cyrilzakka/clinical-trials huggingface dataset:
The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil

To explore the epigenetic mechanism of postoperative analgesia and side effect induced by μ-opioid Receptor Agonists presented with sufentanil among general population.

Patients were interviewed the day before surgery, and taught about the use of PCA pump and VAS. Pressure pain threshold(PPT) and pressure pain tolerance(PTO) were collected before surgery.

Dexmedetomidine1μg/Kg，sufentanil 0.5μg/Kg， propofol 2mg/Kg and rocuronium 0.6mg/Kg were given intravenously for induction. Anesthesia was maintained with inhalation of 1% sevoflurane and infusion of remifentanil (0.2-0.4ug/kg/min) and propofol (6-10mg/kg/h). Aterial blood pressure(ABP)，central venous pressure(CVP)，SPO2， HR，ETCO2，T and Narcotrend were monitored. Before incision, parecoxib 40mg was given intravenously, and PCA with sufentanil 1ug/ml was started immediately after surgery, suing a controlled infusion pump. The pump was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml with 1 h period.

VAS(static), VAS(dynamic), Ramssay, HR, NBP, SpO2, PCA pressing frequency, PCA comsumption were recorded 6h, 12h, 24h, 48h after surgery. Side effects such as nausea, vomiting, respiratory depression; pruritus; abdominal distention; urinary retention and dizziness were also recorded, and corresponding treatment were given.

EDTA anti-coagulated blood was collected from a central venous catheter during the operation. Genomic DNA was extracted from the blood samples, and characteristics and degree of DNA methylation of the gene OPRM1 were analysed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status Ⅰ-Ⅱ ;
* Weight 50-75 kg;

Exclusion Criteria:

* Long history of alcohol or analgesic drugs(including opioid ) abuse;
* Heavy smoking;
* Motion sickness;
* Long history of PONV;
* Chronic pain;
* Complicated with severe heart、brain or kidney disease.
Effect of a Combined Use of Mosquito Repellent and Insecticide Treated Net on Malaria in Ethiopia

The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by household members would result in a 40% reduction in malaria prevalence compared with households that only use LLINs.

It has been recognized that the use of malaria preventive measures in combination with LLINs could improve the effectiveness of nets in preventing the disease. This study examined the effect of a combined use of mosquito repellent (i.e., Buzz Off) and LLINs on malaria prevalence in an area of unstable and seasonal malaria transmission.

Eligibility Criteria:
Inclusion Criteria:

* All volunteer household members

Exclusion Criteria:

* Infants less than two months
* Not in the study area
Supporting Healthy Relationships Program for FRAMEWorks (SHR FRAMEWorks)

The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?

More specifically, the investigator is interested in answering the following research questions:

Primary Study Question:

1. To what extent do clients show increased relationship satisfaction (Primary Endpoint: Couples Satisfaction Index-CSI) after receiving the virtual Zoom relationship education intervention? a) To what extent do partner effects impact this outcome?

   Secondary Study Questions:
2. To what extent do clients learn and retain the knowledge and skills that are taught in the relationship education intervention? a) To what extent do partner effects impact this outcome?
3. To what extent do clients become more emotionally intelligent after the relationship education intervention? a) To what extent do partner effects impact this outcome?
4. To what extent do clients show improved co-parenting relationships after the relationship education intervention? a) To what extent do partner effects impact this outcome?
5. To what extent do clients become more securely attached to their partners after receiving the relationship education intervention?

   a) To what extent do partner effects impact this outcome?
6. To what extent do clients attend workshops when they are delivered virtually via Zoom?

   a) To what extent do partner effects impact this outcome?
7. To what extent are clients engaged in workshops when they are delivered virtually via Zoom? a) To what extent do partner effects impact this outcome?

Eligibility Criteria:
Inclusion Criteria:

* Married or unmarried couples who are 18 years or older
* Must have custodial children (biological, foster, adopted) under the age of 18 (or expectant parents)
* Income below 200% of poverty level

Exclusion Criteria:

* Active intimate partner violence and increased risk of intimate partner violence
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations

This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.

The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.

The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

The addition of Axitinib to existing treatment protocols and to fractionated irradiation without functional normalization of the tumor vasculature can significantly improve response to therapy, contributing to the breakdown of the metabolic symbiosis of adaptive drug resistance.

Eligibility Criteria:
Inclusion Criteria:

* histologically and immunohistochemically confirmed status of the tumor process
* мale or female, age ≥ 18 years
* Karnofsky performance status ≥ 60
* signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

* Grade 3 bleeding NCI CTCAE prior to study enrollment
* cardiac arrhythmias ≥2 according to NCI CTCAE with a corrected QT interval (QTcF) on the screening ECG \>480 ms.
* pregnancy or breastfeeding. All female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must consent to the use of effective contraception during therapy.
* severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study
* congestive heart failure (CHF) class III or higher according to the New York Heart Association (NYHA)
* subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)
Microbial Markers for AGI

AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology.


