cyrilzakka/clinical-trials huggingface dataset:
Engaging Siblings of Adults With Autism in Future Planning

The goal of this pilot study was to develop and obtain preliminary feasibility and effectiveness data of a telehealth program (Siblings FORWARD) to help siblings of autistic adults work with their families to plan for the future. The main questions it aimed to answer were:

* Is the Siblings FORWARD program feasible to implement via telehealth in the community setting?
* Do siblings benefit from participation in the Siblings FORWARD program?

The Siblings FORWARD program involves 6-7 individualized telehealth sessions with a trained community facilitator. Researchers compared participation in the Siblings FORWARD program to an information-only control condition.

The researchers developed a program to facilitate the engagement of adult siblings to work with their families to plan for the future of their autistic sibling. Siblings FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) targeted common barriers to sibling involvement in family future planning, including improving family communication around difficult topics, increasing siblings' knowledge of and confidence in accessing autism service systems, and anticipating and proactively problem-solving barriers to future planning. The Siblings FORWARD program was developed in collaboration with community organizations, with input from siblings, autistic adults, and community providers. Siblings FORWARD was implemented in a community setting, with trained program facilitators. A small randomized controlled trial tested participation in Siblings FORWARD compared to information about services only.

Eligibility Criteria:
Inclusion Criteria:

Siblings of adults with autism spectrum disorder (ASD):

* Have one or more adult brother(s) or sister(s) with ASD who are either biologically related and/or were raised in the same family of origin (e.g., adopted, step, or foster siblings)
* Age 18+.
* English or Spanish fluency.

Autistic Adults:

* Have an ASD diagnosis.
* Have an adult sibling
* Age 21+.
* English or Spanish fluency if verbal.

Exclusion Criteria:

Siblings of autistic adults:

-Siblings will be excluded if they have an ASD diagnosis themselves or if they have any disability that would interfere with their ability to engage meaningfully in future planning for the autistic adult.

Autistic adults:

-None
Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain

Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications during pregnancy, particularly in women with gestational weight gain (GWG) that falls over the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to reduce some complications in women with T2DM and GDM. The aim of this project was to assess the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM and GDM.

This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or GDM were invited to participate. The dependent variable was GWG and the main independent variables were MNT and eating behaviors. Data were obtained from medical records or interviews. Multiple linear regression models were used to assess associations.

Eligibility Criteria:
Inclusion Criteria:

* Women who had given birth and with known T2DM.
* Women who had given birth and with GDM diagnosed during pregnancy.

Exclusion Criteria:

* Women with multiple pregnancies.
* Women with type 1 diabetes mellitus.
* Women with glucose intolerance.
* Women with chronic diseases.
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
2. When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
3. ECOG Performance Status of 0 or 1
4. Patient must have adequate tumor sample for biomarker assessment
5. At least one measurable lesion
6. Adequate organ function

Exclusion Criteria:

1. There are untreated or active central nervous system (CNS) tumor metastases
2. There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
3. Major surgery within 4 weeks prior to enrollment
4. Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
5. Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
6. Uncontrolled intercurrent illness
7. Uncontrolled or significant cardiovascular disease
8. Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
9. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
Primary Care-Based Mindfulness Intervention for Veterans With PTSD

Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.


Eligibility Criteria:
Inclusion Criteria:

1) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale

Exclusion Criteria:

1) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.
Diaphragmatic and Pulmonary US for Extubation Success Prediction

The primary objective is to assess whether the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit.

The primary objective is to assess whether the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit. The investigators' null hypothesis is the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound can not predict the success of extubation in adult patients hospitalized in the intensive care unit.

The alternative hypothesis is the fraction of diaphragmatic shortening in combination with the presence / absence of alveolar-interstitial syndrome evaluated through chest ultrasound may predict successful extubation in adult patients hospitalized in the intensive care unit.

The study is a no experimental study of diagnostic test, prospective with longitudinal capture. The study will consist of two parts: the first with the aim of finding the values best combination of sensitivity and specificity compared to extubation success for diaphragmatic shortening fraction and the number of lung quadrants with lines B. In the second part the study will make the prospective validation of these values.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of older
* Hospitalized in medical or surgical intensive care unit
* Successful spontaneous ventilation trial

Exclusion Criteria:

* Patients reintubated after a first failure after extubation
* Injuries to prevent conduct ultrasound
* Pregnancy
* History of neuromuscular disease
* Brain injury that prevented adequate protection of the airway (Glasgow Coma Scale \<8)
* Unilateral or bilateral Pneumothorax
* Presence of chest tube in right hemothorax
* Right subphrenic abscess
* Known uni- or bilateral phrenic nerve injury
* Unilateral or bilateral diaphragmatic Paralysis
* Unwillingness of the patient or guardian to participate in the study
Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®

The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.

The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.

In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.

For this reason, a pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years,
* diagnosis of asthma of 6 months,
* FEV1 ≥ 50% and ≤ 80% predicted,
* reversibility of at least 12%,
* stable asthma for at least 4 weeks,
* inhaled steroids (ICS) at a stable dose within the previous 30 days,
* PIF 30 - 90 lt/min and
* informed consent.

Exclusion Criteria:

* history of other pulmonary disease,
* asthma exacerbation or respiratory infection within the previous 4 weeks,
* hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase, within the previous 30 days,
* heavy smokers,
* change of asthma medication within the previous 4 weeks,
* seasonal asthma alone,
* history of severe heart disease,
* pregnancy or lactation,
* use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study

The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.


