cyrilzakka/clinical-trials huggingface dataset:
Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study

Do peripheral nerve blocks work shorter if you are on opioids?

Background:

Peripheral nerve blocks effectively alleviate postoperative pain. Animal studies and human research indicate that opioid tolerance results in reduced effectiveness of local analgesics. This applies to both central nerve blockade and infiltration anaesthesia. The impact on peripheral nerve block in humans has not been evaluated. The aim of the study is to assess the onset time and duration of a radial nerve block in opioid tolerant individuals compared to opioid naive individuals. We hypothesise that peripheral nerve blocks cause shorter sensory and motor block in opioid-tolerant compared to opioid-naive counterparts.

Methods:

Twenty opioid-tolerant individuals will be matched by sex and age with opioid-naïve counterparts. Participants will undergo an ultrasound-guided radial nerve block. The onset time and duration of motor and sensory blockade will be tested and measured. The primary outcome is difference in duration of sensory nerve blockade between the two groups. The secondary outcomes include the onset time of sensory blockade, onset time of motor blockade, and difference in duration of motor nerve blockade.

Perspectives:

The data from this study will provide evidence for the duration of peripheral nerve block in opioid tolerant individuals and support if a specific postoperative protocol for opioid tolerant individuals is needed or it should be of special attention.


Eligibility Criteria:
Inclusion criteria for opioid group

* Age \> 18 years old
* ASA 1-3
* Chronic pain, defined as persisting pain for more than three months
* Daily use of more than 60 mg of morphine equivalent in more than 7 days
* Legally competent and able to give informed consent

Inclusion criteria for the opioid naive control group

* Age \> 18 years old
* ASA 1-3
* No use of opioids within 30 days prior to participation
* Legally competent and able to give informed consent

Exclusion Criteria:

* Age \> 84 years old
* Volunteers who cannot cooperate with the study
* Volunteers who cannot understand or speak Danish
* Allergy to the lidocaine or the preservatives used in the study
* Alcohol or drug abuse other than opioids
* Peripheral neuropathy at the upper limb non-dominant arm
* Pathology or previous major surgery to the upper limb
* Active signs of infection in the cutaneous area of injection
* Pregnancy at the time of the trial
* Partial or complete 2nd or 3rd degree atrioventricular heart block without a pacemaker
* Severe liver disease
* Severe kidney disease and reduced kidney function (eGFR below 30 mL/min)
* Daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
* Daily treatment with class III antiarrhythmics e.g., amiodarone.
Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children

The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households.

To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high.

hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?


Eligibility Criteria:
Inclusion Criteria:

* All children under five years of age in the randomly selected clusters of Kersa district

Exclusion Criteria:

* seriously sick children in the randomly selected clusters of Kersa district
Intranasal Oxytocin and Learning in Autism

The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.

Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 12-17 years, Mental age ≥ 10
2. Gender: males
3. Diagnosis of an Autism Spectrum Disorder
4. Consent: parent/guardian permission and child assent.
5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
6. Study participant needs to be clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.

Exclusion Criteria:

1. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss).
2. Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
3. Sensory impairments (e.g., significant vision/hearing loss).
4. Gestational age below 35 weeks and/or perinatal injury.
5. Profound mental retardation (e.g., Intelligence quotient (IQ) \< 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
6. Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
7. Female participants.
8. Patients who are sensitive to Syntocinon or any components of its formulation.
9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension

Hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. It is the leading risk factor of cardiovascular disease.

Berberine (BBR) hydrochloride is an isoquinoline alkaloid (chemical formula: C20H18NO4) extracted from traditional Chinese herb Coptis chinensis. It has been widely used to treat diarrhea and enteritis for hundreds of years in China. BBR has extremely high clinical application value. It is an over-the-counter drug with low price, good safety and few adverse reactions in China.

We found that Berberine (BBR) hydrochloride tablets have a hypotensive effect in clinical practice. However, there are few clinical studies on the treatment of hypertensive patients with BBR tablets. In addition, the clinical dosage of BBR tablets is not uniform, and its molecular mechanism is still unclear.

In order to further evaluate the clinical efficacy of BBR in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population.

After signed the informed consent, the subjects are assigned to the lifestyle intervention group (CON) and berberine hydrochloride group (BBR). The berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . We will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.


