of exploratory questions, concerning lower urinary tract infections, treatment satisfaction, alcohol and urinary incontinence, reasons for abandoning treatment for erectile dysfunction, and an assessment of libido prior to and after radical prostatectomy.

The data collection will include approximately 400 patients from the department of urology at the University Hospital in Herlev, Copenhagen, Denmark. A questionnaire will be sent to patients together with a stamped addressed envelope in order to optimize the response rate. Results will be kept in a separate database from personal information.

Eligibility Criteria:
Inclusion Criteria:

* All patient who have undergone radical prostatectomy at the department of urology, Copenhagen University Hospital, Herlev, between 3 months and 3 years before initiation of the study.

Exclusion Criteria:

* Incontinence associated with sexual activity Prior to surgery
* Peyronies disease Prior to surgery
* Orgasm related pain Prior to surgery
* Anorgasmia Prior to surgery
Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab

The objective of this non-interventional, observational study is to assess the effect of adalimumab on health-related quality of life in participants with Psoriasis in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of Psoriasis by investigator.
* Participant (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
* Participant must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

* Participants who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
* Participation in any Psoriasis-related clinical trial at the time of enrolment, at baseline or at any point during the study period.
* Participants, who in the investigator's view, may not be able to accurately report their questionnaires
Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes stress- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic stable angina pectoris.
* Documented myocardial segments with reversible ischemia
* AP CCS class of III-IV.
* Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Exercise tolerance time \< 10 min (modified Bruce)
* Two ETT tests results (within two weeks) averaging no more than 25% of their mean
* Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Signed an IRB approved informed consent form.
* Life expectancy of \>12 months.

Exclusion Criteria:

* Intraventricular thrombus
* Malignancy in the area of treatment
* Severe COPD
* No smoking during the study procedure
* MI less \<3 months prior to treatment
* Severe Valvular disease
* Child bearing potential
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Had a negative sentinel lymph node biopsy
* Participant has not been previously treated for melanoma
* ECOG 0 or 1
* Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma

Exclusion Criteria:

* History of ocular or mucosal melanoma.
* Pregnant or nursing women
* Participants with active known or suspected autoimmune disease
* Known history of allergy or hypersensitivity to study drug components
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply.
Evaluate the Working Environments of Individuals Working From Home During Covid-19 Outbreak

The study aims to evaluate the working environments of individuals working from home during the covid-19 outbreak and the effect of the working environments on their musculoskeletal system.

The study will include people between the ages of 18-65 who work from home (works in the office before isolation) as a part of the Covid-19 isolation measure. The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). Musculoskeletal symptoms will be analyzed by using the Standardised Nordic Questionnaires (NMQ). Pain will be analyzed by using the Visual Analogue Scale (VAS) .

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65
* works from home
* works in the office before isolation

Exclusion Criteria:

* have any systemic disease that may affect on musculoskeletal system such as fibromyalgia, myofacial pain syndrome, etc.
* have any vision problem
* have difficulty of understanding and following online survey
* have any physical disability
* have self-reported computer use for less than four hours on a typical workday
Effects of Pericapsular Nerve Group Block Applied in Patients Undergoing Hip Fracture Surgery.

In this study, it was aimed to compare the multimodal analgesia application or the pericapsular nerve group (PENG) block methods in patients undergoing hip surgery. The effectiveness and benefit rate of the PENG block in postoperative pain will be evaluated.

Postoperative pain, need for additional analgesia, range of motion of the hip joint, mobilization time, length of hospital time and adverse events in patients undergoing hip fracture surgery with and without PENG block will be investigated.

This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were randomly divided into two groups using the sealed envelope method, Group I: those who received PENG block (n:35) and Group II:Those who did not receive PENG block (control group) (n: 35).

All patients will undergo hip fracture surgery by the same surgical team. Each patient will be informed about the procedure to be performed during anesthesia and surgery, and signed informed consent will be obtained before the procedure.Patients in Group I who will undergo the PENG block method; Before surgery, after spinal anesthesia, PENG block is performed under sterile conditions under ultrasonography guidance. With the patient supine, a 2-5 MHz, low-frequency, curvilinear probe is placed in the transverse plane medial to the anterior inferior iliac spine (AIIS), with the medial end of the probe rotated approximately 45° counterclockwise to align with the superior pubic ramus.

With the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and the pubic ramus and 20 ml of 0.5% bupivacaine is administered.

As for the patients in Group II (control group); It is a routine practice at the end of surgery; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team.

