cyrilzakka/clinical-trials huggingface dataset:
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

The proposed research will provide significant new gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to explain the differences in the prevalence of smoking in men and women, sex-specific differences in nicotine craving and withdrawal as well as the poorer therapeutic response to NRT. This work may pave the way to the design of improved pharmacotherapies that can more effectively target the endogenous opioid system in the treatment of nicotine dependence.

While smoking prevalence has declined for both men and women over the last two decades, rates among women have shown a much shallower decrease and, in recent years, prevalence of cigarette initiation has been higher for girls than boys. Smoking among women of child-bearing age has significant negative health consequences for mother and child, increasing fetal and infant morbidity and mortality. Women are both less likely to initiate a quit attempt and more likely to relapse if these women do quit. Nicotine replacement therapy (NRT), still the most widely used smoking treatment intervention in the United States, is less effective for women compared with men, and women report less craving reduction on NRT. The endogenous opioid system is involved in smoking initiation, nicotine craving and reward as well as nicotine withdrawal symptoms. Interestingly, research suggests that sexual dimorphic features of the endogenous mu-opioid system may in part explain gender differences in nicotine effects. To better understand the role of the mu-opioid system in poorer NRT responses in women, this proposal will examine NRT effects on mu opioid receptor binding potential (MOR BP) in female compared to male smokers during active versus placebo NRT. Specifically, nicotine dependent women and men in active smoking status will undergo PET imaging for MOR BP measurement using 11C-carfentanil. Following baseline PET measurement in active smoking (scan 1), smokers will be randomized to active or placebo nicotine replacement therapy ((A-NRT or P-NRT); 72 hours later, a second scan will be obtained. As a reference group, demographically-matched women and men who have never smoked will undergo two scans as well. Behavioral measurements of nicotine reward, craving and withdrawal will be obtained repeatedly across the protocol. The proposed research will provide significant new, gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* 21 - 60 years old
* must meet DSM-IV criteria for nicotine dependence and be actively smoking

Exclusion Criteria: subjects must meet study guidelines for medical and mental health status.
Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

Asthma is a long-term disease process with genetic, allergic, environmental, infectious, emotional and dietary influences. The symptoms control are mainly using an inhaled drug, avoiding triggers or taking preventive medicine. Although side effects are unlikely at low dose of the asthma treatment, they have become apparent at the higher dose. Due to safety concern, parents often turn to complementary and alternative medicine which they believe is natural and safe and may help to reduce the conventional medication dosage.

There are number of reports that treatment with traditional Chinese herbs or formulas resulted in significant improvement in lung function and reduction in the airway hyper-reactivity reaction. Our study drug CUF2, was based on a classical formulae and had been proven to have anti-inflammatory and immunomodulatory activities in laboratory and animal studies.

With the pre-clinical evidence, this study aims to determine the effect of CUF2 on improving the clinical symptoms, biochemical markers, and requirement of steroid dosage among children with asthma.

Patients are recruited from 2 major governmental hospitals in Hong Kong (Prince of Wales Hospital and Tuen Mun Hospital),aged between 7 to 15 years with mild to moderate asthma according to the Global Initiative for Asthma guideline, on regular inhaled steroid therapy and capable to perform a lung function test.

However, those patients are excluded if they could not swallow capsules or had received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in the past 4 weeks.

Before study start, written informed consent will be obtained from each patient and one of their parents. The eligible patients will be randomly assigned to receive CUF2 or placebo capsules for 6 months. For the dosage, children aged above 12 years old, 3 capsules twice daily and under 12 years old, 2 capsules twice daily.

During the 6 months period, below measurements will be taken:

* The severity of asthma symptoms was assessed using a modified Disease Severity Score (DSS)
* Lung Function Test by spirometry (SpiroPro Jaeger Toennies, Hoechberg, Germany)
* Conventional Medication consumption, according to GINA/NIH guidelines.
* Blood test, EDTA and clotted blood samples were taken at the baseline and end of the study for eosinophil counts, IgE level and cytokine assay.

Eligibility Criteria:
Inclusion Criteria:

* Persistent Mild to Moderate Asthma
* Aged 7 to 15 years
* On Regular inhaled steroid therapy
* Able to perform reproducible spirometry

Exclusion Criteria:

* Could not swallow capsules
* Received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in past 4 weeks
A Study of Diarrhea and Intestinal Flora Changes Caused by Pyrotinib in Breast Cancer

By measuring the intestinal flora abundance and bacterial count of patients in the early stage of using pyrotinib to clarify the relationship between diarrhea caused by pyrotinib and changes in intestinal flora in breast cancer patients, the correlation between the change of intestinal flora and the relief of diarrhea are also explored after two-cycle treatment.

