cyrilzakka/clinical-trials huggingface dataset:
Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children

Parents of neurodiverse children are more likely to experience traumatic events related to the care of their child/children. This increases the probability to experience Posttraumatic Stress Injury (PTSI). However, interventions addressing PTSI symptoms in parents are rare.

In this research project the study investigators will test the feasibility and efficacy of e-NET, a distance-delivered, exposure-based intervention for PTSI adapted to the needs of parents of neurodiverse children. E-NET is an adapted version of the Narrative Exposure Therapy (NET), an evidence-based intervention approach for individuals with PTSI who have experienced repeated or continuous trauma. The intervention will be conducted via videoconferencing with trained paraprofessionals. During the intervention a narrative of both positive and negative (traumatic) experiences in the parents' life will be created. The intervention contains approx. 12 one-on-one sessions with a trained paraprofessional via videoconferencing.

The study design is a waitlist control group design. Approx. 20 participants will receive e-NET directly after the baseline survey and 20 participants will receive e-NET approx. 3 months after the baseline survey. To test the efficacy of the intervention, participants will fill out surveys about PTSI and other mental health symptoms before, directly after, and 2 and 6 months after the intervention. Adverse events and distress will be assessed in every session. As part of the baseline, participants will complete the survey "Surviving and Thriving in Parenting Neurodiverse Children" to determine their eligibility for the intervention. Main eligibility criterion is the presence of PTSI symptoms.


Eligibility Criteria:
Inclusion Criteria: Parent/Caregivers must meet the following criteria to be eligible to move on to Consent

1. Be a parent/caregiver of a neurodiverse child
2. Be at least 18 years of age
3. Be able to understand spoken and written English at a Grade 8 level
4. Fulfill the criteria of full or subclinical PTSI according to DSM-5, measured with the Life Events Checklist for DSM-5, the Parent Trauma Checklist and the PTSD Checklist for DSM-5. For this they have to report at least one traumatic event in the LEC-5 or the Stressful Life Experiences of Parents Checklist. To fulfill all PTSI criteria, the participant additionally needs to respond with "moderately" or higher in at least one item for the criteria B and C and two items for criteria D and E. Subclinical PTSI is fulfilled if the participant meets all but one criterion of B, C, D, or E is not met.
5. Have access to a computer with high speed Internet
6. Live in Canada
7. Commit to the requirements of taking part in the study (12 weekly coaching calls)

Exclusion Criteria:

1. Acute suicidal behavior or other extreme forms of self-destructive behavior
2. Moderate to severe symptoms of dissociation
3. Acute psychotic symptoms
4. Previously participated in exposure intervention for PTSI/PTSD
Enhancing Psychological Self-help With Implementation Intentions

Individuals with visible conditions often report experiencing lowered social confidence and encountering intrusive reactions from others, yet relatively few targeted psychosocial self help interventions are available.

The investigators will conduct a randomised controlled trial to compare the efficacy of an adapted form of an existing self-help intervention with an enhanced version of the same intervention that incorporates if-then planning instructions (or 'implementation intentions') and a control condition that will receive support as usual. Participants who self-identify as having a visible condition affecting the skin or hair, or scarring to the skin that negatively affects their social confidence will be allocated to one of three conditions: augmented self-help, standard self help or control. The interventions will be delivered online and participants will complete psychometric outcome measures at two time points, four weeks apart.

It is hypothesised that participants who receive the augmented self help intervention will have a statistically significant decrease in fear of negative evaluation in comparison to both the standard self-help and support as usual control groups.

The proposed research will take the form of a randomised controlled trial conducted in accordance with CONSORT guidelines (http://www.consort-statement.org). Data will be collected online using Qualtrics. Participants will be required to answer all fields on Qualtrics, as a way of managing potential missing data.

Participants will be randomly allocated to one of three groups: (i) psychological self-help augmented with implementation intentions, (ii) standard psychological self-help or (iii) a no intervention waiting list control. Qualtrics will be used to randomly allocate participants to one of the three groups.

A sample size analysis has been conducted and calculated assuming two measures, three groups, an alpha of 0.05, a power of 0.8, and an effect size of 0.25; a total sample size of 120 participants would be needed (i.e. 40 per group). Allowing for an attrition rate of 20%, 144 participants would need to be recruited (i.e. 48 per group). Although participants will be randomised to condition, it is best practice for any differences at baseline to be controlled for in analyses and thus a between factors repeated measure analysis of variance (ANOVA) will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Participants self-identify as having a visible skin difference
* Participants will be aged 18 years or over
* Participants will be fluent in the English language

Exclusion Criteria:

Participants will be excluded if they are currently receiving psychotherapy
Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia

This is a registry study that aims to collect patients' data with advanced-stage rare cancer in Asia-Pacific region. Data includes clinical information, details of treatment, prognosis, pathological diagnosis and genetic biomarkers by next-generation sequencing.

