cyrilzakka/clinical-trials huggingface dataset:
Cognitive Correlates of Antidepressant Treatment Response in Elders

Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* above the age of 65,
* speak English fluently,
* experience depression, AND
* not yet on active treatment.

Exclusion Criteria:

* active delirium,
* substance abuse,
* mental illness other than major depression,
* active CNS disease,
* unstable systematic medical disease, OR
* current of past psychotic disorder.
A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic hepatitis C, genotype 1;
* treatment-naive.

Exclusion Criteria:

* liver cirrhosis and other forms of liver disease;
* HIV infection;
* hepatocellular cancer;
* cardiac disease.
Registry and Clinical Observation of Children With Diarrhoeal Disease

This Study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea Therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and therapeutic effect of childhood diarrhea, safety monitoring data, and provide reliable data support for the clinical application.

To evaluate the causes, clinical manifestations, treatment plans and clinical outcomes of diarrhoeal disease in children in a real diagnosis and treatment setting。 Evaluate the effect of different treatment schemes in actual clinical application,the clinical use of nutrition-supported zinc in oral rehydration fluids,the influencing factors of clinical efficacy, including the demographic characteristics and clinical characteristics of the children, as well as drug combination regimens, etc. To evaluate the clinical use of antibiotics,the clinical effects of different probiotics in the treatment of diarrhoeal disease in children,the effectiveness, safety and economy of the dose course of the clinical application of Clostridium butyricum bivariate living agents, the medical costs and resource consumption of treatment for diarrhoeal diseases in children.

Eligibility Criteria:
Inclusion Criteria:

* Under the age of 18

  * Children diagnosed with diarrhea, including:

    1. Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors
    2. Persistent chronic diarrhea:

Including the following diseases:

1. Food allergy, food intolerance, indigestion, etc.;
2. Inflammatory bowel disease (IBD);
3. Diarrhoeal irritable bowel syndrome;
4. Antibiotic associated diarrhea (AAD);
5. Others: chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc 3. Volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent

Exclusion Criteria:

1. Class A infectious diseases associated with diarrhoea (cholera, plague)
2. Children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。
3. Children receiving long-term immunosuppressive therapy (except children with IBD)。
4. Children with gastrointestinal surgery and tumor;
5. In addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia

The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years, male or female;
2. Subject meets one of the following conditions:

1) Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.

Exclusion Criteria:

1. Subject who is pregnant or breastfeeding;
2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit;
3. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
4. HbA1c˃8%;
5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
6. Subject with a history of malignancy;
7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen
8. Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;
9. Subject has acute gout flares within 2 weeks before randomization;
10. Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;
11. Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;
12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.
Toviaz Post Marketing Surveillance Study

The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

continuous registration method

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.

Exclusion Criteria:

* Hypersensitivity to the active substance or to peanut or soya or any of the excipients
* Urinary retention
* Gastric retention
* Uncontrolled narrow angle glaucoma
* Myasthenia gravis
* Severe hepatic impairment (Child Pugh C)
* Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
* Severe ulcerative colitis
* Toxic megacolon
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)

This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18-50 years of age who:
* are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
* volunteer for the simulated post-exposure vaccination courses and blood draws;
* have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
* are available for all the visits scheduled in the study.

Exclusion Criteria:

* Subjects with the below criteria were excluded:
* pregnancy or unwillingness to practice acceptable contraception during participation in the study;
* a history of rabies immunization;
* a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
* fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
* treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
* administration of any vaccine within the past 14 days before enrolment;
* known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
* history of allergy to egg protein;
* known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
* treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
* mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
* participation in any other investigational trial within the past 3 months before enrolment;
* planned surgery during the study period;
* intention to leave the area of the study site before the end of study period;
* any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Smartphone App for Analysis of General Movements in Young Infants

