cyrilzakka/clinical-trials huggingface dataset:
A Study on Probiotic Formula in Autistic Children

A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 3-11 years old
* Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
* With guardians who can fully understand the informed consent and voluntarily sign the written informed consent

Exclusion Criteria:

* Antibiotics or probiotics used within 1 mont
* Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
* Medications related to mental disorders or depression
* Relying on tube feeding
* Swallowing dysfunction that unable to take capsules
* History of severe allergies
* Paticipation in other clinical studies within 4 weeks
* Poor compliance and have difficulty in completing follow-up.
A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis

This non-interventional, retrospective, cross sectional chart review study will evaluate the management of rheumatoid arthritis patients with a biologic in monotherapy. Data from eligible patients will be collected from the patient's last visit on the prior rheumatoid arthritis treatment and from the most recent visit for the biological monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis by a Rheumatologist
* Patient being prescribed with a biologic in monotherapy

Exclusion Criteria:

* N/A
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.

To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria for inclusion in the study.

  1. Unicompartmental, NIDJD, including OA, traumatic arthritis, or avascular necrosis.
  2. Eighteen (18) years of age or older at the time of surgery.
  3. Skeletally mature in the judgement of the PI.
  4. Has met an acceptable preoperative medical clearance and is free of (or acceptably managed) cardiac, pulmonary, hematological, infection, or other conditions that would pose an excessive operative risk.
  5. Willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
  6. Consented to participate in the study by signing the EC-approved ICF.

     Exclusion Criteria:
* Subjects meeting any of the following criteria must be excluded from participation in the study.

  1. Correction of functional deformity.
  2. Revision procedures where other treatments or devices have failed.
  3. Treatment of fractures that are unmanageable using other techniques.
  4. Inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia.
  5. Body Mass Index (BMI) \> 40.
  6. Collateral ligament insufficiency.
  7. Active infection, treated or untreated, systemic or at the site of the planned surgery or previous intra-articular infections.
  8. Incomplete or deficient soft tissue surrounding the knee.
  9. Conditions that may interfere with the UKA survival or outcome, including but not limited to Paget's disease, Charcot disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease.
  10. Diagnosis of an immunosuppressive disorder.
  11. Known allergy to study device or one or more of its components.
  12. Pregnant or planning to become pregnant during the course of the study.
  13. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation
Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.

This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.

Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.

The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COPD in stages GOLD IV
* Receiving optimized medical treatment and long term oxygen treatment, if indicated
* Patient's consent to participate in this trial

Exclusion Criteria:

* Previous treatment with NIPPV
* Unwillingness or intolerance to perform NIPPV
* Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,
* Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training
* Poor controlled coexisting psychiatric or unstable cardiac disease,
* Inability to perform a six minute walk test
* Extreme hypercapnia (pCO2 \> 74 mmHg)
PD-L2 Targeting Nanobody Radiotracer for PET Imaging of Solid Tumor

The objective of this study is to construct a noninvasive approach using 68Ga- Mirc415 PET/CT to detect the PD-L2 expression of tumor lesion in patients with colorectal cancer, lung cancer and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75, male and female, with ECOG score of 0 or 1;
2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
3. The expected survival was more than 26 weeks;
4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \>= 4.0 x 10\^9/L or neutrophil \>= 1.5 x 10\^9/:, PLT \>= 100 x 10\^9 / L, Hb \>= 90g / L; Pt or APTT \<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \<= 1.5 x ULT (upper limit of normal value), ALT / AST \<= 2.5 upper limit of normal value or \<= 5 x ULT (subject with liver metastasis), ALP \<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \<= 4.5 upper limit of normal value); BUN \<= 1.5 x ULT, SCR \<= 1.5 x ULT;
5. According to RECIST1.1, there was at least one measurable target lesion;
6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria:

1. The function of liver and kidney was seriously abnormal;
2. Preparation for pregnant, pregnant and lactating women;
3. Inability to lie flat for half an hour;
4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial. -
Role of IMP3 Expression in Colorectal Carcinoma: An Immunohistochemical Study

Colorectal carcinoma (CRC) is the third most common malignancy worldwide. In Egypt, the relative frequency of CRC is about 9-12% with high male predominance 3:1. The high mortality rates associated with CRC is reflective of several factors including: the lack of apparent symptoms in the early stages and the absence of cancer prevention strategies in developing countries.

Insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a member of the IMP family which plays a key role in the transfer and stabilization of mRNA, cell growth, and migration during embryogenesis. IMP3 has gained considerable interest as a cancer-associated protein. Previous studies strongly suggest that IMP3 may represent a valuable prognostic marker in human cancer. Its overexpression has been reported in a variety of human types of cancer, including lung cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, and breast cancer

Colorectal carcinoma (CRC) is the third most common malignancy worldwide. In Egypt, the relative frequency of CRC is about 9-12% with high male predominance 3:1. The high mortality rates associated with CRC is reflective of several factors including: the lack of apparent symptoms in the early stages and the absence of cancer prevention strategies in developing countries.

Insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a member of the IMP family which plays a key role in the transfer and stabilization of mRNA, cell growth, and migration during embryogenesis. To date, there are three known members of IMP family proteins: IMP1, IMP2, and IMP3 . IMP3 has gained considerable interest as a cancer-associated protein. Previous studies strongly suggest that IMP3 may represent a valuable prognostic marker in human cancer. Its overexpression has been reported in a variety of human types of cancer, including lung cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, and breast cancer

It has been reported that IMP3 expression, determined via immunohistochemistry (IHC), has prognostic significance in CRC, recent studies revealed that IMP3 expression in tumor cells is a marker of poor prognosis in CRC patients and promotes tumor cell proliferation, adhesion, and invasion. Despite these observations, the IMP3 expression and its clinicopathologic significance in human CRC needs further elucidation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CRC and will be underwent surgery.

Exclusion Criteria:

* - Patients received pre-operative chemotherapy or radiotherapy.
* Patients with insufficient clinical data.
A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* A man who is sexually active with a woman of childbearing potential, and has not had a vasectomy with confirmation of azoospermia, must agree to use a barrier method of birth control during the study and for 3 months after receiving the last dose of study drug, and his female partner must also use a highly effective form of birth control at least one month prior to the first study dose and continuing until 3 months after the final study dose. Acceptable barrier methods are male condoms with spermicide, and for the female partner a diaphragm or cervical cap with appropriate spermicidal foam, cream, or gel. Highly effective forms of birth control for the female partner are prescribed hormonal implants, contraceptive patches, contraceptive injections, oral contraceptives, and intrauterine device (IUD)
* Body Mass Index (BMI; weight/height\^2 \[kilogram per meter square {kg/m\^2}\]) between 18.0 and 30.0 kg/m\^2 (inclusive), and body weight not less than 50.0 kilogram (kg)
* Blood pressure (BP) (after the participant is standing for 3 minutes, supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic (orthostatic cut-off, a fall in systolic BP of at least 20 mmHg or diastolic BP of at least 10 mmHg when a person assumes a standing position is exclusionary). If BP is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

* Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening (and at admission to the study center) as deemed appropriate by the investigator
* Known allergy, hypersensitivity, or intolerance to JNJ-42165279 or its excipients
* Any Grade 2 laboratory toxicity
* History of clinically significant drug and/or food allergies
* History of epilepsy or fits or unexplained black-outs
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.

Eligibility Criteria:
Inclusion Criteria:

* • Subject must be at least 18 years of age

  * Subject understands and provides written informed consent
  * Subject who is clinically indicated and will have an attempt of at least one SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent
  * Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Exclusion criteria are not required in this study which is an "all comers" study.
Reducing the Unnecessary Use of Heavily Marketed Medications: A Randomized Controlled Trial

Prescribing decisions by clinicians are often thought to be simple: a patient's clinical problem leads a prescriber to choose the optimal treatment. However, many factors other than the patient's condition affect prescribing decisions, including the marketing of pharmaceuticals. Clinicians are subjected to direct "detailing" by representatives of the pharmaceutical industry, advertisements in medical journals and requests for specific treatments from patients, who are increasingly exposed to direct-to-consumer (DTC) advertising. These influences, often based on biased or inaccurate information, contribute to a variety of problems in prescribing, including the unnecessary use of expensive, heavily marketed medications.