The relationship between cancer types and prognosis, the effect of treatments, and the cancer type-specific incidence of genomic alterations will be investigated to discover more specific and effective treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histological diagnosis of rare cancer, cancer of unknown primary origin, or cancer of rare tissue subtypes of common cancers. (Defined in protocol.)
2. Patients with Advanced stage cancer.

Exclusion Criteria:

1. Patients with complications of cognitive impairment.
Practices of Vitamin D Supplementation Leading to Vitamin D Toxicity

To determine the frequency toxicity (\>150 ng/ml) in subjects for 25-hydroxyvitamin D (25OHD) and evaluate the vitamin D (VD) supplements used by these subjects.

This prospective cross-sectional study was conducted at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH Karachi Pakistan after approval from Aga Khan University Hospital's Ethics Review Committee (ERC ID: 2019-1973-6924). Data of subjects tested for serum 25OHD between April 2020 to March 2021 was reviewed daily and those with 25OHD levels \>150 ng/ml were contacted via telephone. Only the initial results of the subjects tested at Clinical Laboratory were included. Those with incomplete clinical history, 25OHD levels \<150ng/ml, whose contact numbers were unavailable or not answering telephone calls were excluded. To maintain confidentiality all identifiers were removed, and study identity numbers were generated.

After explaining the reason for phone call, verbal informed consent was taken and clinical information of calcium and VD supplementation including prescribed or self-medicated, indications for prescription, formulation strength, total dosage, frequency, duration, and calcium status was collected on a structured clinical history forms. The hypercalcemia was labeled when serum calcium was \>10.2 mg/dl.

Data analysis:

The statistical analysis was performed using the Microsoft Excel 2016. Subjects were categorized into two age groups: \<18 years (pediatric) and ≥18 years (adult). Total doses of VD supplements were added to calculate cumulative supplementation and daily supplementation was calculated by dividing cumulative dose by duration of supplementation.

Descriptive statistics median (interquartile range, IQR) were calculated for numerical data while frequency (percentage) for categorical data. Frequencies of subjects with VD toxicity were derived and their correlates were evaluated in the both the age groups. Demographics (age and gender), calcium status of subjects, indications, formulation strengths, frequency, duration, cumulative and daily dose of supplementation were generated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects WITH serum 25OHD levels \>150 ng/ml.
* Only the initial results.

Exclusion Criteria:

* Serum 25OHD levels \<150ng/ml,
* Incomplete clinical history
* Whose contact numbers were unavailable
* Who were not answering telephone calls
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.

Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.

Hypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.

Design and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.

Study instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.

Interventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.

Main outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.

Data analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.

Expected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.

Eligibility Criteria:
Inclusion Criteria:

* healthy women aged 18 years or above;
* requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;
* having menstrual cycles between 24 and 42 days
* willing to abstain from further acts of unprotected intercourse and;
* available for follow-up over the next 6 weeks.

Exclusion Criteria:

* post-abortion or postpartum and period have not yet returned,
* being on prescription drugs currently
* having unprotected intercourse in this cycle more than 72 hours or more than once before attending the clinic,
* being found pregnant at the time of presentation,
* breastfeeding,
* having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,
* uncertain about the date of the last menstrual period,
* having used hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle,
* having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs,
* having history of ischaemic heart disease in the past one year
* having history of pelvic ulcer disease and/or gastrointestinal bleeding
Ultrasound (US) Measurement of Sarcopenia in the Elder Subject

Sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. Interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. Diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (MRI), computed tomography (CT), biphotonic absorptiometry (DEXA) or bio-impedanceometry. Their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. On the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry.

Previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. Because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia.

The investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. It could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* Age 75 or older
* SARC-F \> 4
* Decrease in muscle strength: grip strength \<27 kg for men and \<16 kg for women; and/or Chair stand test \< 15 seconds
* Patient affiliated or beneficiary of a social security plan
* Patient who has signed informed consent beforehand

Exclusion Criteria:

* Neurocognitive disorder preventing the expression of informed consent
* Lack of a measurement site (muscle resection or amputation)
* Impossibility or contraindication to strict dorsal and/or ventral decubitus
* Any associated neuromuscular pathology that may alter muscle composition and trophicity
* Wearing a pacemaker
* Any state of water inflation or dehydration
* History of surgery on the studied lower limb less than 6 months old
* Patients protected by law under guardianship or under curate, or unable to participate in a clinical study under Article L. 1121-16 of the French Code of Public Health
Pilonidal Sinus-Turkey

In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. .

