cyrilzakka/clinical-trials huggingface dataset:
Examining Physician Counseling to Promote Adoption of Physical Activity: A Controlled Trial

The purpose of this study is to systematically test the efficacy of two physician-based interventions in changing physical activity patterns of adults over a 20-month period.

Although physicians typically counsel for other risk factors of CVD, they are less likely to counsel for increasing levels of physical activity. This is surprising for two reasons: First, physical activity has been identified as an independent modifiable risk factor for CVD. Second, there is a high prevalence of physical inactivity among Canadians. The purpose of the current study is to examine interventions that are designed to promote adoption and maintenance of physical activity through physician recommendations and counseling. The primary outcome measures include possible differences in levels of self-reported physical activity. In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits \& enjoyment, and barriers). There are several unique aspects to this research including: 1) the fact that it compares two types of delivery systems 2) the examination of physical activity patterns over an extended period of time has not been done previously with this type of intervention, and as such, also forms another unique feature of this proposal 3) physician intervention for physical activity has not been done in Canada previously. If the intervention is found effective, the program will add significant value to health services in Saskatchewan and Canada. For instance, the program will enhance the role of physicians in promoting physical activity without increasing the cost of health-care delivery, and with a minimal investment of time required by the physician and his/her staff.

Comparison: To assess the efficacy of the interventions, a quasi experimental design will compare an intervention with a standard control condition. All physicians will be trained to use a standardized protocol to deliver PACE exercise counseling to sedentary patients during one office visit. In the intervention condition, patients will be randomly assigned to receive reminder calls from a research assistant who will provide suggestions as to possible physical activity resources in the community that could be used.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory adults

Exclusion Criteria:

* cardiovascular disease
* respiratory disease
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18-65 years of age inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 30 mg/m2 inclusive
* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

* Evidence of any active or chronic disease
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
* History or presence of clinically significant psychiatric condition
* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study
Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.

A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.

A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early OT plus ASDM.

The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years.
* Need for hospitalization in ICU.
* At least 12 h of invasive mechanical ventilation
* Informed consent signed by legal representative and / or patient.
* Positive covid-19 diagnosis

Exclusion Criteria:

* Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores\> 3.3 were excluded.
* Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as \> 6 points.
* Severe communication disorder and cultural limitation of language (language different from Spanish)
* Patient with limited therapeutic proportionality.
* Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
* Spinal injury or unstable fractures that limit mobilization
Loaded Vs Unloaded Sit to Stand Strengthening Exercises in Children With Cerebral Palsy

Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.

The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.


Eligibility Criteria:
Inclusion Criteria:

* Spastic diplegic cerebral palsy
* Age between 6 to 12 years
* Children with GMFCS level I and II
* Able to stand up from chair independently and maintain standing for more than 5 second without falling.
* Had not received any strengthening exercise program in past 3 months
* Parental commitment to allow participation without altering current activity

Exclusion Criteria:

* Participants with epileptic history and lower limb contractures are excluded
* Those who are unable to follow verbal command
* Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
* Orthopedic condition or medical problems that prevent children from participating in exercise
Pentoxifylline Add-on Therapy for Schizophrenia

The etiology and pathogenesis of schizophrenia remain unclear. The immune dysfunction hypothesis for schizophrenia has attracted increasing attention from researchers, and substantial evidence suggested that the levels of TNF-α and other cytokines are markedly elevated in patients with schizophrenia. The investigators aim to evaluate the adjuvant therapeutic effect of Pentoxifylline, a TNF-α inhibitor that crosses the blood-brain barrier, in a randomized, double-blind, 6-week trial. Individuals with schizophrenia will receive either Pentoxifylline or a matching placebo as an add-on treatment to antipsychotic agents. Subjects' positive and negative symptoms and plasma concentration of neuroinflammatory markers will be monitored at baseline and every two weeks until the end of the trial.

Ninety schizophrenic patients will be randomized to a Pentoxifylline (400 mg twice a day) or placebo treatment for six weeks. Pentoxifylline and placebo will be added to the current antipsychotic drug treatment. Participants will be asked to fill a socio-demographic questionnaire and to undergo a clinical differential diagnosis using the Symptoms Check List (SCL)-90, Clinical Global Impression (CGI), positive and negative symptoms scale (PANSS), and Hamilton depression rating scale (HAM-D). Following baseline evaluation, participants will be monitored for symptoms every two weeks until the end of the trial (overall three visits) using CGI, PANSS, and HAM-D. Adverse effects will be documented every visit using the Treatment Emergent Symptom Scale. Finally, yet importantly, a blood sample will be collected at baseline and every two weeks until the end of the trial to study the treatment effect on inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

1. Patients meeting the DSM-V criteria for schizophrenia spectrum disorders.
2. Clinical Global Impression (CGI) score ≥ 4 and ≤ 6 at screening.
3. Initiated treatment with a stable dosage of typical and/or atypical antipsychotic medication for at least four weeks.

Exclusion Criteria:

1. Previous sensitivity to pentoxifylline (PTF).
2. Chronic immune and/or inflammatory diseases (such as rheumatoid arthritis, systemic lupus erythematosus, chronic inflammatory bowel disease).
3. Consumption for \> 3 consecutive days of any immune-modulating or anti-inflammatory drug in the last month.
4. Current active and persistent substance and/or alcohol abuse.
5. Any severe, unstable medical condition (e.g., cardiovascular disorders, diabetes mellitus, respiratory diseases, cancer).
6. Obesity (body mass index \> 30).
7. Cognitive dysfunction such as retardation.
8. Known or suspected pregnancy or breastfeeding women.
9. Lactose intolerance or sensitivity.
Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy

Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.

