cyrilzakka/clinical-trials huggingface dataset:
Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD

This study aims to establish the treatment scheme of Bufei Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline and forming high quality evidence.

COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. More than 70% of patients with COPD are in GOLD stage 1 (mild) or 2 (moderate), with very mild or no apparent respiratory symptoms such as dyspnea. The Tiotropium in Early Chronic Obstructive Pulmonary Disease Patients in China (Tie-COPD) trial was designed to investigate the effect of tiotropium on the FEV1 in COPD patients with GOLD stage 1 or 2. The investigator's previous studies also suggested that traditional Chinese medicine (TCM) has effect on GOLD stage 1 or 2 COPD.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Bufei Jianpi granule for delaying pulmonary function decline in early-stage (GOLD stage 1 or 2) COPD subjects. After a 14-day run-in period, 612 subjects will be randomly assigned to treatment group or control group for 104-week treatment. The primary outcomes include pulmonary function and frequency of acute exacerbation. The secondary outcomes include clinical symptoms, dyspnea, exercise capacity, quality of life and treatment satisfaction. Safety will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of early-stage (GOLD stage 1 or 2) COPD.
* Syndrome differentiation meets criteria of Qi deficiency of the lung syndrome, Qi deficiency of the lung and spleen syndrome or Qi deficiency of the lung and kidney syndrome.
* Age ranges from 40 years to 80 years.
* With informed consent signed.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with severe cardiovascular and cerebrovascular diseases.
* Patients with severe liver and kidney diseases.
* Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases.
* Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
* Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
* Patients with severe cognitive and psychiatric disorders.
* Patients with diabetes.
* People who are allergic to the treatment drugs.
* Patients who have participated in other clinical studies in the past 4 weeks.
* Patients who have experienced one or more acute exacerbation in the past 4 weeks.
Exploration of Standard Surgical Indication in Gallbladder Benign Disease

This study evaluates life quality of patients who were diagnosed with gallbladder benign disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will establish a database including 20,000 patients. Through observational followup and statistic analysis，identifing a model or scale to standardized surgical indication, help surgeons and patients determine the best treatment decision.

The incidence of gallbladder benign diseases are increasing today. Most patients are accepting cholecystectomy. Is it better postoperation for this sort of patients? In other words, there is no specific indication for cholecystectomy in gallbladder benign diseases. Investigators want to explore the specific surgical indication for these patients so that surgeons could help patients make the best decision according to our evaluation model. This model may be a scale that summarizes and quantizes correlative factors of individual, which will be discussed by statisticians and experts of biliary surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from December 2016 to September 2018.
* Have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent.

Exclusion Criteria:

* Complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer.
* Complicated with severe diseases such as organ dysfunction that cannot accept surgery
* Abdominal operation history.
* Pregnant or lactation.
* Coagulopathy.
Transfusions and Nitric Oxide Level in Preterm Infants

The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants. The long term goal of the project is to identify variation in the SNO-Hb between packed red blood cell units, and between and among individual preterm infants pre and post-transfusion. Duke investigators are developing methods to replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical trial testing treated vs. untreated RBC transfusions in extremely premature infants.

AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb \[Fe\] NO, SNO-Hb (a calculated value = (total Hb-NO - Hb \[Fe\] NO) in blood to be transfused in extremely preterm babies, and in samples pre and post- transfusion from the babies.

Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm infants and will be decreased in the post-transfusion samples from the infants compared with the pre-transfusion samples.

AIM 2. Collect clinical data about study participants, including oxygen saturation and measures of perfusion pre and post-transfusion.

Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Infant \< 28 weeks gestation at birth
* Undergoing PRBC transfusion with a volume ≥ 10 cc/kg
* Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

* Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
* Previous participation in the study.
Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention

In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is consumed as a traditional remedy for several ailments, including the use as a nutritional supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue. While the elderly use it as a nutritional supplement, students use it for relief from anxiety during exam times.

The present study is conducted in order to assess the effects of BEC on various physical and mental parameters including physical fatigue, working memory and attention, mood and stress, in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Normal BMI
* Not continuously taken Essence of Chicken for the last 3 months
* Physical and psychological fatigue inclusion criteria/test/cutoff using CFQ (where individuals' CFQ scores 4 or above)

Exclusion Criteria:

* Suffering from chronic or malignant diseases e.g. cancer, heart, liver, renal or other metabolic diseases.
* Any psychiatric or neurological disease
* Pregnant and lactating women
* Subjects participated in any investigational drug trial within 4 weeks before screening
* Consumption of food supplement in the previous 2 weeks
* Professional athletes
* Subjects with recent lifestyle changes in the past 4 weeks
* History of allergy to chicken meat and seafood
The Effect of Parental Presence on Dental Fear

150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse rate for each patient was measured at different clinical situation starting from patient parent separation until end of appointment using a pulse oximeter, Data which collected was statistically analyzed using appropriate statistical analyses using SPSS ver.19 data processing software.

