cyrilzakka/clinical-trials huggingface dataset:
Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia. Then, A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E).Finally, the study find that Open TPVB can provided satisfactory analgesia for patients undergoing open pulmonary lobectomy under general anesthesia, and the analgesia efficacy was equivalent to the TPVB under ultrasound guidance,which should be popularized.

Purpose: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia.

Methods: A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into 3 groups (n = 30 each) by using a random number table: PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E). In group G, patients were received PCIA after the surgery. In group U, TPVB was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml combined with the PCIA after the surgery. In group E, the TPVB was performed under the direct vision with 0.25% ropivacaine 30 ml combined with the PCIA. The Visual Analogue Score (VAS) at rest and during coughing, the sensory nerve block segment, as well as the respiratory rate were measured and recorded at different time-points. Furthermore, the hemodynamic vital signs at different time - points, the number of successfully delivered doses 48 h after the surgery, as well as the incidence of postoperative complications were also recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* with American Society of Anesthesiologists physical status Ⅰor Ⅱ
* aged 35 - 75 years old
* with body mass index of 20 - 25 kg／m2,
* scheduled for open pulmonary lobectomy under general anaesthesia at the First Affiliated Hospital of Kunming Medical University

Exclusion Criteria:

* cardiovascular and/or cerebrovascular disease;
* diabetes; pre-existing liver, lung or kidney dysfunction;
* bilateral surgery; take operations again within 48 h after the surgery;
* with serious pulmonary infection and coagulation dysfunction
Effect Of Oral And Dental Health Education In Pregnant Women

The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels.

In line with these results, it is recommended that midwives should determine the behaviors and knowledge levels of pregnant women regarding oral and dental health within the scope of primary health care services, provide trainings to increase their knowledge and awareness on the subject, refer them to treatment in the presence of problems, and expand these services within the health system.

Eligibility Criteria:
Inclusion Criteria:

* Being in the first trimester of pregnancy
* Being 19-44 years old,
* Being able to read and write turkish,
* Being a healthy pregnant woman who agrees to participate in the study

Exclusion Criteria:

* Having a risky pregnancy,
* Can't speak or understand Turkish
* Women with intellectual disability
* Serious mental disorders will be excluded from the study.
Diet and Exercise Frailty Intervention in Cardiac Device Patients

DEFINIT-P is a prospective pilot study of frailty in cardiac device recipients, comprised of a registry and randomized control trial. The RCT is a supervised exercise program and nutritional supplement intervention for pre-frail and frail cardiac device participants. The registry will be used to describe all cardiac device recipients, regardless of frailty status.

DEFINIT-P is a single center randomized controlled trial and registry.

This pilot study will determine the feasibility of a larger, multi-center randomized clinical trial which aims to evaluate the efficacy of a supervised exercise program and nutritional supplement program in reversing or preventing progression of frailty in cardiac device recipients.

The future trial would also examine the physiologic effects of exercise and nutritional supplementation to understand their effects on blood biomarker profiles, which will provide insight into potentially targetable mechanisms underlying frailty.

Eligibility Criteria:
Inclusion Criteria

1. Permanent pacemaker recipients OR
2. Implantable cardioverter defibrillator recipients

Exclusion criteria

1. Age \<55 years, or
2. Unwilling to consent

Patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of:

1. Are non-frail
2. Already undertaking \>1 hour per week of dedicated exercise
3. Existing or prior referral for cardiac rehabilitation
4. Moderate or severe heart failure (New York Heart Association class III or IV)
5. Unstable angina
6. Any other medical condition that will prevent exercise participation
7. Dementia, as identified by a Mini-Mental State Examination score \<25
Effectiveness Study of Teacher Training and Social and Financial Education in Rwanda's Primary and Secondary Schools

The study uses experimental methods to evaluate the effectiveness of an educational intervention in Rwanda. The intervention, designed by Aflatoun and AMIR, involves training teachers on the use of active-learning methods to implement a social and financial education curriculum with students in primary and secondary schools. Teachers then implement the social and financial curriculum with students in order to improve their personal, social, and financial competencies.

Teacher training will take place in November-December 2013 and the curriculum implementation will be evaluated in the 2014 school year.

The study will examine the following hypotheses:

1. Did teachers use of active learning methods in class increase due to the training received?
2. Did students' levels of engagement and on-task behaviour increase as a result of the intervention's pedagogy and content?
3. Did the following competencies of students improve due to the intervention?

   1. Self-efficacy
   2. Social skills
   3. Financial literacy
   4. Planning attitudes
   5. Savings attitudes
   6. Savings behavior
   7. Entrepreneurship
4. Did the intervention change student's pass rates on the primary six (P6) and secondary three (S3) final examinations for the classes in which it was implemented?
5. Did the intervention change student drop out rates in the classes which it was implemented?