Eligibility Criteria:
Inclusion Criteria: All those critically ill patients with anticipated ICU stay for more than 2 days Exclusion Criteria:Patients will be excluded if they have any of the following situations: patients who have not signed the informed consent; Unable to tolerate intra-abdominal pressure monitoring; pregnant woman; Patients after bladder surgery; Systemic diseases and recent use of related drugs; He had a history of infectious diseases, such as tuberculosis or PPD positive. History of hypertension and poor blood pressure control (SBP / DBP \> = 140mmHg); Patients with severe mental illness; Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission.

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hBET for Pain and Sleep Feasibility

Long-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term pain is also very costly to the National Health Service. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects for some patients.

The investigators have been developing an alternative approach for treating long-term pain. This approach uses simple non-invasive tools to promote some kinds of brain activity over others. It involves patients using headphones to listen to some specific sounds, or a headset with lights flashing at particular frequencies. The studies undertaken so far seem to show that doing this can change how the brain responds to pain. It potentially offers an inexpensive yet effective way of reducing pain and improving sleep for patients with long-term pain. There are a few small studies that support this approach and more work is needed. The next step is to find out whether these tools can be reliably used in home settings, how people feel about using this approach, and to gather information to design a larger trial of this technology.

Therefore the aim of this study is to test the suitability and acceptability of these home-based tools with individuals with long-term pain. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed time every day for 4 weeks. The investigators will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how the approach should be developed. The investigators will measure changes in the nature of participants' pain, sleep, fatigue and mood.

These findings will inform the planning and design of a future much larger study to test this technology. The investigators will make sure that findings from this study are shared widely within the National Health Service and beyond among patient groups, professionals, charities, specialist centres and commissioners.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-cancer pain (recurring pain ≥ 3 months duration)
* Having nocturnal pain (NRS 0-10 worst pain ≥ 4)
* Self-reported sleep difﬁculties (trouble falling asleep, difﬁculty staying asleep, waking up too early, or waking up unrefreshed) 3 or more nights per week during the past month

Exclusion Criteria:

* Planned intervention (injection/ surgery/ new oral medications for pain or sleep) during the 4-week hBET use period
* Seizure disorder
* Photosensitivity
* Hearing or sight problems causing inability to use hBET
* Cognitive problems or dementia or mental health disorders causing inability to consent
Survey of Predictors of Human Papillomavirus (HPV) Vaccination Among Parents of Rural Adolescent Girls in Mysore, India

To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India.

Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of HPV vaccination among parents of rural adolescent girls in Mysore, India.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* parent of an adolescent girl (10 -15 years of age)
* able to speak English or Kannada
* willing to undergo informed consent process

Exclusion Criteria:

* Does not have the capacity to undergo informed consent process
The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population

The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of subjects according to a population survey in Hong Kong. Most of these patients did not show evidence of erosive change during upper endoscopy. However, patients with NERD suffer from similar impairment of quality of life as patients with erosive oesophagitis and their symptoms are as severe as patients with erosive disease. Data on the use of proton pump inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump inhibitor for the treatment of NERD in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients with age between 18 -80 years old,
* Patients with predominant symptoms of heartburn or acid regurgitation at least once weekly with no evidence of endoscopic pathology.

Exclusion Criteria:

* Patients under 18 or over 80 years of age,
* Symptoms of gastrointestinal bleeding,
* Patients who had previous upper gastrointestinal surgery,
* Patients with concomitant serious medical diseases,
* Patients who had received H2-receptor antagonists or proton pump inhibitors in the past 4 weeks,
* Pregnant or lactating women.
Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment

This study aimed to study cost-effectiveness of EndWarts® FREEZE for wart treatment, compared to conventional liquid nitrogen cryotherapy

Cutaneous warts, caused by Human papilloma virus (HPV), are common skin disease. The prevalence reported in primary school children are 2-20%, and even higher in adults. Non-intact skin are prone to the infection, with all parts of the body can be affected. Even warts are not malignant, they can cause lack of confidence or affected patients' quality of life.

Nowadays there are many treatment methods for warts, such as topical application with salicylic acid and electrical cauterization. Cryotherapy with liquid nitrogen has been the therapy of choice due to its clinical effectiveness, which reported for 6-65%. Treatment mechanism in cryotherapy relies on in-depth freezing of infected keratocyte.

