cyrilzakka/clinical-trials huggingface dataset:
Do More, B'More, Live Fit

Physical activity (PA) in individuals with cystic fibrosis (CF) improves exercise capacity, slows decline in lung function, increases mucus clearance and improves health-related quality of life (HRQoL). Establishing and maintaining an exercise routine remains challenging and programs promoting PA in people with CF have poor participation. Moreover, while the positive effects of physical conditioning on lung function have been well reported, conventional measurements of lung function may lack the sensitivity to reveal improvement in mild lung disease.

This randomized control trial (RCT; N = 60) evaluates the Do More, B'More, Live Fit, a 6-month fitness program designed to optimize exercise habits of 12-21 year-olds with CF through structured exercises with personalized coaching, exercise equipment including the FitBit Flex, online support and motivational messages delivered electronically. The intervention incorporates fitness preferences and encompasses endurance, strength and flexibility exercises while adjusting to physical fitness needs. The hypothesis is that intervention participants will have increased and sustained engagement and better health outcomes compared to control group participants. The investigators' specific aims are to:

1. Increase daily PA and measures of fitness
2. Improve lung clearance index (LCI) and participant HRQoL
3. Demonstrate feasibility, accessibility and satisfaction of intervention using semi-structured interviews

The results of this pilot evaluation of the Do More, B'More, Live Fit program will offer novel insight into factors that sustain engagement in exercise programs and identify if LCI is an appropriate clinical outcome to assess PA interventions. Results will inform future RCT of interventions to optimize exercise habits of adolescents with CF.


Eligibility Criteria:
Inclusion Criteria:

* 12-21 year-old patients with a diagnosis of cystic fibrosis that are cared for at Johns Hopkins
* Participants must have smart phone and/or computer with universal serial bus (USB) access to set-up FitBit Flex

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) \< 40% predicted
* Individuals already participating in vigorous physical activity as assessed by the study team such as participating in year-round organized sports and/or aerobic exercise \>30 minutes more than 5 times/week may or may not be included in this study at the discretion of the PI and study team.
Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour

Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.

Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.

Despite of marked improvements in management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in Obstetrics. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.

Prophylactic oxytocin, commonly administered after fetal and placental delivery, has been shown to reduce the incidence of PPH. The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine. The effect of oxytocin is limited by the number and status of the oxytocin receptors. Increases in the dose of oxytocin will not necessarily improve uterine contraction, if receptors are not adequate in quantity and quality.This is the cause of patients exposed to oxytocin for labor augmentation, in whom oxytocin receptors are known to reduce both number and response to oxytocin. Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead. Alternative drugs include ergot derivatives and prostaglandins (carboprost and misoprostol). Although protection from PPH with ergot derivatives and prostaglandin appear to be similar, prostaglandins are associated with more side effects.

Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean section secondary to failure to progress in labour
* First stage of labour
* Received oxytocin for at least 4 hours

Exclusion Criteria:

* Require General Anesthesia
* Cardiac Disease
* Hypertension
* Predisposition to uterine atony and postpartum hemorrhage
Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects

food interaction, pharmacokinetics, safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* all participants in the study will range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-index)
* written informed consent in accordance with Good Clinical Practica and local legislation

Exclusion Criteria:

* Subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values
* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Subjects with known history of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects who have taken a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study
* Subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study
* Subjects who have participated in another study with an investigational drug within the last 2 months preceding this study
* Subjects who are unable to refrain from smoking on study days
* Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
* Subjects who drink more than 60 g of alcohol per day
* Subjects who are dependent on drugs
* Subjects who have donated blood (\>= 100 ml) within the last 4 weeks
* Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Diet Patterns in IBD in Central Texas

The purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with IBD in Central Texas.


Eligibility Criteria:
Inclusion Criteria:

* any patient 18years of age or older with inflammatory bowel disease

Exclusion Criteria:

* unwilling to participate
* diagnosis of IBD unable to be verified
The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants

Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.