Eligibility Criteria:
Inclusion Criteria:

1. Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
2. 18 to 75 years old
3. No drugs or dietary supplements that affect blood pressure and vascular endothelial function have been used in the past 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants
4. Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of the study, characters of the disease, drug effects, methods of related examinations, and potential risk/benefits of the study

Exclusion Criteria:

1. Individuals with secondary blood pressure rise factors
2. Individuals who are hypersensitive or intolerant to the drugs
3. Individuals presenting severe constipation
4. Individuals with severe heart disease, abnormal liver and kidney function, acute and chronic infections, autoimmune diseases and patients with any history of cancer
5. Individuals with mental diseases who are not able to cooperate
6. Pregnant women, women during breast-feeding period, or women with expect pregnancy
7. Individuals with hemolytic anemia and glucose-6 phosphate dehydrogenase deficiency
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* Disease progression during or after previous 1st line chemotherapy
* Scheduled to receive 2nd line chemotherapy.
* Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
* 18 years of age or older
* ECOG performance status of 0-2
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy or radiotherapy
* Insufficent renal function (creatinine clearance \< 60ml/min)
* Clinically unstable brain metastasis
* Pregancy or lactation
* History of other malignancy within last 5 years.
Pre/Term Milk Profiling

This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins


Eligibility Criteria:
Inclusion Criteria:

* Having obtained informed consent
* Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks
* Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks
* Age: Mother ≥ 18 years old
* Partial or total breast feeding
* Having a freezer compartment at home (approx. -18°C)
* Good understanding of the French language

Exclusion Criteria:

* Suffering from diabetes (type I or II) before pregnancy
* Alcohol consumption: more than 1 standard drink / day
* Drug addicted
* Subject who cannot be expected to comply with the study procedures.
* Currently participating in an interventional therapeutic clinical trial
DECT Ventilation Imaging

Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation.

Two different clinical situations will be tested :

* Prediction of postoperative pulmonary function for oncologic patients
* Detection of Bronchiolitis Obliterans in lung transplant recipients.


Eligibility Criteria:
Inclusion criteria:

For oncologic patients :

* Potentially operable lung tumor
* With a recent (less than 1 month) V/Q scan

For lung transplant recipients :

* Single of bilateral lung transplant
* From 5 months onwards
* With recent (less than 1 month) respiratory functional explorations

Exclusion criteria:

* Impossibility to follow simple orders or control one's respiration
* Known Krypton hypersensitivity
* History of malignant hyperthermia
* Increased intracranial pressure
* Minors
* Pregnant Women
a Pilot Study of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery

patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery

patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery. Subsequently, all subjects will receive an analgesic device named Patient-Controlled Intravenous Analgesia pump, briefly, PCIA pump during the first 72 postoperative hours. PCIA pump contains lidocaine 30mg/kg, sufentanil 2 μg/kg, and granisetron 12 mg diluted to 200 mL in 0.9 % normal saline, while in the placebo group, the lidocaine will be replaced with the equal dose of 0.9% normal saline and other components unchanged. All the background infusions of PCIA will be set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old；
* American Society Anesthesiologygist(ASA)I\~III；
* Patients scheduled for colorectal cancer surgery；
* The surgery takes more than two hours

Exclusion Criteria:

* BMI≥30kg/㎡or BMI≤18kg/㎡；
* Combined with other organ malignancies；
* Chronic opioid use, substance abuse, contraindication to the use or incompatibility of any drug in the study；
* Patients with liver and kidney insufficiency and chronic pain at the surgical site；
* Accompanied by severe heart disease (such as severe atrioventricular block, severe heart failure, etc.)；
* A history of uncontrolled seizures or acute porphyria；
* Patients who have taken other experimental drugs or participated in or are participating in other clinical trials within 3 months before being enrolled in the study
Laser Treatment of Moderate to Severe Acne Vulgaris

In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
2. In good general health, based on answers provided during the screening visit;
3. Subject must be able to read and understand English;
4. Any gender and any Fitzpatrick skin type;
5. Ages 18 through 40;
6. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)
7. Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;
8. Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).