Flexibility of hamstrings was evaluated by Popliteal Angle test. Performance was evaluated 6 Minute Walk Test (6 MWT). Regression of hamstring flexibility and performance was examined regression tests. Correlation was examined between popliteal angle test and parameter of North Star Ambulation Assessment.

Eligibility Criteria:
Inclusion Criteria:

* To be a Duchenne Muscular Dystrophy diagnosis,
* Being in the ambulatory period and climbing four steps independently,
* to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test
* To be able to cooperate
* No any severe contracture in the lower limbs which may prevent assessments,

Exclusion Criteria:

* Children who fail to meet these criteria study.
Effect of Formal Contraception Handouts

The hypothesis of this study is to determine if distribution of a standardized educational handout on contraceptive options given to patients in the prenatal office setting will increase contraception use six months postpartum.

Reducing unintended pregnancies and those that are conceived within 18 months of a previous livebirth is an important health concern in the United States. Both unintended and close-interval pregnancies constitute 40% and 35% of pregnancies in the United States respectively with some overlap between the two categories and are associated with adverse maternal and fetal outcomes. A national survey found that 17.8% of women using 'less-effective' methods and 23% of women using no birth control became pregnant in ≤18 months2. Access to better contraception education could potentially decrease the proportion of unintended pregnancies and close-interval pregnancies. In addition to the health concerns, 58% of women in the US would like more information about contraceptive options, and organized handouts on birth control have been shown to contribute to the choice in birth control. However, there has been conflicting evidence about which educational methods increase postpartum contraception use. Therefore, the investigators propose a randomized controlled trial (RCT) that assesses whether a handout on contraception options increases postpartum birth control use. The control group would receive a nutrition handout, and the intervention group would receive a handout on birth control options in addition to each receiving the standard of care. The researchers would also give pre- and post-natal questionnaires, covering patient satisfaction, intention to use birth control, and how often a provider discusses birth control options.

Eligibility Criteria:
Inclusion Criteria:

1. Women who are pregnant and are 24-28 weeks gestational age at the time of recruitment
2. Women \>18 years of age
3. Women with low-risk pregnancies

Exclusion Criteria:

1. Women who receive prenatal care by the Maternal Fetal Medicine department for high-risk pregnancies
2. Women who are members of an at-risk population including any women who is a prisoner, cannot provide consent, or is \<18 years of age
3. Non-English speaking
Cystatin C and Uncontrolled Hypertension

Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and kidney functions are known to be closely related. Increased serum level of Cystatin C, a sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The investigators aimed to evaluate the predictive value of serum Cystatin C for control of hypertension in a community-based study.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who accept to participate to the survey
* \> 18 years

Exclusion Criteria:

* Individuals who are not able to complete the questionnaire
* Individuals who didn't give informed consent
Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection

This study aims to investigate the effects of comparing early versus late referrals for scapular-focused exercise on shoulder function in head and neck cancer patients following neck dissection.

This study will recruit 30 head and neck cancer patients with spinal accessory nerve shoulder dysfunction based on the timing of referral, which will be divided into early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups. Both groups will receive conventional physical therapy (e.g., shoulder joint mobility training, electrical stimulation, or laser therapy for pain relief) and scapular-focused exercises. Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria

1. Age between 20 and 65 years.
2. Newly diagnosed with head and neck cancer and experiencing clinical symptoms of accessory nerve dysfunction after unilateral neck dissection, such as shoulder drooping, restricted active range of motion in shoulder abduction, or insufficient muscle strength against gravity in shoulder abduction.
3. Scapular dyskinesia, such as asymmetrical scapular movement in multiple planes.
4. Scapular asymmetry, defined as a bilateral difference of more than 1.5 cm between the inferior angle of the scapula and the spinous process of the seventh thoracic vertebra when performing 90° shoulder abduction in the scapular plane under a 1 kg load.

Exclusion Criteria：

1. Presence of distant metastasis or cancer recurrence.
2. Inability to communicate or comprehend the questionnaire.
3. History of shoulder pain within one year before neck dissection.
4. Any condition that may affect motor performance.
5. History of neuromuscular disorders or tendon pathology in the affected shoulder, other than accessory nerve dysfunction.
Testing Video Information About Mammography Screening

This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.

This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.

The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.

Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Participants eligible for the study includes all men and women age 18-75.

Exclusion Criteria:

* None
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 years of age and above on the day of enrollment;
2. Individuals in good health
3. Individuals are able to comply with all study procedures
4. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

1. Individual not able to comprehend and to follow all required study procedures;
2. History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
3. Any serious chronic or progressive disease according to judgment of the investigator
4. History of any anaphylaxis, serious vaccine reactions, to any excipients.
5. Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
6. Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
7. Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
9. Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
10. Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
11. History of progressive or severe neurological disorders;
12. Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
13. Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
14. Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
15. Members of the research staff or their relatives.
Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity

Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published.

The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent.

Exclusion Criteria:

* Pregnancy
* Unwillingness to sign the informed consent.