Analysis of spontaneous movements in young infants from video recordings is recommended as an early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such video recording have previously been performed in follow-up programs at hospitals using semi standardized video set-ups. The research group behind this study develops a smart-phone application that makes it possible for parents to video film their infant spontaneous movements at home, upload and send the video for analysis at the hospital provided by experts. The objectives of the study are to assess the feasibility of the In-Motion app for video recording of infant spontaneous movements, upload and send the video to St. Olavs Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120 high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will participate. Parents will record their infant spontaneous movements and answer questionnaires. Video quality will be evaluated by experts within the field and their use for computer-based assessment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Infants referred to high-risk follow-up at the hospital

Exclusion Criteria:

* Unstable medical condition, progressive disorders, or diagnosis with a specific syndrome affecting motor development.
Estimating Apnea Phenotypes From Polysomnography: Oxygen

This study seeks to employ advanced methods to estimate the individual factors contributing to sleep apnea from standard recordings made during routine clinical sleep studies. This study focuses on breathing control or "loop gain" as one of the factors contributing to sleep apnea. Increased levels of oxygen in the air is known to make breathing more stable by lowering "loop gain". Here, our goal is to use a new method capable of detecting a reduction in loop gain with oxygen. The investigators also aim to test whether a high loop gain measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen therapy.

In a single-blinded randomized crossover study, inspired oxygen/air (40%/21%) is delivered on two separate nights. Loop gain is measured from routine polysomnography using a novel mathematical method. A value of loop gain \>1 reflects unstable breathing, and a value less than but approaching 1 denotes a system more prone to oscillate. Loop gain is measured as the changes in ventilatory drive/effort that arises subsequent to changes in ventilation (e.g. due to obstructive apnea). A simple chemoreflex model (gain, time constant, delay) is fit to surrogate ventilation data (derived from airflow) during sleep. The best model is one that best matches the elevated ventilatory drive (measured as ventilation in the absence of airflow obstruction) based on the prior apneic/hypopneic fall in ventilation. Loop gain is calculated from this model. We aim to use loop gain measured on and off oxygen to determine whether a strong response (reduction in apnea severity) can be predicted by a higher loop gain (in the sham arm) using our method. We also assessed whether assessing upper airway anatomy/collapsibility, dilator muscle responsiveness, and the arousal threshold helped to predict responses to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Apnea/hypopnea index \>20 events per hour
* Age 20-79 years

Exclusion Criteria:

* COPD with desaturation (resting SpO2\<96%)
* Use of respiratory stimulants or depressants
* Pregnancy
A Study to Evaluate the Safety and Tolerance of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies

This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed/refractory hematologic malignancies confirmed by the World Health Organization (WHO) criteria.
* Eastern Cooperative Oncology Group (ECOG) score ≤ 1.
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Pregnant and lactating females.
* Proven hematologic malignancies of the central nervous system.
* Diagnosed acute promyelocytic leukemia (predominantly granulocytic promyelocytes in bone marrow, which are ≥ 30% in NEC).
* History of other malignant tumors within 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ.
Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers

The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.

The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.

Based on a wait list trial design, and 4 observation points (baseline, post-intervention, 3-month and 6-month follow-ups), the investigators propose to demonstrate the efficacy of this new intervention (Aim 1), and evaluate for potential moderating conditions across subgroups (Aim 2; age, gender, educational level, etc.). Based on this quantitative component, the investigators will answer the following two aims:

Aim #1. (Efficacy) Compared to a waitlist control group, is Unidos efficacious with regards to primary outcomes-PHQ-9 depression symptoms, RMBPC reactivity to memory and behavior problems, anxiety symptoms, and secondary outcomes-caregiver mastery, competence, and meaning over time?

Aim #2: (Moderators). Do moderating conditions exist such that the intervention is more or less efficacious for subgroups based on age, gender, PLWD functioning?

Qualitative component: After class completion, the investigators will draw from 40-50 focus group participants to elucidate the satisfaction and acceptability of the program. Both Unidos and wait list control participants will be randomly selected for focus group interviews which will be guided by open-ended inquiries around the nuanced, in-depth perspectives of program participation, acceptability, and recommendations (Aim 3).

Aim #3: (Experience/Satisfaction). Will qualitative reports from focus groups signal satisfaction, nuanced differences with respect to the nature, structure, cultural/ language considerations of Unidos, and recommendations?

