cyrilzakka/clinical-trials huggingface dataset:
Beneficial Bacteria Treatment for Autism

This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.

The combination therapy includes beneficial bacteria.

This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.

It involves a combination therapy including beneficial bacteria.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 7-17 years
2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)
3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items
4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial
5. General good physical health aside from gastrointestinal problems
6. Cognitive Ability to Provide Informed Assent

Exclusion Criteria:

1. Antibiotics in last 6 months
2. Probiotics in last 3 months
3. Single-gene disorder (Fragile X, etc.)
4. Major brain malformation
5. Tube feeding
6. Severe gastrointestinal problems that require immediate treatment (life-threatening)
7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
8. Severely underweight/malnourished
9. Recent or scheduled surgeries
10. Current participation in other clinical trials
Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients

The aim of the study is to compare postoperative analgesia in pediatric patients undergoing inguinal hernia repair by comparing the efficacy of ultrasound guided paravertebral block versus ultrasound guided erector spinae plane block.

* To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.
* To measure the time of first request of rescue analgesia and to assess pain intensity at rest (static) and after movement or coughing (dynamic) using 10 points Modified Objective Pain Score (MOPS).
* To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread).
* Over all parent's satisfaction: The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Eligibility Criteria:
Inclusion Criteria:

1 - Parents acceptance

2. Age: preschool and school age child (24 months-12 years old).

3. Sex: both sex (males or females).

4. Physical status: ASA 1\& II.

5. Type of operation: elective unilateral inguinal hernia repair

Exclusion Criteria:

1- Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)

2. Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).

3. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.
cl[Nical Study of Succide Among Patient With Psychoactive Substance Use Disorders

detect risk of suicide among patient with substance use disorder

Substance use disorder (or drug addiction) is a neuropsychiatric disorder characterized by recurring desire to continue taking the drug despite harmful consequences. Substance use disorders are a major risk factor for suicide Suicide is a leading cause of premature death in young adults. Data from the World Health Organization indicate that the rate of completed suicide for the world's population is 16 per 100,000 inhabitants, which means that each year more than a million people in the world commit suicide. Suicide attempts are five to twenty times more common than the completed suicide.Based on the data from the research community, approximately 5% of adults attempts suicide at least once in their lifetime .

Mental health problems are the most common and best explored risk factor associated suicidal ideas, suicide attempts and completed suicide. About 90% of all people who commit suicide met the diagnostic criteria for one or more psychiatric disorders . People who use alcohol and/or drugs or are dependent on them, attempting suicide nearly six times more often than people who do not use these substances. The rate of completed suicide among addicts is 2 to 3 times higher than among the males who are not addictst, while in a few cases the manner in which the suicide is attempted is not directly related to drugs . Although there is a correlation between the disorder caused by the use of substances and suicidal behavior, a large number of addicts will never attempt suicide. It is therefore important to identify those individuals with the disorder caused by the use of substances that may be at higher risk for suicide .

Many risk factors for suicide in the general population also apply to drug addicts. The older drug addicts are at higher risk for attempts and suicides than younger addicts Another very important fact when it comes to suicide attempts is the drug used. It is known that heroin and sedatives are substances with which suicide attempts suicide are most often made, while other drugs are less characteristic .

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling diagnostic criteria of substance use disorder

  1. social impairment
  2. impaired control
  3. risky use
  4. pharmacological indicators (tolerance and withdrawal).

Exclusion Criteria:

* Patient with other psychatric disorders ex schizophrenia, mood disorder
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of single and repeated oral doses of Linaprazan Glurate for up to 14 days at 3 dose levels in healthy male and female subjects.

The subjects will be followed up to 28 days post IMP dosing.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female subject aged 18 to 65 years, inclusive.
3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
4. Medically healthy, without abnormal clinically significant medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

1. Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
2. Male subjects with a partner of childbearing potential
3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
4. History of GERD or clinically significant acid reflux, as judged by the Investigator.
Indoor Air and Children Health Study

The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.

This randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in Beijing. Real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. During the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone, carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. In addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.

Eligibility Criteria:
Inclusion Criteria:

* living in Beijing for more than two consecutive years;
* living in school dormitories from Monday to Friday.

Exclusion Criteria:

* suffering any health condition;
* having asthma or thoracic surgery history.
Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled morphine consumption, rescue analgesic requirement and side-effects were recorded for up to 24 h after the start of patient-controlled analgesia.

Eligibility Criteria:
Inclusion Criteria:

* 60 ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study

Exclusion Criteria:

* severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for \> 3 months), drug or alcohol abuse and contraindication to administration of PCA
Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.

Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.

Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.

Then, propofol and remifentanil infusions were discontinued, and patients were extubated.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
* written informed consent

Exclusion Criteria:

* ophthalmic disease
* neurologic disease
* preoperative chronic pain or pain medication
* medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)
Prefabricated Endodontic Posts: Glass Fiber Versus Titanium - A Randomized Controlled Pilot- Trial

A randomized parallel-group clinical pilot study was designed to evaluate the impact of glass fiber reinforced composite posts compared to prefabricated titanium posts on long term survival of adhesively restored endodontically treated abutment teeth.

Compared to vital teeth the complication rate of restorations fixed on endodontically treated abutment teeth is higher. Endodontically treated teeth are more prone to fracture due to the higher amount of calcified tooth structure loss. To level the biological short coming the choice of the mechanically appropriate post material is still a major concern. There a two major approaches. One is to use a rigid material to stiffen the post-endodontic complex and the other is to use a material which shows dentin-like material properties to allow the post-endodontic complex to flex under load. It was aim of the presented randomised controlled trial to compare the survival rates of abutment teeth self-adhesively restored with either prefabricated glass-fiber reinforced composite posts or titanium posts.

The null-hypothesis was that there is no difference regarding survival rate between glass-fiber and titanium post restored endodontically treated abutment teeth with two or less remaining cavity walls.

Eligibility Criteria:
Inclusion Criteria:

* two or less cavity walls of the crown remaining,
* residual root canal thickness at the orifice of more than 1 mm,
* symptom free tooth with a root canal filling without radiologically visible periapical lesion,
* minimum of radiologic root-to-alveolar bone ratio of 2 after prospective crown lengthening,
* no or treated periodontitis with maximum probing depth of 4 mm and no bleeding on probing,
* tooth mobility not more than score II,
* willingness to return for follow-up examination for at least 5 years

Exclusion Criteria:

* tooth was aimed to serve as telescopic crown abutment
Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots

This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter. The main aim is to validate the clinical performance and safety of the body-worn Fluispotter system used for automated extraction, collection and storage of 20 dried venous dried blood spot samples of 10 µl over the course of 20 hours.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥ 18
* Able to understand verbal and written instructions in Danish
* Able and willing to sign and date the informed written consent form and letter of authority

Exclusion Criteria:

* Currently participating in a clinical trial evaluating drugs or medical devices
* Known history of coagulation disorders
* Currently taking regular medication (contraceptives, hormonal replacement therapy and antihistamines exempted)
* Regular smoking or use of nicotine products
* Pregnancy
* Haematocrit \< 38% (male); \< 33% (female)
* Haematocrit \> 52% (male); \> 48% (female)
* C-reactive protein (CRP) \> 10 mg/dL
* Body Mass Index (BMI) \> 30
* Known allergies or hypersensitivity to flushing solution constituents
* Other factors which in the opinion of the investigator would interfere with the ability to provide informed consent, comply with study procedures/instructions, or possibly confound the interpretation of the study results or put the subject at undue risk
Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer

The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.

