cyrilzakka/clinical-trials huggingface dataset:
Support Staff-client Interactions With Augmentative and Alternative Communication

This exploratory and observational study focuses on adults with an intellectual disability (ID) and their support workers. Two groups of clients are observed: clients using Key Word Signing, and clients using aided Augmentative and Alternative Communication (AAC). Approximately half of adults with ID is estimated to experience communication difficulties. AAC supports them in their daily communication aiming at optimal participation in society. Current communication models, such as Participation Model (Beukelman \& Mirenda, 2005) and International Classification of Functioning, Disability and Health (WHO, 2001), regard both client-related and environmental factors as important elements of communication. A substantial part of the environmental factors is made up of the communication partners' characteristics. In daycare and residential services for adults with ID the support worker is an important communication partner .

This study aims to:

1. with regard to teaching Key Word Signing (KWS), a specific form of AAC, to support workers:

   Analyse the relation between training method, support workers' attitude, and short and long term sign knowledge.
2. with regard to the use of manual signs in everyday communication between support workers and adults with ID:

   * Identity the support workers' characteristics that may influence the quality/quantity of the communication between adults with ID who use manual signs and their support worker.
   * Analyse the nature of this influence as well as any possible interaction effects with the clients' characteristics.
3. Assess whether an existing instrument, designed for measuring interactions between parents and children with cerebral palsy using AAC, may be used with adults client and support workers.

Eligibility Criteria:
Inclusion Criteria:

* uses AAC with client
* client has congenital intellectual disability
* supports client for at least 6 months

Exclusion Criteria:

* client has dementia symptoms
* client has severe, non-corrected visual impairment
* client has diagnosed autism
Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients

The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.

Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Most patients do not tolerate nasal continuous positive airway pressure device, which is the gold standard treatment of OSA. Press needle is one kind of acupuncture which possesses more safety and convenient, few complications and prolonged period of treatment time compared to conventional acupuncture. To date, there is no study to evaluate the effects of press needle in treating OSA. The investigators hypothesize that press needle is effective with high acceptability among OSA patients.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign inform consent with aged more than 20 years old
* Mild to moderate OSA, AHI \< 30

Exclusion Criteria:

* Severe OSA, AHI \> 30
* Significant lung disease
* Skeletal facial framework problems
* Central apnea
* Undergone oropharyngeal operations, continuous positive airway pressure or oral devices
* Taking hypnotic drugs
* Pregnancy or breast-feeding
* Receiving acupuncture in recent 2 weeks
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
* Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.
* Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

* Have Type 1 Diabetes (T1D)
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliter per minute (mL/min)/1.73 square meter (m2)
* Have acute or chronic hepatitis
* Have had chronic or acute pancreatitis any time.
* Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Ability and willingness to comply with all patient visits and study-related procedures
* Ability to understand and complete study questionnaires
* Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)
* Individuals greater than 14 years of age

Exclusion Criteria:

* Inability to provide informed consent
* Inability to comply with all patient visits and study-related procedures
* Inability to understand or complete study questionnaires
* Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
* Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity
Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.

To determine the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)

To identify the accurate level of upper thoracic spine is essential maneuver during breast surgery and axillary node dissection. Palpation C7 spinous process is most common technique using to identify the level. However, the accuracy was lower than 50%. Ultrasonography has been investigated to identify the cervical nerve roots by differentiating the transvers process of C6 and C7. However, there was no study on the accuracy of using ultrasound to identify cervical spine level before.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer, age \>/= 18

Exclusion Criteria:

* previous cervical spine surgery, cervical spine deformity, pregnancy
Human Papillomavirus (HPV) Infection in Pregnancy

The purpose of this study is to determine if maternal infection with human papillomavirus (HPV) is associated with pregnancy complications including spontaneous preterm delivery (sPTD), severe preeclampsia (PE), and poor fetal growth.


Eligibility Criteria:
Inclusion Criteria:

* All women presenting for prenatal care at the Hospital of the University of Pennsylvania or affiliated clinics

Exclusion Criteria:

* Multiple gestations
* Medical conditions such as diabetes, chronic hypertension, renal disease
* Fetal malformations or chromosomal anomalies
* Fetal death
Low and High Dose Zonisamide in Children as Monotherapy

The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.