Exclusion Criteria:

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Currently undergoing or wish to begin or continue topical treatments;
3. Are pregnant or lactating;
4. History of allergic reaction to topical anesthesia;
5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
6. Currently take oral antibiotic or oral therapy for acne;
7. History of keloidal or hypertrophic scarring;
8. Laser treatment in past six months;
9. History of poor wound healing;
10. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Burn Wound Management of Betafoam® and Allevyn® Ag

This is a randomized, controlled, multi-centre, open-label study.

A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 19 years
2. Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
3. Burn total body surface area of \<15% range based on Lund and Browder chart presenting at the emergency room within the first 3\~5 days post-injury will be considered for inclusion in this study.

   (If more than one burn wound is present that meets the inclusion criteria, the largest one among wounds that size are between 10x10 ㎝ and 20x20㎝ will be preferred to select as the Target wound.)
4. Subjects who voluntarily sign the informed consent form

Exclusion Criteria:

1. Pregnant \& lactating females
2. Known allergy to the dressing product including PVP-I
3. Known hyperthyroidism or other acute thyroid diseases
4. Subject with clinical infection who should be administered antibiotics continuously after enrolment
5. Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
6. Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
7. Subject has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that presumably to hinder the wound healing processes by the physician's judgement.
8. Subjects who are immune suppressed states, under chemo- or radiotherapy.
9. The surgeon decides that surgery is necessary or requiring skin grafting.
10. Burn injury sites at the ends of extremities and genitalia
11. Burn injury caused of electronic burn
12. Subjects who have inhaled damage, severe head injury or fracture on burn wound
13. Scintillation scan for the diagnosis of thyroid takes at intervals of 1 to 2 weeks when using this dressing
14. Vulnerable subjects.
CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors

This study aimed to explore the long-term outcomes of CT-guided radioactive iodine-125 (I-125) seed implantation (RISI) for recurrent desmoid tumor.

A multicenter retrospective study reviewed 38 recurrent desmoid tumor patients receiving RISI from July 2013 to July 2021.The clinical outcomes including overall response rate (ORR), disease control rate (DCR), local control time (LCT), overall survival (OS), adverse events (AEs), and symptom relief rate were statistically assessed.

Desmoid tumor was characterized by a high potential of recurrence even following initial definitive treatment. There were considerable controversies regarding the management of recurrent desmoid tumor. This study aimed to explore the long-term outcomes of CT-guided radioactive iodine-125 (I-125) seed implantation (RISI) for recurrent desmoid tumor.

38 patients, diagnosed with recurrent desmoid tumor, undergoing RISI in 3 different centers including Peking University Third Hospital, First Affiliated Hospital of the Army Medical University, and Shengli Oilfield Central Hospital from July 2013 to July 2021 were reviewed consecutively.

The clinical outcomes including overall response rate (ORR), disease control rate (DCR), local control time (LCT), overall survival (OS), adverse events (AEs), and symptom relief rate were statistically assessed.

Eligibility Criteria:
Inclusion Criteria:

1) recurrent desmoid tumor confirmed by pathologic or imaging diagnosis; 2) disease size ≥1 cm and ≤ 10 cm; 3) medically inoperable or individual refusal to resection; 4) Karnofsky performance status (KPS) ≥ 60; 5) adequate hematological reserves, hepatic function, renal function and heart function; 7) expected survival \> 3 months.

Exclusion Criteria:

1) unconfirmed mass; 2) tumor invading the skin or mucous membrane; 2) patients with severe bleeding tendency; 3) patients with active infectious disease, trauma and severe wounds; 4) patients with any mental disorder; 5) patients with other somatic comorbidities of clinical concern; 6) pregnancy and lactation
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA) versus image-guided percutaneous radiofrequency ablation (RFA) in treating aldosterone-producing adenoma.

The objectives of this study are to

1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma.
2. compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.


Eligibility Criteria:
Inclusion Criteria:

1. Hypertensive individuals
2. Biochemically confirmed primary aldosteronism
3. Radiologically confirmed unilateral adrenal adenoma ≤3cm

Exclusion Criteria:

1. Bilateral adrenal disease
2. Multiple adrenal tumors
3. Other concomitant adrenal diseases
4. Potentially malignant adrenal tumors as shown on imaging
5. Uncorrected coagulopathy
6. Surgically unfit for general anaesthesia
7. Prior open abdominal surgery