cyrilzakka/clinical-trials huggingface dataset:
The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension

This study aims to investigate the relationship among self-efficacy, anxiety, depressive symptoms, quality of life, lifestyle, heart rate variability and blood pressure control; and to examine the effects of self-titration strategy on self-efficacy, anxiety, depressive symptoms,heart rate variability, sodium excretion, lifestyle modification,quality of life, and blood pressure control in patients with hypertension.

Background: Hypertension is the major cause of mortality for the cardiac, vascular and renal disease. The effective control of elevated blood pressure may reduce the damages of several target organs. World Health Organization points out "Innovation and Empowerment for health". The self-titration strategy may empower patients to self-control their diseases, share decision-making and increase their ability to self-management their situations and improve their home blood pressure.

Methods: This experimental study included 222 hypertensive patients from outpatient services of cardiology departments of a medical center in northern Taiwan. We randomly divided the 72 patients into the experimental group (n=111) and control group (n=111). The experimental group received self-titration strategy training and lifestyle modification education; the control group received usual care and lifestyle modification education.

Data were collected for self-efficacy, anxiety symptoms, depressive symptoms, lifestyle and health-related quality of life using self-report questionnaires. Heart rate variability was measured with CheckMyHeart device (DailyCare BioMedical, Chungli, Taiwan). Patients evaluated their home blood pressure by corrected sphygmomanometer. We used the generalized estimating equation to evaluate the effects of the intervention.

Purpose: Primary outcome to evaluate the effects of self-titration strategy on the improvement of home blood pressure in patients with hypertension. Secondary outcomes to evaluate the effects of self-titration strategy on the improvement of self-efficacy, anxiety, depressive symptoms and lifestyle quality of life in patients with hypertension.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 20 years old.
2. diagnosed with primary hypertension.
3. no addiction to drugs or alcohol.
4. not using anti-depression therapy.
5. able to read and understand Chinese or Taiwanese.
6. willing to participate in this study.

Exclusion Criteria:

1. stroke.
2. arrhythmia.
3. major psychiatric disorders
4. thyroid disease.
5. had received a heart transplant, a permanent pacemaker or an implantable cardioverter defibrillator, diagnosed with (6) cancer, (7) heart failure, or (8) acute myocardial infarction.
Amr Maneuver for Prevention of Postpartum Hemorrhage

The patients were divided randomly in to 2 GROUPS:

* control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
* study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

The patients were divided randomly in to 2 GROUPS:

* control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
* study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .

Eligibility Criteria:
Inclusion Criteria:

* women who candidate for vaginal delivery at casualty department singleton fetus full term pregnancy ( gestational age of more than 37 weeks).

Exclusion Criteria:

* fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension.
The Acute Effect of a Mobilization With Movement Technique to Improve Internal Rotation of the Shoulder

For many years researchers have been documented that the shoulder of the throwing athlete acquires a increase in external rotation of the dominant limb compared to the contralateral side.This fact is followed with a loss of the internal rotation of the shoulder, which is related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal Rotation Deficit (GIRD).

Among the approaches for this condition the literature is inconclusive due to the low methodological quality of clinical trials made,however, the manual therapy has been used with success to relief the pain and restore the range of motion.

The purpose of this study is to analyse the effectiveness of a mobilization with movement technique to improve the internal rotation of the shoulder in throwing athletes with GIRD.

It will be a randomized controlled trial with the CONSORT bases with 40 participants that will be divided into two groups:

* Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.
* Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up(five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement technique to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention.

To evaluate the range of movement it will be use a standard goniometer with an attached customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to the ground.

The investigators hypothesis is that both group will have improvements in the internal rotation of the dominant shoulder, however, the mobilization group will have a statistically significant difference compared to control group immediately post-intervention. Four weeks post-intervention this difference will equalize, because of the only intervention applied.

Results will be expressed as hazard ratios (HR) with their respective confidence intervals at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0


Eligibility Criteria:
Inclusion Criteria:

* Athletes that practice at least 10 hours of throwing sports.
* Glenohumeral internal rotation deficits of the dominant shoulder compare to the non-dominant limb.
* Agree to participate and signing the informed consent approved for the Federal University of São Paulo ethics committee.

Exclusion Criteria:

* Previous surgeries of the shoulders.
* Unable to perform the evaluation or treatment due to pain.
* Performing physical therapy treatment.
EEG in Resuscitated In-hospital Patients

In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Resuscitated in-hospital patients

Exclusion Criteria:

* Patients with Do Not Attempt to Resuscitate-decision
* Patients who are not going to be treated in ICU after resuscitation
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected with HCV genotype 1
* HCV treatment-naïve
* Not co-infected with HIV or HBV
* HCV RNA viral load of at least 100,000 IU/mL
* BMI 19 to 35 kg/m2
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse
A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation

The purpose of this study is to determine if a new technology applied while listening to a mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The new technology is called transcranial direct current stimulation, or tDCS.

Many people initially attempt meditation but cannot get their mind to be still. Or they do not get quick results and find it frustrating. Thus, the number of people benefiting from meditation would increase if there were a method of making it easier to perform. Moreover, establishing the actual brain mechanisms involved in the benefits of meditation would potentially open up synergistic treatments and approaches.