150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Only children who were classified as anxious but able to cope were included in the study (Rating 2 on the Venham's scale).

Pulse rate for each patient was measured at six different clinical situations. 1) Baseline 2) Seating of the child at the chair, 3) Arrival of the dentist, 4) Administration of local anesthesia 5) During the procedure, 6) End of Appointment.

Based on the accompanying person the children were classified as children accompanied by mothers alone, children accompanied by fathers alone, children accompanied by both parents.

The behavior of the child at each situation was recorded using the modified Venham's scale at each interval. The heart rate and oxygen saturation were recorded using pulse oxymetry

Eligibility Criteria:
Inclusion Criteria:

* No previous restorative dental experience
* At least one maxillary posterior tooth requiring restorative care
* Parental consent to participate in the study

Exclusion Criteria:

* Children with previous restorative dental experience
* Children with intellectual disability
* Children with diagnosed neurobehavioral disorders, including (but not limited to ), Autism spectrum disorders, learning disabilities, cerebral palsy, attention deficit hyperactivity disorder
Dry Needling vs Injection in Patients With Temporomandibular Disorders

The main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 60 years.
2. Pain of more than 6 weeks of evolution in the craniofacial region.
3. TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.

Exclusion Criteria:

1. Previous injection or dry needling intervention (3 months) on the masseter muscle.
2. Arthrogenous TMD.
3. History of trauma, infection in the temporomandibular joint in the last 6 months.
4. Coagulation disorders.
5. Pregnancy.
Oral Nitrite Synthesis and Post-exercise Hypotension

Exercise is probably the most effective approach to reduce blood pressure. In fact, a single bout of exercise induces a physiological response known as Post-Exercise Hypotension (PEH) where a prolonged decrease in resting blood pressure occurs in the minutes and hours after exercise. However, it is not fully understood how this response triggers. Recent evidence suggests that oral bacteria may play a key role in blood pressure control by enhancing nitrite, and then nitric oxide (NO) bioavailability under resting conditions in humans. However, no previous study has investigated whether this is a key mechanism involve in PEH. Thus, the main aim of this study was to investigate if the oral nitrate/nitrite pathway is a key regulator of PEH and vasodilation in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

Blood pressure (SBP \< 130 mmHg; DBP \< 90 mmHg) BMI \< 30 kg/m2 Age 18 to 50 years old

Exclusion Criteria:

Smoker Hypertension Dyslipidaemia Diabetes Gingivitis or periodontitis Using antibacterial mouthwash or tongue scrapes Taking antibiotics 1 month before the start of the study Females without have irregular menstrual periods
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time

Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, of legal age of consent
* Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
* Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following

  * meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins
  * meibomian gland orifice inclusion (plugging) or abnormal of secretion
* Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
* Ability to follow study instruction and likely to complete all required visits

Exclusion Criteria:

* Age \< 18 years old
* Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
* Patients used cyclosporine within past 1 year
* Patients used oral cyclosporine or anticholinergic drug within past 2 months
* Patients with HIV or autoimmune disease
* Patients with active ocular infections and patients with a history of herpes keratitis
* Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
* Female patients are pregnant or nursing
* Patients who wear contact lenses
BH4 Blood Levels Variations in Pre Eclamptic Women

tetrahydrobiopterin (BH4) is degraded by several enzymes, including BH4 oxidase and peroxidases. Several factors can affect its synthesis and degradation. BH4 deficiency or depletion and genetic variations in the genes involved in BH4 metabolism have been associated with hypertension, suggesting that BH4 may play a role in the pathogenesis of hypertension.

The maternity center of Tunis ( CMNT ) is a level 3 maternity center, supporting over 12 000 births yearly, where the caesarean section's rate is very high, close to 45% of deliveries.

Early detection of these patients can help control maternal and neonatal safety outcomes. we can avoid complications such as severe preeclampsia, HELLP syndrom and eclampsia for the mother, and preterm delievery and fetal growth restriction for the new born.

in the literature, studies have reported a decrease in BH4 levels in pregnant women compared to non-pregnant women and others showed that its deficiency or depletion has been associated with hypertension. Moreover, tetrahydrobiopterin administration has been studied as a potential treatment for preeclampsia but the optimal dose has not yet been determined, and further studies are needed to determine the appropriate dose, timing, and duration of BH4 supplementation in this context.