EndWarts® FREEZE is alternative home treatment cryotherapy device containing nitrous oxide. Recent clinical study found that it delivers significant result with good tolerability, and is user friendly. As for our knowledge, no study has been reported about cost-effectiveness of this device, so this study was designed to demonstrate the efficacy of this product in cutaneous warts.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital

Exclusion Criteria:

* Patient with more than 5 warts or wart more than 1 cm in diameter
* Wart at face, genitalia, scalp, joint
* Pregnancy or breastfeeding patient
* Wart with wound/irritation or local infection
* Diabetes mellitus patients or patients with coagulopathies or cryoglobulinemia
* Immunocompromised host or on immunosuppressive drug
* Received any treatment in previous 3 months before inclusion
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome

The chronic use of opiate medications during pregnancy is a major public health challenge. Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability, high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and unstable body temperature. Many infants may be treated by supportive (non-pharmacological) therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other comfort care. However, some infants continue to show severe symptoms of withdrawal despite these interventions. In these cases, infants may be treated with medications (pharmacological therapy). Although it has been several decades since the first descriptions of NAS, there still remains limited information with regards to the most effective treatment. We hypothesize that medical treatment protocols of NAS with methadone can be optimized by better understanding what the body does to the drug (the population-based pharmacokinetics of methadone).


Eligibility Criteria:
Inclusion Criteria:

1. Chronic in utero exposure to opiates
2. Term infant, greater than or equal to 37 weeks gestation
3. Failure of non-pharmacologic treatment of NAS
4. Infant meets criteria for pharmacologic treatment of NAS as determined by physical findings consistent with drug withdrawal and Finnegan scoring system
5. The attending neonatologist chooses to treat the qualifying infant with oral methadone.

Exclusion Criteria:

1. Prematurity
2. Congenital Abnormalities
3. Acutely ill neonates
4. Confounding medical illness necessitating therapy with opiates other than for NAS
5. Neonates whose only exposure to opiates were narcotics administered during labor
6. Infants who are wards of the state
Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure

Alcohol use disorder (AUD) is a burdensome clinical disorder with high relapse rates. Virtual Reality (VR)-based therapeutic and diagnostic approaches have received increasing attention in the treatment of AUD but evidence on the induction of craving via VR scenarios is still needed. Craving for alcohol is associated with psychological and physiological responses. This single-arm clinical study will be conducted including n=60 patients with AUD. Using a head-mounted display (HMD), patients will be confronted with three different VR scenarios (neutral vs. two target situations) while heart rate, heart rate variability (HRV), pupillometry and electrodermal activity (EDA) will be measured continuously. Subjective craving levels will be assessed pre-/during/post-exposure to each VR scenario.


Eligibility Criteria:
Inclusion Criteria:

* age: 18-65 years
* diagnosis of alcohol dependence according to ICD-10 (F10.2)
* completed in-patient withdrawal treatment during the last 3 months
* history of alcohol craving, confirmed via craving questionnaires
* able to provide written informed consent

Exclusion Criteria:

* substance dependence other than alcohol and nicotine
* current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
* unable to understand the study information, consent form or principles of the study
* abstinence for less than 7 days or on-going consumption of alcohol
* severe neuropsychiatric disorder, e.g. schizophrenia spectrum disorders, bipolar affective disorder or substantial cognitive impairment
* serious illnesses influencing brain-/heart-function with influence on physiological study parameters.
* acute suicidality (or acute endangerment of others)
* concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart frequency.
Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers

This study aimes to analyze the effectiveness of a Hand Therapy protocol in the management of patients who suffer from a tear of a lumbrical muscle, regarding on the symptoms during the clinical examination, the disability in their activities of daily living and the sports-specific function.

A prospective intervention study is performed on 50 adult climbers suffering from an injury of the 4th lumbrical muscle. They wear during 3 weeks a 5th finger extension relative motion orthosis, while pain-free sport activities are permitted using a 4th and 5th fingers buddy-taping. After three weeks, patients are told to progressively remove the splint and, after six weeks, the splint is totally removed. Symptoms in the lumbrical stress test are evaluated during the 6 weeks period using dynamometry and goniometry, Finally, Quick-Disabilities of the arm shoulder and hand questionnaire is also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adult climbers suffering from an injury of the 4th lumbrical muscle

Exclusion Criteria:

* Patients with previous treatments.
* Patients with concomitant injuries or illness
Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients

Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.

Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.

Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point wall be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
* Women of child-bearing age: negative pregnancy test
* Ability to understand and sign a written consent form

Exclusion Criteria:

* Previous interferon treatment
* Pregnancy or breastfeeding
* Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
* Creatinine clearance \< 50 ml/min, according to Cockcroft-Gault
* Decompensated liver disease
* History of organ transplantation
* Concomitant treatment with immunomodulators or didanosine
* Alcohol abuse or use of other recreational drugs
* History of severe psychiatric conditions
* Autoimmune diseases
* Inability to understand and sign a written consent form