Eligibility Criteria:
Inclusion Criteria:

* Schools willing to participate in the intervention.
* Classes of students in grade P6 or S3 during academic year 2014
* Teachers of entrepreneurship, social studies, or mathematics

Exclusion Criteria:

* Non-consenting individuals
Acetabular Shell Positioning Using Patient Specific Instruments

The proposed study is a double-blinded randomized controlled trial comparing patient specific instruments with solely standardized instruments and pre-operative planning used for the placement of the acetabular cup prosthesis used in total hip arthroplasty.

The investigators will enroll 36 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of patient specific instruments from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. Print-offs from the pre-operative plan will also be used in the treatment group.

The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

No further details to report.

Eligibility Criteria:
Inclusion Criteria:

Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:

* Primary, unilateral direct lateral or posterior THA
* 18 to 85 years old at time of surgery
* Able to get a pre- and post-operative CT scan at the Cleveland Clinic

Exclusion Criteria:

* The following criteria will exclude subjects from this protocol:
* Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
* Pregnancy
* Incarceration
* Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age.

Primary objective:

- To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest

Secondary objectives:

* To investigate ovulation inhibition
* To investigate the effect on SHBG
* To assess pregnancy rate
* To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight
* To investigate return of menstruation after treatment
* To evaluate general safety and acceptability


Eligibility Criteria:
Inclusion Criteria:

* Women willing to use a Combined Oral Contraceptive for 6 subsequent cycles
* Good physical and mental health
* Regular menstrual cycle (24-35 days) prior to screening
* Body mass index between (≥) 18 and (≤) 30 kg/m2

Exclusion Criteria:

* Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (only applicable for women who are not using a hormonal contraceptive method at the time of screening)
* Previous use of progestogen-only contraceptive methods during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception
* Use of phytoestrogens
* No spontaneous menstruation has occurred following a delivery or abortion
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
* Status post-partum or post-abortion within a period of 2 months before screening
* Pregnancy during accurate hormonal contraceptive use in the past
* Intention to become pregnant during the study
* An abnormal cervical smear within one year before study start
* Untreated Chlamydia infection
* Known or suspected breast cancer or a history of breast cancer
* A history of (within 12 months) alcohol or drug abuse
* Any clinically relevant abnormality
* Contraindications for the contraceptive steroids used in the clinical trial
* Use of antihypertensive drugs or use of medications interacting with the contraceptive steroids used in the clinical trial
* Administration of any other investigational drug within 2 months prior to screening
Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.

In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.

Eligibility Criteria:
Inclusion Criteria:

* non-eventful pregnancy
* planned elective CS
* Finnish language competency

Exclusion Criteria:

Mother:

* maternal refusal
* positive findings in screening samples
* maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord)
* travel outside European Union during 3 months prior to delivery
* CS after the onset of labor (non-elective CS)

Newborn:

* birth below 37 weeks of gestation
* Apgar score of less than 8
* disturbances of neonatal adaptation (such as transient tachypnea of the newborn)
* antibiotic treatment of the newborn before discharge
Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm

Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia, particularly the medial globus pallidus, and the clinical expression of these two diseases is characterized by a combination of motor and cognitive disorders, but with two opposing patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive origin. Far fewer studies have been conducted in Huntington's disease. However, all of these studies were performed with different methodologies in small cohorts and the value of the proposed study is to use a validated and standardized computerized mental chronometry paradigm, providing a better understanding of the mechanisms of action slowing in these two diseases and to more clearly define a disease-specific profile.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study
* French mother tongue
* MMSE \> 20/30
* Specific to the MP and MH:

  * Parkinson's disease:

    * defined by the criteria of the UKPDSBB
    * stage 1 , 2 or 3 Hoehn and Yahr (ON)
    * age of onset of the disease known
    * brain MRI performed during follow-up
  * Huntington disease :

    * genetically defined (CAG \> 35)
    * weaning neuroleptic ( Tercian® and Solian® : 2 days; Haldol® : 5 days ; Tiapridal® and Xenazine : 1 day ; Zyprexa® : 4 days)
    * Early stage : Fahn and Shoulson I and II is a CFT score between 7 and 13

Exclusion Criteria:

* Illiteracy, writing or reading difficulties
* Visual perceptual auditory deficit or preventing reading, drawing, writing or understanding instructions
* Visual hallucinations
* Significant history may sound on cognition (unbalanced thyroid dysfunction, ischemic heart disease or embolic unstabilized or symptomatic, progressive neoplasia, chronic alcoholism weaned or not)
* Current or previous neurological diseases other than MH or MP: ischemic cerebral vascular accident or bleeding, head injuries (loss of higher knowledge in 15 minutes), epilepsy requiring treatment.
* Psychiatric disorders depression unless treated (stable treatment for 1 month)
* Psychotropic treatment (except anxiolytic, antidepressant steady since 1 month)
* Inability to achieve an autonomous operation without technical assistance over a distance of 20 meters.
* Inability to stand without technical assistance for 30 seconds.
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.