For routine postoperative multimodal analgesia, intravenous PCA (patient controlled analgesia) was administered to patients in both groups with tramadol 50 mg at a basal rate of 10 mg / hour after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv. (Given every 8 hours)

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo hip fracture surgery Women and men aged 30-85

Exclusion Criteria:

* Patients under 30 years old, over 85 years old
* American Society of Anesthesiology (ASA) IV,
* Those with cognitive impairment (alzheimer, dementia, delirium, etc.)
* Those with application site infection
* Those who are allergic to local anesthetic substances
* Patients are non-consenting patients.
A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants

The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be aged 18 years of age or greater, at the time of signing the informed consent
* Participant must be a premenopausal female with no indication of abnormal or gestational/lactational hypothalamic-pituitary-ovarian function. Menopause will be defined for the purpose of this study as amenorrhea of ≥12 months for which no other reason has been identified
* Participant must not be pregnant or breastfeeding. Participant must agree to use an effective form of contraception (other than hormonal methods) for the duration of the Treatment Period and for at least 90 days (or 5 terminal half-lives) after the last dose of study medication
* Participant must be in good physical and mental health as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Participant must have body weight of at least 45 kg and body mass index within the range 18 to 30 kg/m\^2 (inclusive)

Exclusion Criteria:

* Participant has a history of discontinued use of oral contraceptives (OC) for medical reasons
* Participant has any medical reason that would contraindicate the administration of OC (per label)
* Participant has used any of the following within the specified time period prior to first dose of study medication:

  1. Oral contraceptive or oral hormone replacement therapy within prior 30 days
  2. Implanted hormonal contraceptives within prior 6 months
  3. Injectable contraceptives within prior 12 months
  4. Topical controlled-delivery contraceptives within prior 3 months
  5. Hormone-releasing intrauterine devices ('coils') within prior 3 months
* Participant has other relevant gynecological disorders (such as premature ovarian failure or endometriosis)
* Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline (Day -1) that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any study participant with any of the following findings will be excluded:

  1. QT interval corrected for heart rate using Bazett's formula (QTcB) or Fridericia's formula (QTcF) \>450 ms in 2 of 3 ECG recordings;
  2. other conduction abnormalities (defined as PR interval ≥220 ms);
  3. irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats. In case of an out-of-range result, 1 repeat will be allowed. If the result is out-of-range again, the study participant cannot be included
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children

Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery \& early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.

Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time \& hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.

Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.

In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.


Eligibility Criteria:
Inclusion Criteria:

1. American society of anesthesiologists (ASA) class I and II
2. Children undergoing unilateral open renal surgeries

Exclusion Criteria:

1. Parents refusal for the block
2. Bleeding disorders (platelets count \< 100,000/uL; INR \> 1.5; PC \< 60%)
3. Skin lesion, wounds or infection at the puncture site.
4. Known allergy to local anesthetic drugs
N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:

In this study, we retrospectively will investigate safety and efficacy of NAC dose given in paracetamol toxicity as an adjuvant therapy in critically ill COVID-19 patients with acute respiratory distress and determine whether NAC in high doses can avoid respiratory failure in patients with COVID-19.

Type of Study:Retrospective Observational Cohort Study. Study Setting: Ain shams university hospitals . Study Period: from December 2020 to February 2022 Study Population:Patients aged 18 years or older of both genders diagnosed with confirmed critically ill COVID-19 .

This is a retrospective observational study in which all cases will be collected from ICU of Ain shams university hospitals during COVID-19 outbreak. All data will be extracted from clinical records. All patients initially admitted to ICU with SPO2 less than 94 % will be included between December 2020 to February 2022. Infection with COVID-19 was confirmed by PCR. All patients received standard care, according to the institutional protocol.

Laboratory and Radiological Investigations Demographic, clinical, laboratory, management, and outcome data will be obtained from the medical records. Routine laboratory tests were done for all patients, including CBC, C-reactive protein, renal profile, coagulation profile, liver profile, lactate, electrolytes, procalcitonin, ferritin and D-dimer.Infection with COVID-19 was confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab. Chest computed tomography (CT) was also done for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Oxyhemoglobin saturation (SaO2) of less than 94% while breathing ambient air

Exclusion Criteria:

* Need for immediate mechanical ventilation on admission, known allergy or hypersensitivity to NAC, end stage renal and liver diseases, heart failure and pregnancy.
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Patients with XLH

Exclusion Criteria:

1. Have an active infection or chronic inflammatory disease
2. Have uncontrolled hypertension
3. Have uncontrolled diabetes mellitus
4. History of known immunodeficiency
5. Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
6. Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening
7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.


Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Diagnosis of Cystic Fibrosis
* Presenting with Infective exacerbation

Exclusion Criteria:

* Unable to give consent
* Allergy to study medications
* Intolerance of aminoglycoside antibiotics
* Pseudomonas resistant to study antibiotics
* On the active transplant list or FEV1\<20% predicted
* Pregnancy/breast-feeding
* Co-existent ABPA requiring a change in treatment
* Co-existent mycobacterial infection
* A previous participant in the study