Primary outcome; To determine the postoperative recurrence rates according to the type of surgical intervention.

The secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.

In this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. The treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. Before collecting any patient data, the Lead Investigator or authorized research team member must be verified as suitable for the study.

Information should be processed on the Case Report Form (CRF) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. Collected participant data will be recorded in the relevant CRFs and patient questionnaires. You should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . As a result; Since all patients who were operated between January 2019 and January 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. Later, the data will be transferred and entered into RedCAP, a remote web-based data collection system.

In CRF, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned.

Eligibility Criteria:
Inclusion Criteria:

- Symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician.

Exclusion Criteria:

* Patients under 18 years of age asymptomatic (Stage I), acute abscess (Stage II), pregnant patients, presence of systemic disease such as DM, UC, Hidradenitis Suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)

This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis \[ND\] and Dialysis \[D\]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis \[PD\] or hemodialysis \[HD\]).

The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks).

Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than \[\<\] 18 years, 6 to \<12 years, 2 to \<6 years, and 3 months to \<2 years). Except for PK and dose change, which is within each age group only.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 3 months to less than (\<)18 years of age.
* Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents \[ESAs\]) or Hgb 9.5 to 12.0 g/dL if using ESAs.
* Written informed consent or assent as appropriate.

Exclusion Criteria:

* Kidney transplant recipient with a functioning allograft.
* Scheduled for elective kidney transplantation within 3 months.
* Transferrin saturation (TSAT) \< 20 percent (%), or Ferritin \<25 nanogram (ng)/milliliter (mL).
* History of bone marrow aplasia or pure red cell aplasia.
* Active hemolysis.
* Other causes of anemia.
* Active gastrointestinal bleeding within the last 4 weeks.
* Active or previous malignancy within the last 2 years.
* Acute or chronic infection requiring antimicrobial therapy.
* History of significant thrombotic or thromboembolic events within the last 8 weeks.
* Heart failure (HF) New York Heart Association (NYHA) Class IV
* Uncontrolled hypertension.
* Alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), bilirubin \>1.5× ULN (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.
Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

This study will assess global small molecule profiles identified in the human gastrointestinal tract of healthy human volunteers.

The gut is home to an extensive interaction between the host and its microbiota, in different regions exposed to endogenous and exogenous signals, such as nutrition, medications, immune alterations, and geographical location-related factors. this study aims to characterize the small molecule profiles of a cohort of healthy individuals, including their polar, semi-polar, non-polar, and protein landscape. The investigators will develop a pipeline enabling to integrate these small molecule profiles with a variety of inter-individual readouts, as assessed in stools of healthy volunteers. Data will be used to characterize molecular patterns potentially associated with a variety of dietary, immune, and health-related human features, with an aim to characterize small molecules for future causative investigation.

Eligibility Criteria:
Inclusion Criteria:

* Normal BMI
* Age 18-70

Exclusion Criteria:

* Known food allergies to the tested food items
* Chronic constipation (less than one bowel movement every two days)
* Chronic treatment with any drug upon enrolment.
* The use of systemic antibiotics, probiotics, or proton pump inhibitors 3 months prior to enrollment.
* Diagnosis of type 1 or type 2 diabetes.
* Any chronic disease at the discretion of the study team- such as active or recent cancer, inflammatory bowel disease, systemic autoimmunity
* Any psychiatric disorders
* Alcohol or substance abuse
* Gut-related surgery, including bariatric surgery, but not including previous appendectomy.
* Pregnancy, breastfeeding, or fertility treatments 6 months prior to enrollment for female participants
A Gene Transfer Study for Late-Onset Pompe Disease (RESOLUTE)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Males and Females ≥18 years of age with late-onset Pompe disease;
* Received ERT for at least the previous 24 months
* Have clinically moderate, late-onset Pompe disease characteristics;
* Agree to use reliable contraception.

Exclusion Criteria:

* Active hepatitis B and/or C;
* Significant underlying liver disease;
* Human immunodeficiency virus (HIV) infection;
* Prior hypersensitivity to rhGAA;
* Pre-existing anti-AAV neutralizing antibody titers;
* High titer antibody responses to rhGAA;
* Requires any invasive ventilation or requires noninvasive ventilation while awake and upright;
* Received any prior vector or gene transfer agent;
* Active malignancy (except non-melanoma skin cancer);
* History of liver cancer;
* Pregnant or nursing women;
* Any evidence of active infection at the time of SPK-3006 infusion.