In recent years, small-molecule tyrosine kinase inhibitors (TKI) have achieved good results in anti-HER2 therapy and have been widely used in clinical practice, such as Breast cancer. However, such drugs can easily cause diarrhea and disorders of intestinal flora , may affect the efficacy of the drug and lead to the occurrence of other diseases.This study is to clarify the connection between the diarrhea caused by pyrotinib and the change of intestinal flora, pave the way for studying on whether the flora affects the efficacy of the drug and whether the flora should be supplemented appropriately in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patients aged 18-75 years.
2. ECOG performance status of 0 to 1;
3. Known hormone receptor status;
4. HER2 positive breast cancer and previously reveived ≤2 anti-HER2 therapy;
5. Breast cancer patients are about to receive pyrotinib monotherapy or combined with Trastuzumab/Inetetamab and chemotherapy；
6. Patients with adequate organ function before enrollment (no blood transfusion, no white blood cell or platelet-elevating drugs used within 2 weeks before screening): 1) Blood routine:ANC≥1.5×10\^9/L; PLT≥90×10\^9/L; Hb≥90 g/L；2)Blood biochemistry: TBIL≤1.5×ULN;ALT and AST ≤1.5×ULN; alkaline phosphatase ≤ 2.5×ULN; BUN and Cr≤1.5×ULN；3) Cardiac color Doppler ultrasound:LVEF≥55%；4) 12-lead ECG: QTcF \< 470 msec;
7. Signed the informed consent form prior to patient entry, and have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria:

1. patients with Severe heart disease or discomfor;
2. Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors ;
3. Inability to swallow, intestinal obstruction, or other factors that affect the taking and absorption of the drug;
4. Allergy to pyrotinib; history of immunodeficiency, including HIV positive, active HBV/HCV, other acquired or congenital immunodeficiency disease and organ transplantation history;
5. Patients during pregnancy or lactation, patients with childbearing potential tested positive in baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial and 7 months after the last study medication;
6. patients with intestinal disease, serious concomitant diseases, or other comorbid diseases that will interfere with the planned treatment, or patients not eligible for this study judged by the investigator.
Influence of Socket Volume on Prosthesis Performance

The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.


Eligibility Criteria:
Inclusion Criteria:

* transtibial amputee
* at least 18 months post amputation
* over 18 years of age
* capable of treadmill walking and 90 seconds of continuous standing

Exclusion Criteria:

* skin breakdown on the residual limb
Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery

All patients undergoing laparoscopic visceral and gynecologic procedures using the combined bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a prospective registry. Data will be analysed concerning the safe use of the instrument and perioperative blood loss.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing laparoscopic visceral or gynecologic surgery
* need for a vessel sealing device during surgery

Exclusion Criteria:

* non able to understand informed consent or missing consent
* age \<18
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).

The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-85 years only
* English speaking
* Severe aortic stenosis, defined as an aortic valve area \< 1 cm2
* Never had AVR or who had previous AVR \> 6 months previous
* Patients perceived by the clinician to be at low or intermediate risk for SAVR

Exclusion Criteria:

* Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention
PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer

This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced esophageal cancer. Blood or tissue samples will also be collected for research purposes.

This is a prospective clinical study of ex-vivo selected, engineered, and expanded PD-1 knockout T cells from autologous origin. 16 advanced esophageal cancer patients are planned to receive two cycles of PD-1 knockout engineered T cells infusion. Immunological markers are analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent or metastatic esophageal cancer
* Measurable disease
* Progressed after standard treatments
* ECOG performance status of 0-2
* Expected life span: \>= 3 months
* Toxicities from prior treatment has resolved or ≤ grade 1
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
* Poor vasculature
* Disease to the central nervous system
* Blood-borne infectious disease, e.g. hepatitis B
* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
* With other immune diseases, or chronic use of immunosuppressants or steroids
* Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Decision of unsuitableness by principal investigator or physician-in-charge
Local Infiltration Analgesia Following Total Knee Arthroplasty

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee arthroplasty
* Aged 20-85 yrs
* ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria:

* Known allergy or intolerance to one of the study drugs
* Serious liver-, heart- or renal decease
* Rheumatoid arthritis
* Chronic pain or bleeding disorder
Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation

The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:

* Post operative pain: incidence and intensity
* Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor
* Time needed for the instruments to reach to the full working length


Eligibility Criteria:
Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
* Age between 30-60 years old.
* Males \& Females.
* Patients' acceptance for participating in the trial through an informed consent
* Maxillary permanent premolar teeth:

  * Diagnosed clinically and radiographically with pulp necrosis
  * With or without periapical radiolucency
  * Negative response of pulp tissue to thermal and electric pulp tester
  * Possessing two independent roots each having a type I canal
  * Patent canals with no internal calcification or resorptive lesions
  * Fully formed roots
  * Root curvatures less than 30

Exclusion Criteria:

* Patient with contributory medical condition
* Badly destructed teeth
* Patients with pre-operative pain
* Patients having significant systemic disorders
* Patients with two or more adjacent teeth requiring root canal therapy
* Patients who had received antibiotics in the last month
* Teeth presenting with:

