cyrilzakka/clinical-trials huggingface dataset:
BIS Monitoring in Relation to Muscle Relaxant Administration

The purpose of this study is to determine the overall optimal timing of when the Bispectral Index (BIS) monitor should be started: before or after the muscle relaxant is given.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective cardiac surgery
* Muscle relaxation administration by rocuronium

Exclusion Criteria:

* Patient refusal
* Pediatric patients
* Emergency procedure
* Patients with known or suspected carotid or cerebrovascular disease
* Patients with prior stroke
* Skin condition or anatomy preventing proper sensor placement
* Patients who receive ketamine during the study timeframe
Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch

With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.

With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.

The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Electromyographic Response to TsDcs in CNSLBP

The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes.
* Age 18-60 years old.
* Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:
* Chronic low back pain, defined as pain lasting for more than 12 weeks.
* No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).
* No radicular symptoms(e.g. pain radiating down the leg).
* No significant neurological deficits or findings on physical examination(e.g. loss of reflexes or muscle strength).

Exclusion Criteria:

* Previous fractures and/or surgery in the vertebral spine.
* Neuropathic pain extending along the lower limb due to nerve root compression.
* History of spine trauma or fracture.
* Implanted pacemakers.
* Pregnancy.
* Malignancy.
* Systemic musculoskeletal diseases.
* Epilepsy.
* History of psychiatric disorders.
* Obesity
RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

This study was a prospective, single-arm phase II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC combined envafolimab in the first-line treatment of locally advanced or metastatic biliary tract cancer with positive HER-2.


Eligibility Criteria:
Inclusion Criteria:

* 18 years;

  * ECOG 0-1;
  * patients diagnosed by pathological or cytological diagnosis of locally advanced or metastatic biliary tract cancer (include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder and ampullary carcinoma);
  * life expectancy of at least 3 months;
  * HER2 IHC 2+ or 3+;
  * At least one measurable objective tumor lesion according to RECIST 1.1;
  * Not received systemic chemotherapy in the past. Patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial.
  * satisfactory main organ function (laboratory test must meet the following criteria): hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, Serum creatinine (CR) ≤1.5 upper normal limitation (UNL), total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), left ventricular ejection fraction (LVEF) ≥ 50%;
  * Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects;

Exclusion Criteria:

* Previously received drug therapy against PD-1/PD-L1 inhibitor and other Antibody conjugate drug (Such as T-DM1 and DS8201);
* Allergic to the active ingredients or excipients of the study drug;
* biliary obstruction were excluded. Unless blockage is treated locally, such as endoscopic stenting, percutaneous hepatic drainage, etc., total bilirubin is reduced below the upper limit of 1.5 UNL;
* A history of malignancies other than biliary tract malignancies (other than cured carcinoma in situ of the cervix or basal cell carcinoma of the skin and other malignancies cured for 5 years);
* Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture;
* Unsuitable for the study or other chemotherapy determined by investigator.
Efficacy of Rapamycin (Sirolimus) in the Treatment of BRBNS, Hereditary or Sporadic Venous Malformation

A prospective, nonrandomized, open-label, single-arm clinical trial to study efficacy of rapamycin (sirolimus) in the treatment of Blue Rubber Bleb Nevus Syndrome, hereditary or sporadic venous malformation

Blue rubber bleb nevus syndrome (BRBNS) and venous malformation are mainly caused by somatic mutation of TEK and PIK3CA, which activates the PI3K/AKT signaling pathway. As an important protein kinase downstream of the PI3K/AKT pathway, mTOR can serve as a potential therapeutic target for BRBNS. Experiments of mice have shown that rapamycin inhibited the progression of venous malformation lesions. There are a few human cases reported using rapamycin treatment. The investigator's study is designed to be a prospective, nonrandomized, open-label, single-arm clinical trial to investigate its efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with BRBNS, VMCM, sporadic multiple VM, or large single VM;
* Age and gender are not limited;
* Physical status ECOG 0\~3;
* Organ function is good, biochemical examination meets the following conditions: AST ≤ 2.5 × upper limit of normal value (ULN), ALT ≤ 2.5 × upper limit of normal value (ULN), serum total bilirubin ≤ 1.5 × upper limit of normal value (ULN), creatinine ≤ 1.5 × upper limit of normal (ULN);
* Patients volunteer to participate in the trial and sign the informed consent form by the participant or his/her legal guardian.