Eligibility Criteria:
Inclusion Criteria:

* aged 1 to 13
* Experiment group: Children with cerebral palsy, Control group: Normal children
* Patients who agreed to participate in the study

Exclusion Criteria:

* do not agree with the study
* Those who find it difficult to participate under the judgment of the research director
Differential Study of Muscle Transcriptome

To isolate biomarkers of ALS in muscle

At present, there is no validated biological diagnostic marker for amyotrophic lateral sclerosis (ALS). The main objective of the study is to isolate a set of genes that are specifically dysregulated in muscle from ALS patients.

Gene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)

Eligibility Criteria:
Inclusion criteria :

- Patient with ALS, SMA, or SBMA

Exclusion criteria :

* Indication against biopsy (allergy to anesthetics local haemostasis disorders)
* Treatments that can affect muscle metabolism
Neurobiology of Opioid Dependence: 4 - 4

The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

To evaluate the efficacy and safety of azvudine in treatment of COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years old, gender not limited;
2. Laboratory (RT-PCR) confirmed COVID-19;
3. the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
4. informed consent has been signed.

Exclusion Criteria:

1. known or suspected allergies to the components of azivudine tablets;
2. according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;
3. severe liver disease (TBIL\>=2 times normal upper limit; ALTAST\>=5 times normal upper limit);
4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
5. subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
6. subjectsis currently receiving anti-hiv treatment;
7. women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
8. participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
9. Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies

Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not quantify the prevalence of individuals with habitually deficient or excess iodine intakes. The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and excess. However, little is known about the effects of the inter- and intra-individual variance of UIC.

The aim of the study is to quantify the intra-individual variability in dietary iodine intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the study population and propose sample size recommendations for future iodine nutrition population studies. The results will provide evidence guiding international recommendations for iodine nutrition studies.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant
* Non-lactating
* Non-smoking
* Residence in Switzerland ≥12 months
* Generally healthy
* No family history of goiter
* No exposure to iodine containing contrast agents during the last 12 months - Informed consent given

Exclusion Criteria:

* Participant is not able to understand the study information or procedure, e.g. due to linguistic barriers
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
2. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
3. Native or synthetic (grafts) arteriovenous fistula located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; and
4. Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix Global AV registry).
2. Patient has a non-controllable allergy to contrast; or
3. Patient has another medical condition that, which in the opinion of the Investigator, may confound the data interpretation of is associated with a life expectancy insufficient to allow for completion of patient registry procedure and follow up.
A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.

The Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders. Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire.

As per the previous recommendations, the Spine Functional Index will be interpreted in urdu language and adapted culturally. Participants will be selected by the convenience sampling technique based on pre-defined inclusion and exclusion criteria from a total of 220 participants with spinal Disorders. To test the reliability of Urdu Version Of Spine Functional Index, Neck Disability Index and Roland-Morris Disability Questionnaire in the inter and intra-observer environment, two observers and an interim interval of 45 minutes between the first and second application fill out a questionnaire on the same day for the inter-observer assessment. Observer-1 for the intra-observer evaluation will conduct a third evaluation after 7 days. Using Statistical Package of Social Sciences version 24, data is entered and analyzed. Cronbach Alpha Value is used to analyze center consistency. The intraclass correlation coefficient is used to assess the reliability of the test-retest. For content validity, criteria validity and responsiveness, the Urdu Version Of Spine Functional Index was assessed.

Eligibility Criteria:
Inclusion Criteria:

* The criteria for participation in this study were at least 18 years of age.
* The patient must be diagnosed with musculoskeletal disorder of the spine.
* The patient can be chronic and sub-acute and acute.
* The patient can be referred by a physician or physical therapist.

Exclusion Criteria:

* Lack of reading Urdu or reply to the survey questions were the criteria for exclusion.
* Infectious diseases and patient without spinal disorders were excluded.
* The patients with late surgery or systemic sickness which effects spine was excluded
Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:

- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.

The study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.

Eligibility Criteria:
Inclusion Criteria:

* Patients rehabilitated with immediate function implants for complete edentulous arches through the All-on-4 Concept.
* Patients in need of definitive implant-supported restorations.
* Written informed consent from each patient to participate in the study.

Exclusion Criteria:

- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
The Incidence of Undiagnosed OSA Compared in Multi-ethic Races of Malaysia & the Associated Postoperative Complications

Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow. When this happens, the patient will snore, gasp or choke in the attempt to attain more oxygen. This results in disrupted sleep and the patient may even awake from sleep.

It has been found that a great proportion of Malaysians have habitual snoring and with the increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia.

However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry because these people can come in for surgery. Diagnosis of OSA before surgery is important in order to prepare for the complication related to OSA.

Research staff will interview and examine patients and review their charts to obtain information on patient characteristics. Patients will also be assessed using STOP-BANG Questionnaire \& Epworth Sleepiness Scale.

Anaesthesia and surgery will be performed according to routine standard of care.

Drugs used during anaesthesia, postoperative analgesia and hemodynamic data will be recorded.

During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge. Data on medications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* adult males and females
* age ≥ 18 years
* undergoing elective surgery ( general,regional or local anaesthesia with monitored anaesthesia care)

Exclusion Criteria:

* previous diagnosis of OSA or any sleep-related breathing disorder
* they are unwilling
* their surgery included tonsillectomy, septoplasty, uvloplasty, pharyngoplasty, tracheostomy, or prolonged mechanical ventilation