Eligibility Criteria:
Inclusion Criteria:

1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
Effectiveness of Neuromuscular Kinesiology Taping in Plantar Fasciitis

One of the pathologies most studied and treated with kinesiotape (KT) is plantar fasciitis (PF). In most of the studies reviewed, it is concluded that there is an improvement in the symptoms of PF when treated with KT: either combined with other therapies or as a single treatment compared to placebo. However, most current studies have limitations because the sample is small, the effect size is small, and the evidence is insufficient or of low quality.

In the present work, the aim is to study the effectiveness of KT in PF, and to compare the results with those obtained in a placebo group, which is treated with tape. The researchers will assess the decrease in symptoms prior to performing other definitive treatments. In addition, the variability of the painful symptoms and the durability of the bandage will be studied, in order to determine whether it can be used in the short or long period of time, being able to take it into account and supposing a supplement to the pharmacological treatment.


Eligibility Criteria:
Inclusion Criteria:

* People with acute plantar fasciitis with less than 3 months of evolution
* Who present pain in the fascia both during ambulation and on palpation
* Ecographic image compatible with plantar fasciitis (\> 4 mm)
* The condition has not be previously treated with other treatment

Exclusion Criteria:

* Condition with no sintomatology
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

1. medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
2. euthymic at the time of conception;
3. able to give informed consent and comply with study procedures;
4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion Criteria:

1. active suicidality or homicidality;
2. active substance use disorder with 6 months prior to enrollment, or
3. positive urine drug screen at enrollment.
Pilot Study to Estimate the Burden and Distribution of Plasmodium Falciparum Malaria in Kalifabougou, Mali in Preparation for a Prospective Cohort Study of Naturally-Acquired Malaria Immunity

Plasmodium falciparum malaria remains a global public health threat. Leading malaria vaccine candidates confer only partial short-lived protection at best. An understanding of the mechanisms by which humans acquire malaria immunity through repeated P. falciparum infections may aid the development of a malaria vaccine. This pilor study is designed to initiate the epidemiological groundwork for a future prospective cohort study of acquired malaria immunity in Kalifabougou, Mali, a rural village of approximately 5 000 individuals who are exposed to seasonal P. falciparum transmission each year from July through December. This study will estimate the age-stratified point prevalence of P. falciparum infection before the malaria season and at the peak of the 6-month malaria season, and it will estimate the age-stratified incidence of symptomatic p. falciparum infection during the 6-month malaria season. The spatial distribution of asymptomatic P. falciparum infections and incident malaria cases within the village of Kalifabougou will be determined by merging the prevalence and incidence data with census and Global Positioning System (GPS) data....

Plasmodium falciparum malaria remains a global public health threat. Leading malaria vaccine candidates confer only partial short-lived protection at best. An understanding of the mechanisms by which humans acquire malaria immunity through repeated P. falciparum infections may aid the development of a malaria vaccine. This pilor study is designed to initiate the epidemiological groundwork for a future prospective cohort study of acquired malaria immunity in Kalifabougou, Mali, a rural village of approximately 5 000 individuals who are exposed to seasonal P. falciparum transmission each year from July through December. This study will estimate the age-stratified point prevalence of P. falciparum infection before the malaria season and at the peak of the 6-month malaria season, and it will estimate the age-stratified incidence of symptomatic p. falciparum infection during the 6-month malaria season. The spatial distribution of asymptomatic P. falciparum infections and incident malaria cases within the village of Kalifabougou will be determined by merging the prevalence and incidence data with census and Global Positioning System (GPS) data.

Eligibility Criteria:
* INCLUSION CRITERIA:

Cross-sectional Survey:

Individuals (ages 2-25 years) are eligible to enter the cross-sectional study if they agree to:

* Live in Kalifabougou for the next 5 months.
* Have blood specimens stored for future studies.

Passive Surveillance:

All individuals who live in Kalifabougou and present to the Kalifabougou health center with suspected malaria will be eligible to enroll in the passive surveillance component of the protocol.