Overcoming these influences requires innovative approaches. The movement toward widespread adoption of electronic health records (EHRs) and electronic prescribing presents new opportunities to educate both clinicians and patients at the time of medication prescribing. This project, endorsed by the AHRQ-supported Centers for Education and Research on Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims to test the effectiveness of computerized prescribing alerts and state-of-the-art educational outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to improve clinicians' knowledge of industry marketing practices, so that they can more effectively assess information provided by drug companies. Thus, the study has two specific aims:

Specific Aim 1: To assess whether computerized prescribing alerts linked electronically to patient educational material can reduce prescribing of heavily marketed medications.

Specific Aim 2: To assess whether group academic detailing increases clinicians' knowledge about industry marketing practices and increases the effect of prescribing alerts.


Eligibility Criteria:
Inclusion Criteria:

* Internal medicine clinicians

Exclusion Criteria:

* none
Combination Therapy With Two Biologicals

The efficacy and safety of dual biological therapy.

Data of all patients treated with the combination of two biologicals in four Finnish tertiary centres were collected and analysed. Inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. The primary outcome was effectiveness, defined as remission assessed by physician after at least four months of DBT. The secondary outcome was safety defined by any adverse events or infection complications during DBT.

Eligibility Criteria:
Inclusion Criteria:

* Simultaneous use of two different biological treatments for IBD.
* Treatment duration with combination therapy for at least for induction period.

Exclusion Criteria:

-Age under 16 years.
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)

01.21 SiroSkin is a phase 3, double-blind, multi-centre, parallel-arm, randomised, placebo-controlled trial to evaluate the use of topical 1% sirolimus in the chemoprevention of skin cancer, versus placebo, applied every night for 24 weeks in solid organ transplant recipients.

Keratinocyte carcinomas are a major burden affecting mortality and morbidity in solid organ transplant recipients (SOTRs). Due to an increased prevalence of skin cancers, SOTRs require recurrent skin checks and frequent skin cancer surgery. The gold standard of treatment is surgery, enabling complete remission and a cure in the majority of cases. Despite this, there is no effective way of preventing new cancers from developing in the same area.

Oral sirolimus is a selective immunosuppressant agent which has proven to reduce the burden of skin cancer; however, it is poorly tolerated due to side effects. Topical sirolimus has proven effective in reducing the skin cancer burden in animal models and is safe on the face of patients with tuberous sclerosis. An initial 12-week phase II clinical trial recently conducted by the research team suggested topical sirolimus to be safe and effective, as it reduced the early signs of skin cancer without any major side effects.

In this phase III randomised, double-blind, placebo-controlled study, we propose using 1% topical sirolimus applied to the face on a regular basis for 24 weeks. We aim to determine whether this topical cream can fill a major gap in our current therapies by reducing the onset of new skin cancers and therefore reduce the burden of disease in terms of number of biopsies and surgeries, and potential hospitalisations and death.

Eligibility Criteria:
Inclusion Criteria:

1. Be aged 18 years or older and able to provide consent
2. Have received an organ transplant equal to or greater than 12 months prior to consent
3. Have had at least 1 SCC/BCC in the past 5 years
4. Have at least 5 keratotic lesions on their face at inclusion

Exclusion Criteria:

1. Are currently receiving sirolimus or everolimus orally\*
2. Have a skin cancer on their face requiring excisional surgery\*\*
3. Have an open wound on their face requiring treatment
4. Are pregnant or planning to become pregnant in the next 6 months
5. Anticipate elective medical events which may prevent daily cream application.
6. Are unable to provide informed consent, complete questionnaires and attend trial site for visits
7. Are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression
8. Planning to move overseas within 2 years

(\*)Patients are eligible to join the study after ceasing treatment and after a washout period of 16 days for sirolimus and 8 days for everolimus.

(\*\*) Once treatment of the lesion is completed these patients can be re-screened.
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe

The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

rosuvastatin and ezetimibe(anti-dyslipidemia)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria:

* subjects have a history of allergy reaction of this drug or other drugs