Thus, BH4 blood levels as a mean of screening, could enrich our diagnostic arsenal. The purpose of our study is to compare BH4 levels between preeclamptic and normotensive women.

The investigators will conduct a monocentric , prospective, observational study, including 300 pregnant women (150 normotensive and 150 preeclamptic).

The participants will be divided into 2 equal groups :

* Group P : Preclampsia
* Group N : Normotensive

After written and informed consent are obtained, a standard battery of blood tests including serum BH4 will be runned for the eligible patients at any moment from the admission to the end of the pregnancy.

Baseline data will be collected at enrollment, including demographic and medical history information, blood pressure, proteinuria, and blood samples for BH4 and other biomarker measurements. Follow-up data will be collected at delivery, including blood pressure, proteinuria, and fetal growth measurements, as well as maternal and neonatal outcomes;

After collecting all groups, blood samples will be analysed for BH4.

Eligibility Criteria:
Inclusion Criteria:

* Women aged over 18 YEARS
* informed consent
* Pregnant
* Term of pregnancy over than 24 weeks of gestation
* Having a normal pregnancy ( for the control group)
* Being diagnosed with preeclampsia or severe preeclampsia as defined in international guidelines (for the case group)

Non- inclusion Criteria:

* Women with known phenylketonuria
* Any history of ( treated or not) hypertension prior to the current pregnancy
* Any history of ( treated or not) diabetes or gestational diabetes during the current pregnancy
* Any history of renal failure or kidney injury) in the current pregnancy
* Women under long-term medications for arterial hypertension or before 24 week of the current pregnancy
Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging

Background:

Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.

Objective:

To explore people s values, smoking attitudes, and smoking behavior.

Eligibility:

People ages 18 and older who smoke

Design:

The study takes place entirely on a mobile device.

Participants will give their age, gender, data about their smoking habits, and desired quit date.

Then they will get different texts about quitting.

Participants will answer follow-up surveys 1 and 3 months later.

...

Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.

Eligibility Criteria:
* INCLUSION/EXCLUSION:
* Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
* Subjects are eligible if they are 18+ years of age.
The Effects of Breathing Exercises and Postural Exercises in Young Adults With Asthma.

The aim of this study was to investigate the effects of breathing exercises and postural exercises via telerehabilitation on respiratory parameters, posture, and quality of life in young adults with asthma.

12 young adult (18-25 years old) individuals diagnosed with asthma participated in our study (all female). All of the participants are University students.

Participants included in the study were evaluated with Asthma Control Test, Mini Asthma Quality of Life Questionnaire, International Physical Activity Questionnaire (short form) via Google Forms; Sit to Stand Test, Respiratory Rate per Minute and Oxygen Saturation were assessed at Yeditepe University Physiotherapy and Rehabilitation Laboratory both at baseline and at the end of the 5th week. Breathing and postural exercises were given to the participants for the duration of 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in research.
* Patients in young adults (18-26 years old)
* Stable asthma.
* Modified Medical Counsel Research Dyspnea Test (mMRC) is 2 and above
* To stay consistent with an exercise program.

Exclusion Criteria:

* Being younger than 18 years old.
* Patients with severe asthma.
* Modified Medical Counsel Research Dyspnea Test (mMRC) is below 2
Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants, including vigorous infants in the delivery room, has been featured as a standard of newborn care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the recommendation for routine suctioning of infants following delivery, provided they are not depressed or in need of immediate resuscitation. However, this new alternative recommendation was based on a small randomized trial and other lower level evidence rather than evidence from larger trials. The NRP Textbook cautions against vigorous suctioning because of the resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e. simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side effect profile compared to suctioning.


Eligibility Criteria:
Inclusion Criteria:

* Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.

Exclusion Criteria:

* Major birth anomalies or where a decision to institute comfort care only has been made antenatally
* Significant resuscitation efforts are anticipated prior to delivery
* Nonvigorous infants with meconium stained amniotic fluid
Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo

This is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on GIST on the Region of Coquimbo from 2003 to 2008.


Eligibility Criteria:
Inclusion Criteria:

* All operated patients with GIST
* Positive immunohistochemistry

Exclusion Criteria:

* Patients with GIST not operated
* Patients with GIST operated on but without immunohistochemistry