Exclusion Criteria:

* Patients need emergency surgery due to intestinal obstruction, intussusception, or gastrointestinal bleeding;
* History of surgery within 1 month;
* allergic to rapamycin;
* Any disease or condition that may affect the study implementation or result interpretation, including: known hemoglobinopathy, suffering from gastrointestinal infections at the same time, severe heart, liver, kidney and other serious concomitant diseases that may endanger lives
* Pregnant or lactating women;
* Alcohol or drugs (eg, laxatives) abusers;
* Participating in another clinical trial that may affect this study within one month;
* Being believed not suitable to be enrolled by the investigator for other reasons.

Exit Criteria:

* An allergic reaction to rapamycin occurs.
* The patient requests withdrawal: at his own discretion or at the request of his legal representative. Subjects may refuse to participate in further studies at any time without reasons. Subjects will not be affected because of such decision.
* Subjects are required to withdraw from the study in certain special circumstances (eg, there is significant issues of compliance, safety, or surgical intervention for the disease)
* Other situations in which the study must be terminated. For example, the investigators believe that continuing the study may be harmful to the health of subjects.

Rejection Criteria:

* Patients who violate the requirements of the test protocol
* Patients with poor recording (with incomplete, or inaccurate data)
Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* spherical equivalent ≤ -4.0 D
* cylinder ≤ 1.50 D

Exclusion Criteria:

* history of ocular trauma or surgery
* any corneal and ocular pathologies
* central corneal thickness \< 500 µm
* scotopic pupil diameter \> 6.0 mm
* any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
* the presence of systemic disorders such as collagen vascular diseases
Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.

The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.

Ethanol administration has an effect on vestibular function, measurable with video head impulse test (vHIT)- and vestibulo-oculography (VOG)-methods.

The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, a disease with difficult diagnostics, via ethanol administration in healthy human subjects.

As subjects are consuming ethanol via oral route, vHIT-measurements and VOG-measurements (slow and rapid eye movement recordings) are being recorded in order to measure the change in vestibular function.

During approx. 5 hours, 4 vHIT measurements will take place, while subjects ingest ethanol towards 1 per mille levels, measured via alcoholmeter.

Necessary precautions include strict exclusion criteria regarding health of the subjects and also comprehensive preparedness for management of allergic reactions and other unusual phenomena related to alcohol consumption.

Eligibility Criteria:
Inclusion Criteria:

* no previous ear diseases
* normal hearing
* no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)

Exclusion Criteria:

* previous ear diseases
* abnormal hearing
* signs of alcohol dependence (7 points or more in AUDIT-questionnaire)
Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery with Deep Hypothermic Circulatory Arrest Using Diffusion MRI

Deep hypothermic circulatory arrest (DHCA) (18 degree) without cerebral perfusion is a safe technique. Resarchers use this technique in patients with proximal aortic pathologies.

During the DHCA period, cerebral silent ischemic events may occur. But the silent ischemic events don't neurological problems with patients.

It is important to evaluate neurological functions in patients with ascending aortic and aortic root aneurysms who underwent deep hypothermic circulatory arrest (18 degrees) and did not undergo cerebral perfusion. However, neurological changes that are reflected in the clinic are not always encountered. Using preoperative and postoperative diffusion magnetic resonance imaging, silent ischemic lesions that are not reflected in the clinic can be detected. Although there are studies using DW-MRI in patients undergoing different cerebral protection methods in the literature, there are no studies conducted on patients who underwent deep hypothermic circulatory arrest without cerebral perfusion.

To detect silent ischemic lesions with preoperative and postoperative diffusion magnetic resonance method in patients with ascending aortic and aortic root aneurysms undergoing deep hypothermic circulatory arrest (18 degrees) and without cerebral perfusion, and to investigate the correlation between preoperative and postoperative neuron-specific enolase levels and serbral findings.

Cerebral ischemic lesions that may occur in patients undergoing deep hypothermic circulatory arrest (18 degrees) and undergoing ascending aortic and aortic root aneurysm surgery without cerebral perfusion will be detected, and the clinical follow-up and treatment of the patients will be better managed.

