cyrilzakka/clinical-trials huggingface dataset:
Pre-operative Hypofractionated Proton Therapy

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures.

Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years of age)
* Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
* WHO/ECOG status ≤2

Exclusion Criteria:

* History of prior local radiation therapy
* Inability to tolerate treatment position for duration of simulation or treatment
* Tumor originating in retroperitoneal location
* Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
* Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
* Confirmed pregnancy.
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.

The protocol describes a randomized, fully-masked, parallel, placebo-controlled study of TDF for pre-exposure prophylaxis of HIV in high-risk women. TDF was selected for investigation as prophylaxis against HIV in high-risk women because of its unique pharmacological profile. In addition to the convenience of being a once daily single tablet, TDF's safety profile is comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it has low potential for selection of resistant viruses. TDF is cleared from the body by the kidneys and is not metabolized by the liver. Therefore, TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs. Each of these properties is necessary given the realities of the intended target populations. Moreover, initial prevention studies in simian models have provided encouraging results. Finally, the drug's sponsor is supportive of investigating the potential use of TDF as a preventive, as well as a therapeutic agent.

Participants' HIV status is monitored monthly. Participants are also monitored for safety using periodic physical examinations, serial laboratory tests and adverse event queries. Lab tests for kidney and liver function were to be conducted at screening, months 1, 3 and every 3 months thereafter or at the final visit if early withdrawal. To minimize the risk of contracting HIV infection, participants are counseled monthly to use male condoms for each act of intercourse. Participants converting for antibodies to HIV are counseled and referred to medical services as appropriate for each country.

Eligibility Criteria:
Inclusion Criteria:

* HIV seronegative
* Willing and able to give informed consent
* 18 years to 35 years old, inclusive
* Sexually active (on average, coitus 3 times per week)
* Have had more than three sexual partners in the last month
* Willing to use study product as directed
* Willing to adhere to follow-up schedule
* Willing to participate in the study for up to 12 months
* Not pregnant, breast feeding, or desiring a pregnancy during the 12 months of participation
* Have adequate renal function (serum creatinine \< 1.5 mg/dL)
* Have adequate liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
* Have adequate serum phosphorus (greater than or equal to 2.2 mg/dL)
* In general good health (no active, serious infections that require parenteral antibiotics; no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure

The investigators aim to examine how medical conditions that indicate high cardiometabolic risk, such as increased body weight, high cholesterol levels and high blood pressure, affect heart structure and function among individuals with known HF. Furthermore, this study is being undertaken to identify potential differences in these effects between non-Hispanics whites and Mexican Americans.

While it is known that Mexican Americans are inordinately affected by metabolic syndrome (MetS), it is unclear how metabolic risk factors impact left ventricular structure and function in Mexican Americans with HF. There is also a gap in the knowledge of the principal etiology of HF in this ethnic group. The overall objective of this pilot study is to define the association between MetS and and non-ischemic HF in Mexican Americans. Our central hypothesis is that there is a positive graded association between an increasing number of metabolic risk factors (ie. individual components of MetS) and increasingly compromised LV structure and function in this population, independent of blood pressure and CAD. Additionally, we hypothesize that this association is more pronounced than that seen in non-Hispanic whites suggesting a predominant role of MetS on HF among Mexican Americans. The rationale that underlies the proposed research is that, once the association between metabolic risk factors and HF in this ethnic group is defined, future research on the impact of management of these metabolic risk factors on HF outcomes, both among Mexican Americans and in the larger population, will be advanced.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-59 years
2. known diagnosis of HF
3. complete 2-dimensional and Doppler echocardiogram within the last 12 months.

Exclusion Criteria:

1. history of CAD determined by recorded or self-reported history of CAD and/or revascularization
2. recent history (previous 6 months) of decompensated HF
3. heart transplant
4. diagnosis of diabetes (rationale: diabetes independently predicts HF)
5. race/ethnicity other than Mexican American or non-Hispanic white.
Work of Breathing in Term Infants

This is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. We hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.


Eligibility Criteria:
Inclusion Criteria:

* Infants born ≥37 weeks gestation
* Admitted to the Mother-Baby Unit
* Within 24 hours of expected discharge

Exclusion Criteria:

* Infants born between \< 37week gestation admitted to the Mother-Baby Unit at CCHS
* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded.
Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log

Purpose of the study:

To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language.

The OPTIMAL assessment log was produced in English and later on it was being validated into Italian and Spanish versions. It hasn't been produced into Arabic yet so the aim of this study is to test the validity , reliability and psychometric properties of this assessment tool when being translated into Arabic and used among the Arabic Egyptian people.

Eligibility Criteria:
Inclusion Criteria:

1. Participants are adult outpatients who took at least a month of physiotherapy sessions.
2. Both genders will be included.
3. At least 18 years of age.
4. Participants must be conscious and ambulant.
5. Participants able to read, write Arabic as a mother tongue and understand the instructions, questions in the questionnaire.