Eligibility Criteria:
Inclusion Criteria:

* at least one first degree relative with breast cancer
* age 40 or older

Exclusion Criteria:

* currently taking a menopausal therapy
* previous cancer diagnosis (except basal cell carcinoma)
* previous diagnosis of atypical hyperplasia
* previous diagnosis of lobular carcinoma in situ (LCIS)
* known carrier of a BRCA1 or BRCA2 mutation
* personal history of heart disease
* \>10% risk of carrying a BRCA1 or BRCA2 mutation
To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study

The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).


Eligibility Criteria:
Inclusion Criteria:

* Stable or unstable angina pectoris suitable to PCI of at least one coronary vessel
* Age \>18 years

Exclusion Criteria:

* Recent (\<72 hours) acute myocardial infarction
* Creatinine clearance \<40 ml/min
* Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
* Life expectancy \<1 year
The Safety of Hand Surgery in the Anticoagulated Patient

If operating on the anticoagulated patient has been safe for one of the investigators' surgeons for the past 10 years then providing prospective data that substantiates this could prevent complications related to the discontinuation of anticoagulation for hand surgery patients in the future.

All eligible patients will be offered study enrollment pre-operatively. Demographic data collected during clinical interaction that will be gathered for research purposes and will included patient height, weight, age, anticoagulant medication(s) used with dosage/duration of use, indication for anticoagulant medication, and current INR if on warfarin. Preoperative examination will include measures of 2 point discrimination in the digits, distance of the fingertips from the distal palmar crease upon flexion, and the patient-based outcome surveys that are to be collected after surgery (Quick DASH, SF-12, Visual Analog Scales pain/swelling). These patients will then undergo the appropriate surgical procedure without discontinuing their anticoagulant medication.

To ensure that patients are not being placed at increased risk, this study's protocol will not alter the surgical practices of the attending surgeons involved. Specifically, all surgeons perform their hand and wrist surgery under tourniquet control but differ in whether the tourniquet is deflated prior to wound closure. Each surgeon will be free to manage the tourniquet as they feel appropriate. The placement of would drains will remain at the discretion of the attending surgeon on a case-by-case basis.

Local anesthetics may be injected but none will be mixed with epinephrine.

Procedures: (if applicable) Obtaining pre-operative INR values when appropriate, and performing surgery while continuing anticoagulants is already standard care for one faculty member. All post-operative care except the completion of the Quick DASH and Short Form 12, and visual analog ratings is part of standard clinical care. Research questionnaires should take no more than 20 minutes to complete per visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Taking daily anti-coagulant medication
* Having hand or wrist surgery

Exclusion Criteria:

* Surgery proximal to wrist
* Pregnant females
* INR \> 3.5
Use of PET/MR Imaging in Chronic Pain

The investigators are studying the ability of PET/MR imaging (using the PET tracer \[18F\]FDG) to objectively identify and characterize pain generators in patients suffering from chronic pain.

The diagnosis and management of chronic and neuropathic pain syndromes remains a major clinical challenge, and this failure is partly attributed to our inability to identify the hypersensitive and inflammatory changes in the pain-sensing part of our nervous system that is thought to contribute to these syndromes. The lack of a specific, objective diagnostic test for chronic and neuropathic pain syndromes can result in a delay of diagnosis and suboptimal management decisions. This delay in diagnosis is quite unfortunate since the early diagnosis and treatment of a disease is attributed to the highest probability of remission in certain chronic pain syndromes. Additionally, identifying the correct source of pain is of paramount importance since the clinical course and therapeutic interventions are different depending on cause.

Evidence in the literature points strongly toward an active inflammatory component in chronic pain. For example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. Similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. It is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as \[18F\]fluorodeoxyglucose (\[18F\]FDG). Correspondingly, \[18F\]FDG positron emission tomography-magnetic resonance imaging (PET/MRI) represent leading FDA-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. One of the goals of the study is to determine whether \[18F\]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine.
* Provides informed consent
* On a typical day, pain level of at least 4/10 on a 0-10 Comparative Pain Scale
* Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion Criteria:

* MRI-incompatible
* Diabetes
* Pregnant or nursing
* Non-English speaker
* Claustrophobic