We base the imaging of diffusion MR among the examinations to be performed on literature studies that show that withdrawal of patients in the early postoperative period (3rd-7th days) due to the surgical method to be performed without cerebral perfusion under deep hypothermic circulatory arrest, increases the specificity and sensitivity of the test. Therefore, the application of diffusion MR imaging in the early postoperative period (3rd-7th days) after a surgical technique performed under deep hypothermic circulatory arrest (18 degrees) without cerebral perfusion constitutes an indication for diffusion MR in order to detect cerebral ischemic lesions in the early period. Therefore, diffusion MR imaging to be taken in the early period (3rd-7th days) will provide us with the opportunity to create an effective algorithm in terms of patient treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ascending aorta and aortic root aneurysm.
* 18-85 years old

Exclusion Criteria:

* Patients without ascending aortic and aortic root aneurysms
* outside the age range of 18-85, emergency surgery,
* Exceeding the magnetic resonance imaging extraction time limit.
Malaria Prevention Cambodia

Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.

This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer 18-65 years of age
2. Able to give informed consent
3. Likely to reside in malaria endemic area for the duration of the study
4. Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
5. Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
6. Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

1. Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
2. Significant acute comorbidity requiring urgent medical intervention
3. Positive malaria blood smear.
4. Treatment with an antimalarial drug in the past 30 days.
5. Pregnant or lactating female or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
6. Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
7. Regular current use of known QTc prolonging medications
8. History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
9. Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women

RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria restricted the patients to 39 years old with basal FSH \< 10 IU/ml and normal TSH and prolacin.

Exclusion Criteria:

* Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)
HOME: Home Monitoring of High-risk Pregnancies

High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.The main aims of the HOME study (Home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.


Eligibility Criteria:
Inclusion Criteria:

* Preeclampsia
* Gestational Hypertension
* Premature Preterm Rupture of Membranes
* High Risk Pregnancy
* Previous adverse obstetric outcomes

Exclusion Criteria:

* Multiples (twins, triplets etc)
* Patient or fetus in immediate need for delivery
* Not understanding Norwegian
* Not mastering the technological aspects of home monitoring
* Long travel distance to Obstetric Department
Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.

X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not only the patient, but the personnel of ERCP team may have the effect from the scattered ray. According to the automatic beam adjustment function, the thicker object (eg. lying left lateral) might produce higher scatter ray than thinner object (eg. lying prone). The investigators evaluate the radiation exposure among ERCP personnel compare between patient's 2 different positions.

Personal solid-state dosimeters were used to measure the radiation dose on personnel during ERCP procedure. The real-time effective doses were displayed at a monitoring screen. A dosimeter was attached outside thyroid collar of each ERCP team member included of 1st endoscopist, 2nd endoscopist, and nurse anesthetist.

Patients' age, gender, BMI, body thickness, and indications for ERCP were recorded. The patients were randomized into 2 groups by block-of-four. The patients' position was assigned to prone or left lateral decubitus. Each ERCP personnel wore a lead apron and the dosimeter was attached outside the thyroid collar. The ERCP procedure was performed according to the indication in a standard technique. After ERCP procedure, the total fluoroscopic time (minute), fluoroscopy tube voltage (kV), fluoroscopy tube current (mA), patient entrance skin dose (mGy) and personnel effective dose (Sv) from each dosimeter were recorded.

Continuous variables were compared by Student's t-test or Man Whitney U-test, where appropriate. Categorical variables were compared by Chi-square or the Fisher exact test. Statistical analysis was calculated by using SPSS statistical software (version17 for Window, Chicago, USA) and two sided p-value \< 0.05 was considered to be statistical significant.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for ERCP

Exclusion Criteria:

* pregnancy
* American Society of Anesthesiologists (ASA) physical status class III - IV
* unstable vital signs
* patients' position needed to be changed during the procedure
* patients who need fixed position for ERCP (such as biliary hilar lesion)
* enteroscope-assisted ERCP
* the consent form can not be obtained
An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

The primary aim was to examine the feasibility of recruiting and retaining participants for an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone, to evaluate the acceptability of the intervention, and to assess the appropriateness of the outcome measures. The secondary aim was to evaluate the preliminary intervention effect on fatigue impact, activity performance, and participation in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months post-cardiac arrest
* Presence of moderate-to-severe fatigue: ≥ 4 score on the Fatigue Severity Scale
* Availability of landline telephone or cell phone
* Living within 150 miles of the University of Pittsburgh, Oakland
* Functional English fluency and literacy
* Intact cognition
* Community living
Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine

Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.

Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.

Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment

Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.

Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 carriers
* Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
* HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
* Patient 18 years of age or older
* Patient able to read, understand and answer self-questionnaires in French

Exclusion Criteria:

* Pregnant or breast-feeding women
* Known hypersensitivity to cabotegravir or rilpivirine
* Documented resistance to cabotegravir or rilpivirine
* Chronically active hepatitis B (HBsAg+)
* Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.