Exclusion Criteria:

Participants having the following conditions will be excluded from the study:

1. Patients who are not able to provide informed consent.
2. Patients who are unable to complete the OPTIMAL instrument.
3. Patients who have a severe cognitive impairment.
4. Patients who are not receiving physical therapy.
5. Patients who are not Arabic-speaking.
6. Patients who have a history of malingering
Evaluation of Transperineal US in Labour

Assessment of progress of labour is an important step in decision making of obstetricians

delayed progress of labour resemble an annoying problem to obstetrician so noninvasive diagnostic methods can play an important role in implementing a guidelines to follow patients in labour as transperineal US .

Eligibility Criteria:
Inclusion Criteria:

* pregnant women in labour
* Full term

Exclusion Criteria:

* pregnant ladies not in labour
* Preterm labour
A Pilot Study of Creative Arts Interventions for Neurology Inpatients

The purpose of the study is to assess the feasibility of a Creative Artists Program intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical Center for care by the Department of Neurology.

Qualifying patients admitted to Epilepsy monitoring or Headache treatment will be approached for participation in the study. Patients who consent to the study will be given a chance to work with one of three creative artists (visual artist, creative writer, therapeutic musician). The artist will be selected according to a pre-determined schedule, and the arts intervention may last up to 90 minutes. Subjects will be asked to complete study questionnaires before and after the arts intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18 years
2. Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
3. Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
4. Capable of giving informed consent

Exclusion Criteria:

1. Active psychiatric illness that prohibits safe visitation by artists
2. Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
3. Active general medical condition that would impair consciousness.
24 Hour IOP Lowering Efficacy of AL-3789

The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant, intend to become pregnant, breastfeeding.
* Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
* Any form of glaucoma other than open-angle glaucoma.
* Other protocol-defined exclusion criteria may apply.
Mainstreaming a Life Skills Education Programme Right to Play- Plus to Reduce Violence Against Girls in Pakistan

Right to Play-Plus (RTP-Plus) aims to address violence against women and girls by promoting changes in social norms among young people within the school environment. The project focuses on building the capacity of young people to identify harmful gender norms and prevent violence against girls and boys by incorporating Right to Play's play-based learning methodology and Aahung's Life Skills Based Education curriculum. The strategies employed include interactive, learner-centered methodologies, curricular activities, and the development of peer educators and junior leaders. Teachers play a crucial role as key influencers and delivery agents of the curricular content. The project emphasizes capacity development for teachers, challenging their social norms, strengthening their play-based methodologies, and improving their sexual and reproductive health and rights knowledge (SRHR). The ultimate goal is to equip teachers to effectively deliver a gender transformative curriculum, empowering young people to respond to and prevent violence.

The research question for this study is:

What is the effectiveness of an adapted play-based life skills education that incorporates a "whole school" approach in reducing sexual harassment and abuse, peer violence experiences, mental illness (including suicidal ideation), improving resilience, and promoting gender equity, SRHR knowledge in both home and public settings?

The research objective will be achieved through two-arm cluster randomized controlled trial (for girls-only, co-ed, and boys-only schools). The intervention arm participants will be able to participate in the adapted play-based life skills education intervention, which the Right to Play and Aahung will deliver. It will be provided to all eligible school children in grade 6. Moreover, a delayed intervention will be offered to the control arm upon completion of endline data collection after the comprehensive intervention is delivered in the intervention arm.


Eligibility Criteria:
Inclusion Criteria:

* Schools will be chosen from District Malir and adjacent areas, including Korangi and East Karachi. Among the 100 selected schools, the following distribution will be maintained: 40 girls-only schools (public), 40 co-ed schools (private), and 20 boys-only schools (public).
* Schools having a minimum of 30 students enrolled in grade 6
* Private schools with low to medium fees, with monthly amounts ranging from PKR 2000 to 3500.
* Factors such as teacher availability, school management support, accessibility to research and intervention partners, and school clustering will also be considered for the selection of these hundred schools.
* Schools' willingness to adapt child protection and safeguarding/anti-harassment administrative measures and policies to improve school safety, reduce the use of corporal punishment, enhance school performance, and increase girls' retention rates, primarily apply to private schools.

Exclusion Criteria:

* Schools where Right to Play or Aahung have already implemented their play-based/other activities.
Effect of Turner Syndrome on Number Sense

This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents, and adult women with Turner syndrome.
* Healthy controls.
* Normal or corrected to normal vision.

Exclusion Criteria:

* Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).
* Chemical dependency
* Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.
Psychological Impact of the Covid-19 Pandemic on Student Nurses

The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

Describe the prevalence of post-traumatic stress disorder among student nurses 1 month after the end of the French epidemic Covid-19 peak

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old

Exclusion Criteria:

* Opposition to participate to the questionnaire
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

This study evaluates the efficacy of Pediatric Manual Therapy in the treatment of positional plagiocephaly in infants. 40 participants will receive a protocol of Pediatric Manual Therapy and educational physiotherapy in combination, while the other 20 will receive only educational physiotherapy

The Manual Therapy has shown efficacy in different pathologies in the adult but it is not know its utility in infants and children population, nor in specific pathologies as non synostotic plagiocephaly.