EXCLUSION CRITERIA:

None.
Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical diagnosis of Alzheimer's Disease
* Must be at least 50 years of age
* Must fluently read and speak English
* Must have a reliable caregiver

Exclusion Criteria:

* Has serious health problems other than Alzheimer's Disease
* Cannot swallow whole pills
* Has had a menstrual period in the last two years
* Takes insulin for diabetes
* Has taken Aricept, Reminyl, or Exelon in the last 5 weeks
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)

The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants


Eligibility Criteria:
Inclusion Criteria:

* Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
* Participants at least 20 years but under 65 years of age;
* Caucasian participants ;
* Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
* Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

* Participants in whom a difficult intubation because of anatomical malformations was expected;
* Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level \> 1.6 mg/dl) and/or severe hepatic dysfunction.
* Participants known or suspected to have a (family) history of malignant hyperthermia;
* Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
* Female participants who were pregnant;
* Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
* Participants who were breast-feeding;
* Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
* Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals

Aim: To explore

* the frequency of use of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia
* the incidence of residual neuromuscular blockade, and
* the timing of reversal of the neuromuscular blockade at the end of anaesthesia.

We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia Information Management System (AIMS).


Eligibility Criteria:
Inclusion Criteria:

Patients who received general anaesthesia with neuromuscular blockade in one of the 7 hospitals providing data for the study in the last 18 months up until the time of data collection
Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Resident of Petersburg, VA
* Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself

Exclusion Criteria:

* A diagnosis of type 1 diabetes mellitus.
* Currently being treated for cancer.
* Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
* Hospitalization for depression or other psychiatric disorder within the past 12 months.
* Lifetime history of bipolar disorder or psychotic disorder.
* Currently pregnant or lactating, or planning to become pregnant within the study period.
* Current involvement in a weight loss program or current use of weight loss medication.
* Inability to speak, read and write English.
* Planning to move from the Petersburg area within the study period.
* Does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.

Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.

Eligibility Criteria:
Inclusion Criteria:

* Children been born between 15/01/08 and 15/01/10
* children whose term is lower than 28 weeks of amenorrhoea

Exclusion Criteria:

* Born child superior to 28 weeks of amenorrhoea
* presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Antaitavir Hasophate.


Eligibility Criteria:
Inclusion Criteria:

* signing of informed consent
* Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Exclusion Criteria:

* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
* Positive results from urine drug screen test
* Donate blood or lose blood 400 mL or more within 3 month prior to dosing
* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection
Comparison Of Effectiveness of Mobilization With Movement (MWM) and Kelternborn Treatment Technique to Increase ROM, Reducing Pain in Patient of ACL Reconstruction

To determine the Comparison Of Effectiveness of Mobilization With Movement (MWM) and Kelternborn Treatment Technique to Increase ROM, Reducing Pain in Patient of ACL Reconstruction


Eligibility Criteria:
Inclusion Criteria:

* • Subjects with age group between 20 to 60 years with sedentary lifestyle were included.

  * Both males and females were included.
  * Patients with diagnosed Tight hamstrings having knee extension less than 160º with the hip at 90º flexion.
  * Patients with decreased ROM at the knee joint.
  * Patients with reduced straight leg raise.
  * Patients with pain in posterior compartment of thigh.
  * Asymptomatic patients will be included.

Exclusion Criteria:

* • Patients with prolapsed disc were excluded.

  * Patients with lower extremity injuries (strain, sprain, ligament injuries, etc.) in last 6 months were excluded.
  * Patients with severe hamstring injury either acute or chronic were excluded.
  * Patients with visual acute swelling in the region of hamstring muscle
  * Patients with fracture of any type and area.
  * Patients with dislocations or subluxations present were excluded.
  * Patient recommended for TKR of knee joint.
  * Patients with any neurological disease like lumbar/cervical herniation, polyneuropathy, scoliosis etc.)