  * Positive response to thermal or electric pulp tester
  * History of trauma or previous endodontic treatment
  * Immature or open apices
  * Association with acute periapical abscess and swelling or fistulous tract
  * Fused roots at any level
  * Canals larger than size 15# K-file
  * Periodontonal/ endodontic lesions
  * Mobility higher than grade I
  * Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
  * Severe root curvature (\>30)
The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients

This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 1 diabetes
* Patients on insulin therapy
* Patients on antibiotics
* Pregnant and lactating women
* Smoking individuals
* Patients with comorbidities (except for hyperlipidemia and blood pressure)
* Patients taking immunosuppressants
* Patients taking probiotics, prebiotics or synbiotics

Exclusion Criteria:

* Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl)
* Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl
* Male and female patients aged (18-70) years
* Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl
* BMI ≥ 25
Pre-flight Evaluation of Adult Patients With Cystic Fibrosis

The purpose of the study is to investigate the relationship between hypoxemia achieved during Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis
* \> 16 years
* Sputum test negative for Burkholderia cepacia and/or methicillin resistant Staphylococcus aureus

Exclusion Criteria:

* Ongoing infection
Comparison of the User Experience of Four Nasal Aspirators in Infants

The goal of this clinical trial is to compare the caregiver's user experience, and overall impacts on an infant's cold symptoms between four nasal aspirator devices. These devices are normally used to relieve congestion in infants. when they are sick by softening and suctioning mucus from the nose.

The main questions it aims to answer are:

What is the caregiver's user experience of the NozeBot electric nasal aspirator compared to three commonly accessible nasal aspirator devices?

Are there changes in the infant's sleeping, feeding, or breathing as reported by the caregiver when using the NozeBot compared to the three other nasal aspirator devices?

Are there changes in their caregiver's habits when using the NozeBot compared to the three other nasal aspirator devices?

Researchers will compare the self-reported measures of caregiver's user experience, reported changes to their infant's symptoms, and reported changes to their own sleeping and care habits between the NozeBot electric nasal aspirator and three comparator devices: the NoseFrida SnotSucker, the hydraSense Baby Nasal Aspirator Kit, and the Braun electric nasal aspirator.

Participants will be assigned to receive one of the four devices at the start of their participation. They will be asked to use the assigned device at home according to the device instructions during two periods: (1) for 10 days while their infant is sick, and (2) for up to 3 months after.

During these periods, participants will be asked to complete online surveys at predetermined intervals to report the user experience, any changes to their infant's sleeping, feeding or breathing, and any changes to their own sleeping habits and perceived stress levels. These intervals for survey completion are: (i) after 1-2 days of use while their infant is sick, (ii) after 4-5 days of use while their infant is sick, (iii) after 7-10 days of use while their infant is sick, and then (iv) biweekly for 3 months.


Eligibility Criteria:
Inclusion Criteria

A parent(s)/caregiver(s)/family will be eligible to participate if:

* They have a child between 2 months - 18 months of age
* They are seeking outpatient care for that child for a respiratory illness (cold, flu, RSV) at the Kids Come First Care clinic
* The child does not have any contraindications to the use of a nasal aspirator
* The parent(s)/caregiver(s) are fluent in English

Exclusion Criteria

A parent(s)/caregiver(s)/family will be ineligible to participate if:

* They have a child younger than 2 months or 13 months old or older currently seeking outpatient care for a respiratory illness
* The child is admitted to hospital
* The child does not have a respiratory illness
* The child has a diagnosed craniofacial syndrome
* The child has a defined contraindication and cannot use a nasal aspirator
* The parents/caregivers are not comfortable using a nasal aspirator
* The parent/caregivers are not fluent in English
Sleeper's and Adduction Stretch to Increase Shoulder ROM

The study aimed to compare the efficacy of modified sleeper stretch and modified cross-body adduction stretch in improving shoulder internal rotation range of motion and upper limb function. Thirty male lawn tennis players aged between 20 to 35, with more than 150 glenohumeral internal rotation deficiency (GIRD) on the dominant shoulder (compared to the nondominant side) participate in the study and divided into two groups (A and B). Group A received a modified sleeper stretch and group B received a modified cross-body adduction stretch for four weeks, five times per week. The outcome measures were the internal rotation range of motion measured by a universal goniometer and upper limb functions measured by the Disability of the Arm, Shoulder, and Hand (DASH) scale.


Eligibility Criteria:
Inclusion Criteria:

* Lawn Tennis Players
* Male
* more than 15 degree glenohumeral internal rotation deficiency

Exclusion Criteria:

* systemic or metabolic disorders
* a positive test for labral lesions or rotator cuff tears
* a history of recent fracture
* a history of orthopaedic surgery in the upper limbs or cervical region