Eligibility Criteria:
Patient Satisfaction and Reflection on Drain Placement

The purpose of this research study is to evaluate the ideal drain placement in patients undergoing abdominoplasty or panniculectomy. There are currently no patient reported outcome measurements on ideal drain placement and this study aims to collect objective and patient reported measures to standardize ideal drain placement.

In this study a medially and laterally placed drain will be compared to each other in each study participant. In this study subject will have two drains. One will be lateral and one medial. The drains will be secured and dressed in the same manner. At subjects planned post-operative visits, subjects will be asked to complete surveys to evaluate their experience with the drains. This study will not require additional clinic visits for study purposes.

The primary goal of this proposal is to assess patient perspectives and satisfaction with the location of their drains after abdominoplasty and/or panniculectomy. This will be conducted as a prospective observational trial, where patients with scheduled abdominoplasty and/or panniculectomy will be invited to participate. Patients will be randomized to either A) left side lateral and right side medial or B) right side lateral with left side medial. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* patient of Department of Plastic and Reconstructive Surgery
* able to sign English language Consent form
* undergoing either abdominoplasty and/or panniculectomy.

Exclusion Criteria:

* Patients with unilateral drain placement, unable to sign English language consent form
* Patient under the age of 18.
Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma

Bronchial asthma is a widespread chronic condition charactrized by inflammation and narrowing of airways, leading to repeateted episodes of breathlessness, wheezing and labored breathing.Breathing exercises help to manage hyperventilation often seen in asthmatic patients. To handle respiratory complications asthmatics are advised to practise nasal breathing techniques in conjunction with their prescribed medications.

Bronchial asthma is a very common chronic disease marked by inflammation and constriction of airways, resulting in recurrent episodes of breathlessness, wheezing and decrease work of breathing. Breathing exercises help to manage hyperventilation associated with asthma. In order to manage respiratory conditions asthmatic patients are encouraged for nasal breathing techniques along with pharmacological management. Hence the objective of the study is to compare the effects of alternative nostril breathing along with pharmacological management versus pharmacological management alone on dyspnea, control pause, asthma control and peak expiratory flow rate in patients with bronchial asthma.

Eligibility Criteria:
Inclusion Criteria:

* Adults: aged (18-45 years)
* Gender: Both males and females
* Grade1- Grade 4 on Modified MRC dyspnea scale
* Asthma severity classes (intermediate, mild persistent and moderate persistent asthma) acc. to NAEPP national asthma education and prevention program guidlin

Exclusion Criteria:

* Patients having acute exacerbation of COPD or status asthmaticus
* Patients diagnosed with acute infections
* Patients unable to follow command/ instructions
* Asthma patients with \>40 sec control pause duration
* Patients who fall in red zone of asthma action plan (PEFR \< 50%)
Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study

Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide with increased rates of neonatal and maternal morbidity and mortality. Despite its frequency, very little is known about its pathophysiologic mechanisms. Mechanical strength is provided to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV are the main collagen types in these membranes. Studies have shown that total collagen content is reduced in the amnion of women with preterm PROM.

Vitamin C is involved in the metabolism of collagen and has been proposed to play an important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin E may play a synergic role with vitamin C, increasing the antioxidant capacity against reactive oxygen. Woods et al hypothesized that an increase in dietary consumption or supplementation of vitamin C and E during pregnancy might reduce the risk of that portion of preterm PROM that may be mediated by oxidative injury to fetal membranes. Plessinger et al report that pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous acid-induced membrane damage.

Borna et al. reported a randomized, double-blind controlled study of vitamin C and E supplementation, in which women with preterm rupture of membranes and singleton gestations at 26 to 34 weeks were randomized to vitamin C and E supplementation or placebo. Supplementation with vitamin C and E were associated with longer latency before delivery. However, the sample size in this study was very small.

The aim of this study was to evaluate the effect of supplementation with vitamins C and E after preterm premature rupture of membranes. We hypothesised that supplementation vitamins C and E may be effective in decreasing oxidative stress and increasing the latency period.


Eligibility Criteria:
Inclusion Criteria:

Patients with a single nonanomalous fetus and PPROM at ≥ 24.0 and ≤ 34.0 weeks' gestation.

Exclusion Criteria:

fetus with anomalies, chorioamnionitis, experienced PPROM within 14 days of either amniocentesis or cervical cerclage placement, multiple gestation, obstetrical indication for immediate delivery, delivery within 24 h of admission intrauterine fetal death at the time of presentation.

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