The investigators will investigate the use of a new, non-invasive brain stimulation method called transcranial direct current stimulation (tDCS) to augment a state of mindfulness. tDCS is a safe, inexpensive, non-invasive brain stimulation modality that has the capability of focally increasing or decreasing cortical activity. Anodal stimulation produces positive DC stimulation and is associated with increased cortical activity, whereas Cathodal stimulation produces a negative DC stimulation and is associated with decreased cortical activity. Cortical activity changes occur both during and after stimulation in a dose response fashion (higher current density and longer duration of stimulation produces larger and longer lasting effects).

The investigators will be investigating the use of tDCS to augment mindfulness meditation in a double-blind, crossover, randomized, sham-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control volunteers.
* meditation naive

Exclusion Criteria:

* Pregnancy,
* History of Mental illness or neurological disorders,
* prior meditative experiences
An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

This observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy.

This study protocol is for the second part of SpaceOAR real world study in which long term follow-up visits will be performed (up to 1 year) outside Boao Medical Tourism Pilot Zone. The SpaceOAR real world study is a retrospective and prospective, single arm, observational study (Ptotocol of SpaceOAR RWS Windchill#: 92743236). Subjects with localized T1-T2 prostate cancer who have already been injected with the SpaceOAR and have received radiotherapy or will receive radiotherapy will be enrolled, and clinical data related to radiotherapy will be collected. For subjects who have already completed radiotherapy before study kick-off, clinical data will be collected retrospectively, such as data related to radiotherapy, AE (if any) and MRI (if any). Follow up vist will be completed if applicable. For subjects who receive therapy after study kick-off, follow up visits at 2 weeks, 6weeks, 3 months and 10 months after radiotherapy will be scheduled to assess bowel, urinary and sexual function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have provided the written informed consent, are willing to participate in clinical data collection and willing to comply with study procedure. (for subjects enrolled prospectively)
* Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated with Space OAR Hydrogel, and have received or will receive radiotherapy.

Exclusion Criteria:

* All subjects have received radiotherapy or will receive radiotherapy, who have injected with SpaceOAR hydrogel in Boao Medical Pilot Zone.
* There is no specific exclusion criteria unless the patients refuse to sign the informed consent.
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants

The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.

This prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. Preterm infants with a gestational age (GA) ranging from 30 to 35 weeks and whose mother chose formula feeding were enrolled during their first three days of life. Both parents provided informed written consent. Infants were randomly assigned to receive either the fermented preterm formula (FPF) or, as a control, a formula adapted for preterm infants (PF). The PF was formulated to meet the nutritional needs of preterm infants. The FPF was identical, except for a manufacturing process including a fermentation step with two probiotic strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, inactivated by heat at the end of the manufacturing process. This process conferred a probiotic/prebiotic activity.For each neonate, background information about the pregnancy and neonatal parameters were collected. Anthropometric parameters (weight, height, head circumference); gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal bleeding, NEC); drug administration; and intake of formula and mother's milk were recorded twice a week until discharge. Stools were collected twice a week from diapers for microbiological analysis and measurement of fecal inflammatory markers. All samples were immediately stored at -80°C.

Eligibility Criteria:
Inclusion Criteria:

* Preterms with gestational age ranging from 30 to 35 weeks
* Eutrophic
* Formula feeding

Exclusion Criteria:

* Malformation or metabolic disease
* Newborns whose parents did not provide informed consent
* Contraindication to enteral feeding
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities

The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value \<90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.

The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.

Exclusion Criteria:

* Caesarean section urgent / emergent
* Caesarean section with epidural anaesthesia
* Caesarean section of multiple pregnancies
* Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (\<32 weeks)
* Valvular heart disease and / or ischemic
* High blood pressure diagnosed and in treatment.
* Sepsis
* Morbid obesity (BMI\> 40)
* Insulin-dependent diabetes
* Block level achieved with spinal anaesthesia\> T5
* Patients that can not meet the study protocol
Local GIT Hormones After Bariatric Maneuvers

Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides.

Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients.

Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients. Age ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist, Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done after two weeks and after 2 months.

Eligibility Criteria:
Inclusion Criteria:

All morbid obese patients

-

Exclusion Criteria:

GIT diseases
DDN in Stroke--COBRE

The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain.

The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* no known neurological injuries.
* neurologically stable for \>6 months (and \>1 yr post stroke)
* medical clearance to participate
* unilateral ankle and/or wrist spasticity, confirmed by Modified Ashworth Scale (MAS) \> 1 and the presence of spastic hyperreflexia

Exclusion Criteria:

* motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation
* a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension)
* a medically unstable condition (including temporary infections and pregnancy)
* age \<18 years old
* cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol
* metal allergies
* needle phobias
* lymphedema over a limb (due to risk of infection/cellulitis)
* abnormal bleeding tendencies
* compromised immune system
* vascular disease
* uncontrolled diabetes
* history of epilepsy (as DDN generates strong somatosensory sensation)
* anxiety disorders or in distress
* botox injection in target muscle within 3 months prior to start of study
1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment

A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.

This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.

Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
* requiring treatment either with metformin alone or combined with insulin

Exclusion Criteria:

* type 1 and 2 diabetes
* bad obstetrics history
* underlying medical disorders such as Systemic Lupus Erythematosus
* fetal anomaly
* delivery elsewhere