In the conservative treatment of plagiocephaly the educational physiotherapy and the helmet therapy have the better level of evidence among other treatments.

A protocol of ten sessions of Pediatric Manual Therapy will be applied to infants with positional plagiocephaly in combination with educational physiotherapy. The protocol consists in soft cervical mobilisation, myofascial induction and the application of some pressures to the cranial bones to improve the asymmetry of the head. Educational therapy which consists in more "tummy time" stimulation, stimulation to the non preference position of the head and counter positioning.

The control group will receive only Educational therapy.

Eligibility Criteria:
Inclusion Criteria:

* Sign of positional plagiocephaly
* Infants below 6 moths age

Exclusion Criteria:

* No neurological disorders
* No infectious diseases
* No respiratory diseases
* No other treatments
When Heparin Stopped for Anticoagulation During ECMO Decannulation

Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Heparin infusion is regulated to keep the whole blood activated clotting time (ACT) or activated partial thromboplastin time (APTT) at a designated level (usually 1.5 times normal for the ACT or APTT measurement system). An elevated ACT or APTT is associated with high risks of early and late complications,such as bleeding,hematoma,pseudoaneurysm,and arterial-venous fistula. Extracorporeal life support organization(ELSO) make recommendation that the cannulas can be removed ideally after the heparin has been stopped for 30 to 60 minutes.However,the Chinese Thoracis Society recommends that heparin should not be discontinued immediately before ECMO decannulation, but gradually reduced within 24 hours, and then low molecular weight heparin is continued to be given for anticoagulation. Therefore,options of which time heparin stopped remain controversial.The investigators conduct this pilot study to investigate the opportunity of heparin stopped for anticoagulation before ECMO decannulation.

Forty adult patients with cardiac or respiratory failure supported by ECMO are enrolled in the study. Patients are randomly allocated to be treated with either a) heparin has been stopped for 1 hour before ECMO decannulation(regimen A), b) heparin gradually reduced within 24 hours after ECMO decannulation(regimen B).The investigators hypothesize that patients treated with regimen A as compared with patients treated with regimen B would decrease the incidence of complications during the ECMO decannulation period(from 1 hour before ECMO decannulation to 72 hours post decannulation).

Eligibility Criteria:
Inclusion Criteria:

* ECMO therapy was instituted to support circulatory and/or respiratory failure;
* Heparin continuous infusion for anticoagulation during ECMO;
* Native cardiac and pulmonary function improve,and the trial off is successful.
* Ensure each patient provides signed and dated informed consent.

Exclusion Criteria:

* 1.History of thrombotic diseases or coagulation disorder；
* Thrombosis or bleeding events occurred prior to allocation；
* Heparin stopped prior to allocation；
* Other anticoagulants, antiplatelets, hemostatics and other drugs affected coagulation function have been used；
* The trial off has failed;
* Pregnant and lactating patients;
* Patients participated in the other studies;
* Patients couldn't accept comprehensive treatment;
* Patients couldn't acquire informed consent;
Pilot Study to Test Dietary Fat Delivery

The average American diet consumed by a significant proportion of the adult population, supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found in the blood, along with markers of poor muscle metabolism.

Both fats and amino acids are processed by the same metabolic pathways in muscle, and the investigators hypothesize that meals with greater amounts of saturated fat slow muscle metabolism. A better understanding of the interaction of these to metabolites will allow for the development of future medications to treat muscle loss in sick individuals and the elderly.

This study includes two parts, a baseline study and a three-week dietary study. The baseline study will be performed to test how the body absorbs and stores meal fat after a meal. In the three-week dietary study, the subjects will consume only the meals provided by the investigators for three weeks before the tests, and then participate in a hospital stay. The three-week dietary study is to test the chronic effect of a high fat diet on how body absorbs and stores the fat.

Eligibility Criteria:
Inclusion Criteria:

1. Lean/insulin sensitive (n=10, BMI ≤ 24 kg/m2 and glucose infusion \> 4.0 mg/min))
2. Overweight/obese insulin resistant (n=10, BMI 26-35 and glucose infusion \< 4.0 mg/min)
3. 30-50 years of age
4. Men and pre-menopausal women

Exclusion Criteria:

1. Insulin resistance is defined by insulin clamp as the rate of glucose infusion ≤ 4.0 mg/min.
2. BMI over 35 kg/m2
3. Abnormal thyroid function, kidney or liver disease
4. Uncontrolled hypertension, or occasional or regular smoker, use of medications or supplements that interfere with lipid, protein, or carbohydrate metabolism
5. Pregnancy (urine test), breast feeding an infant, or anemia
6. Alcohol intake: Males \>140 g/week, Females \> 70 g/week.
7. Fasting plasma triglycerides \>300 mg/dL. Extreme hypertriglyceridemia could be due to either elevations in very low-density lipoproteins or chylomicrons, either of which would impair our ability to resolve dietary metabolic processes.
8. Need to consume acetaminophen-containing medications on a regular basis.