Based on the scientific team and community partner's established expertise in dementia care, caregiving services, and underrepresented groups, the project is well positioned to address the linguistic and cultural preferences and needs of diverse Californians and the providers that serve them.

Eligibility Criteria:
Inclusion Criteria:

* identifies with being Hispanic or Latino descent
* speaks and reads Spanish
* dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California
* who identify as women, men, or non-binary,
* age 18 years or older

Exclusion Criteria:

* Severe sensory or physical conditions that interfere with ongoing participation.
Using Telerehabilitation Tools to Deliver Quality Therapy to Patients Under Infective Isolation Precautions

Single blinded Randomised Controlled trial comparing standard therapy to the intervention of up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. Total recruitment: 60 patients.

This is a single blinded randomised control trial. From August 2018 to March 2019, a total of 60 subjects, who match the inclusion exclusion criteria, will be recruited from patients transferred to the SGH Isolation wards.

They will be randomly assigned to control or treatment arm based on a block randomisation strategy predetermined and held by an independent party.

The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period. They will be evaluated for motor strength, activity of daily living performance, mood and perceived level of health.

The control arm will be subject to the same assessments as the treatment arm at the start and end of the two week period. They will receive standard care in the ward including physiotherapy as prescribed by the managing team.

The assessors will be blinded to the arm of the study the subjects will be assigned to and will be independent of the terating physiotherapist.

1.1. Hypothesis We propose that for patients with deconditioning after a prolonged period of hospitalization and needing inpatient isolation precautions, that a 2-week course of daily, up to 1-hour long, physiotherapist-developed resistive training exercises will result in a 20% improvement in the motor power and a corresponding improvement in motor functioning and the perceived quality of life compared to a control group receiving standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* • Able to give consent

  * Admitted to hospital for at least 5 days
  * MMT power grading 2-4/5
  * Isolated for prevention of transmission of MDROs

Exclusion Criteria:

* • Unable or unwilling to consent for the trial

  * Assessed by managing team to be fit for discharge within the next 2 weeks
  * Pregnant women
  * Underlying medical disorders that result in pre-existing lower limb weakness
Efgartigimod for the Treatment of Guillain-Barré Syndrome

The goal of this clinical trial is to evaluating the efficacy and safety of efgartigimod in the treatment of Guillain-Barré Syndrome and exploring the immunological mechanisms of efgartigimod therapy in Guillain-Barré Syndrome. The main questions it aims to answer are:

Will efgartigimod improve the symptoms of participants? What medical problems do participants have when using efgartigimod?

Participants will:

On day 1 and day 5 of the treatment period, drug A was administered intravenously.

Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older;
2. Meet the diagnostic criteria as specified in the \*European Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2023 Edition\*;
3. Onset of GBS symptoms within 2 weeks prior to enrollment;
4. GBS-DS score of 3-5;
5. Written informed consent obtained.

Exclusion Criteria:

1. Patients with GBS symptoms for more than 2 weeks;
2. Known hypersensitivity of the study subject to any component of the investigational drug or any other anti-neonatal Fc receptor (FcRn) agent;
3. Any uncontrolled active infection or severe infection within 8 weeks prior to screening;
4. Patients with other autoimmune diseases, such as Sjögren's syndrome, systemic lupus erythematosus, neuromyelitis optica, myasthenia gravis, multiple sclerosis, etc., requiring treatment with immunosuppressive agents;
5. Vaccination within 4 weeks prior to screening or planned vaccination during the study period;
6. Pregnant or breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception;
7. Currently participating in another clinical trial of similar investigational agents (FcRn antagonists);
8. Use of the investigational drug within 3 months prior to screening or within five half-lives of the drug (whichever is longer);
9. Patients with a history of malignancy, including malignant thymoma, myeloproliferative or lymphoproliferative disorders, unless considered cured by adequate treatment and without evidence of recurrence for ≥3 years prior to screening. Patients with completely resected non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix are eligible at any time;
10. Patients with clinical evidence of other significant severe diseases or who have recently undergone major surgery, which may confound study results or place the patient at undue risk. Patients with severe renal/hepatic impairment may be included.