Eligibility Criteria:
Inclusion criteria:

1. Pediatric patients with epilepsy whose age is 2\~15 years old.
2. Patients had at least two seizures for the last 6 months before entry.
3. Patients who had never taken antiepileptic drugs.
4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
5. Agreement of the guardian is needed.

Exclusion criteria:

1. Patients who have progressive central nervous system (CNS) disease.
2. Patients with serious disorder.
3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[SGOT\]) or (serum glutamic pyruvic transaminase \[SGPT\]) values more than twice the normal values.
4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
5. Hemolytic anemia.
Moxibustion Reduces Symptoms and Improves Quality of Life in Patients With Allergic Rhinitis

The objective of this randomized controlled clinical trial is to compare the therapeutic effect of moxibustion on allergic rhinitis. The main questions it aims to answer are:

Based on randomized controlled trials, verify the effectiveness of moxibustion in treating allergic rhinitis Based on a real-time monitoring system for human surface temperature, discuss the differences in therapeutic effects of different moxibustion doses on allergic rhinitis

Allergic rhinitis has a high incidence and is difficult to cure, seriously affecting the quality of life of patients Compare the effects of different moxibustion durations on the clinical efficacy and body surface temperature of patients with allergic rhinitis, and preliminarily explore the impact of different moxibustion doses on the efficacy of heavy moxibustion treatment for allergic rhinitis, providing evidence-based basis for clinical practice.

Eligibility Criteria:
Inclusion criteria

* Those who meet the diagnostic criteria of Chinese and Western medicine for AR;
* Age range from 18 to 75 years old, regardless of gender;
* Patients and their families are informed and agree to the study.

Exclusion criteria

* Those who are undergoing other traditional Chinese medicine external treatment methods;
* Those who have taken traditional Chinese medicine recently or during treatment;
* Individuals who are allergic to heavy moxibustion smoke and dust;
* Individuals with concomitant bronchial asthma or other respiratory system diseases;
* Patients with severe skin diseases or ulcers in the local area where moxibustion is applied;
* Pregnant and lactating patients;
* Patients with severe diseases of important organs such as the heart, liver, lungs, and kidneys;
* Those who are unable to receive treatment according to regulations due to inconvenience in work, study, transportation, or personal activities
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B

Nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia B. The current single country, multi-centric, open label, non-randomized clinical trial is a post-approval study to fulfill the Central Drugs Standard Control Organization (CDSCO) request for supplementary information relating to the use of nonacog alfa in Indian subjects with hemophilia B.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥12 years to ≤65 years with a diagnosis of congenital moderately-severe to severe hemophilia B (FIX activity ≤2%).
2. Documented history of at least 50 exposure days (EDs) to FIX-containing products.
3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. For minors under the age of legal consent in India, assent of the participating child needs to be documented for the age range 12 to 18 in addition to the parental informed consent.

Exclusion Criteria:

1. Prior history of inhibitor to FIX or positive inhibitor testing (≥0.6 BU/mL) during Screening. Clinical signs or symptoms of decreased response to FIX.
2. Known hypersensitivity to the active substance or any of the excipients.
3. Known allergic reaction to hamster proteins.
4. Presence of any bleeding disorder in addition to hemophilia B.
5. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation.
6. Planned surgery within 6 months from the start of the study.
7. Unsuitable to participate in study for any other reason as assessed by the investigator; including any disorder, except for conditions associated with hemophilia B, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
8. Subjects (or a legally acceptable representative) is not able to understand study documents and study procedure.
9. Immunocompromised subjects due to human immunodeficiency virus (HIV) infection (defined as viral load above or equal to 100,000 copies/mL; and for HIV+ subjects: cluster of differentiation 4 positive (CD4+) lymphocyte count below or equal to 200/μL). HIV status and CD4+ lymphocyte count results may be obtained at screening or from available medical records; results must be not older than 6 months prior to screening.
10. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, subjects who have been previously enrolled into the study, or subjects who are Pfizer employees directly involved in the conduct of the study.
11. Planned use of any non-study medication for treatment of hemophilia (eg, other factor replacement agents, bypassing agents, or non-factor treatments \[such as anti-tissue factor pathway inhibitors\]).
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning \& evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant at least 12 months prior to enrollment.
* Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

* Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
Lubiprostone in Children With Functional Constipation

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Dose administration details:

* Participants with a body weight \<50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
* Participants with a body weight \>50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Eligibility Criteria:
Inclusion Criteria:

* Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
* At least 6 years of age but less than 18 years of age at the time of randomisation
* Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants

Exclusion Criteria:

* Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
* Untreated faecal impaction at the time of screening
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Comprehensive Risk Assessment of People With Silicosis: A Population-based Study

Objectives: This study aims to explore the risk profiles among people with silicosis in Hong Kong underpinned by the Pittsburgh Mind-Body Center model.

Design and subjects: This study will adopt a cross-sectional study design with sampling stratified by participants' degree of incapability. 320 Chinese people diagnosed with silicosis and registered with the Pneumoconiosis Compensation Fund Board will be recruited.

Data collection: A demographic data sheet and the St. George's Respiratory Questionnaire will be used to collect the socio-demographic and clinical characteristics of the participants. The behavioral factors (smoking, drinking, physical activity level, consumption of vegetable and fruits and plasma vitamin C level) as well as the psychological risk factors (anxiety and depressive symptoms, and social support) will be examined by validated questionnaires. Biological and physiological parameters, including insulin resistance, C-reactive protein, hemoglobin, fasting blood glucose and lipid profiles, will be ascertained by fasting blood sample.

Data analysis and expected outcomes: The findings of this study will create the database profile of the physical, psychosocial and disease specific aspects among people with silicosis in Hong Kong, subsequently forming the empirical basis of an intervention to tackle the identified modifiable risks among them.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese-speaking residents and Chinese ethnicity;
* diagnosis of silicosis and confirmed by the Pneumoconiosis Medical Board
* registered with the Pneumoconiosis Compensation Fund Board (PCFB); and
* able and willing to give informed written consent

Exclusion Criteria:

* With medically diagnosed mental illness, including major depression, or
* with active pulmonary tuberculosis
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin

Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent;
2. Males or females aged 18-75 years of age inclusive;
3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
4. HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
5. Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;
6. DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.

Exclusion Criteria:

1. Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
2. Skin conditions in the area affected by neurupathy that could alter sensation.
3. Chronic systemic diseases that may affect subjects' participation in the study.
4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:

   1. Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L;
   2. AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN;
   3. Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2;
   4. Creatine kinase \> 2.0 × ULN.
5. History of substance abuse or alcohol abuse.
6. Acute complications of diabetes in the 6 months prior to screening.
7. Any active infections at screening.
8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
9. Inability or unwillingness to discontinue any other prohibited concomitant medications.
10. History of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine or related compounds.
11. History of suicidal behavior or attempted suicide.
12. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period.
13. Participated in another clinical study within 30 days prior to screening.
14. Other conditions of the subjects who are unlikely to comply with the protocol.
15. The investigators determine that there are other conditions that are not suitable for participation in this study.
MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

Modern neurorehabilitation is a set of basic and adjuvant treatment methods that provide a modulating effect on the neurorestoration process. The range of basic rehabilitation practices includes kinesiotherapy, occupational therapy, speech therapy, and neuropsychology. Adjuvant methods include physiotherapeutic and medicinal methods. For this study, the investigators chose MEXIDOL® as an adjuvant metabolic medicine, which has the ability to modulate receptor complexes of brain membranes, in particular benzodiazepine, GABA, acetylcholine, enhancing their ability to bind to specific ligands. This pharmacodynamic feature of the drug can have a positive effect on the psycho-emotional state of patients, which in turn will increase motivation and, consequently, the success of the rehabilitation process

Eligibility Criteria:
Inclusion Criteria:

* Acute Ischemic Stroke
* Montreal Cognitive Assessment (MoCA) test \>15; ≤22

Exclusion Criteria:

* Under 18 years old
* Epilepsy
* Pregnancy
* Acute failure of one or more organ systems
* Purulent-inflammatory disease of any localization
* Participating in any other clinical trial