cyrilzakka/clinical-trials huggingface dataset:
Perception of Physical Exertion in Healthy Weight and Obese Adolescents

Little is known regarding the relationship between perceived and physiological exertion in adolescents. The purpose of this study is to investigate the association between physiological and perceptual markers of effort during exercise and the relationship of these markers to other health-related behaviors in healthy weight and obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Healthy weight (\>5th-85th BMI percentile) or obese (\>95th BMI percentile)
* male and female adolescents, 13-18 years
* Approval to participate in a submaximal and maximal treadmill test received from the adolescent's pediatrician.

Exclusion Criteria:

* Underweight (\<5th BMI percentile)
* overweight (85 - \<95th BMI percentile)
* evidence/reporting of significant cardiovascular disease, cardiac arrhythmias, liver disease, or the chronic use of medications including diuretics, steroids and adrenergic-stimulating agents.
* Adolescents with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions.
* Approval to participate in a submaximal and maximal treadmill test from the adolescent's pediatrician not obtained
Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.


Eligibility Criteria:
Inclusion Criteria for control group :

* major pregnant women
* singleton pregnancy

Inclusion Criteria for control group :

* major pregnant women
* singleton pregnancy
* hospitalized for threatened premature birth between 24 and 34 WA
* Indication of a cure corticosteroid betamethasone

Exclusion Criteria:

* maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia
* fetal lung diseases
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
* Biopsy-proven squamous cell carcinoma.
* Will receive treatment with proton radiation.

Exclusion Criteria:

* Evidence of distant metastasis.
* Previous irradiation for head and neck cancer.
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries

There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

Pelvic organ prolapse (POP) can be defined as the protrusion of the pelvic organs out of the vagina. Many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. POP causes various undesirable effects in terms of sexual life and body aesthetics in women. With the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common.

Patients who had laparoscopic pectopexy operation due to minimum POPQ stage 2 according to the International Classification of Pelvic Organ Prolapse Quantification (POP Q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. In the first group, patients who had laparoscopic pectopexy operation were planned to be included. In the second group, it was planned to include patients who had ls lateral suspension operation.

Demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op Pelvic prolapse (with POP-Q classification), PopQ values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. Furthermore, the patients will be called back and Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PİS-Q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,

  * Being a Citizen of the Republic of Turkey over the age of 18
  * Patients operated by the same experienced surgeons

Exclusion Criteria:

* To have received chemotherapy and/or radiotherapy for any reason before
* Having previously operated for prolapse
* Cases with Contraindications for Laparoscopy
* Cases with severe cardiovascular or respiratory disease
A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a solid malignancy that is refractory to standard therapy or for which no standard therapy exists.
* Patients has a good performance status (ECOG 0 or 1)

Exclusion Criteria:

* Prior treatment with either pemetrexed or SU011248.
* Coughing up blood within 4 weeks before starting study treatment (small amounts okey).
* Hypertension that cannot be controlled by medications.
Standard Care Coordination Expansion Pilot

The Standard Care Coordination (SCC) solution integrates aspects of case management \& care coordination \& was designed by UnitedHealth Group for high-cost, complex, at-risk consumers to facilitate health care access and decisions that can have a dramatic impact on the quality and affordability of the consumer's health care. Currently members only receive the SCC if they are: 1) identified as high risk for readmission upon discharge from the hospital, 2) are self-referred, or 3) are directly referred to the program by their physician. The current quality improvement study was designed as a randomized controlled trial to determine if the expansion of the SCC program to commercially insured members identified via a proprietary administrative algorithms as being at high risk would significantly impact rates of acute inpatient admissions.


Eligibility Criteria:
Inclusion Criteria:

* UnitedHealthcare commercial Fully Insured members; all states; 18+ years old; actively enrolled in the health plan as of randomization identified via proprietary administrative algorithm as being at high risk for persistent super utilizer status.

Exclusion Criteria:

* : pregnant women, individuals prescribed medications for infertility, members with evidence of dementing disorders, members indicated as "do not contact " for program outreach, and Members in the following products and plans:

  * legacy UHC ASO groups (populations for which UHC provides administrative services only),
  * legacy Oxford health plan members (all members receive the SCC program),
  * legacy PacifiCare members,
  * legacy River Valley/NHP members, and
  * Public Sector clients
  * the PHS 2.0 intervention (a small population within Fully Insured)
  * assignment to a clinically activated Accountable Care Organization (ACO)
HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

Observational, single-center, prospective case-control study, in which each patient is his own control.

It focuses on the study of tubal patency and establishing the agreement of results between HyFoSy and HSG.

Observational, single-center, case-control study in which tubal pathology is studied in the context of a Basic Sterility Study.

The main objective of this study is to demonstrate the concordance of this new diagnostic test (HyFoSy) with HSG, which is the common technique to visualize tubal patency. Once demonstrated concordance, we also want to carry out a cost-effectiveness study and demonstrate through different scales the greater ease of the test, less time to perform and less pain for the patient.

It is a study in which the patients are women between 18-39 years old, undergoing study for primary sterility, with a BMI \<30, AMH\> 0.6 (good ovarian reserve).

Eligibility Criteria:
Inclusion Criteria:

* Women between 18-39 years, under study for primary sterility, with BMI \<30, AMH\> 0.6 (good ovarian reserve), subsidiaries of Conjugal or Donor IA, according to the 2019 SAS Reproduction Guide.

Exclusion Criteria:

* Women \<19 or\> 39 years old, BMI\> 30, secondary sterility, previous tubal sterilization, that is, the ART exclusion criteria according to the 2019 SAS Reproduction Guide.
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
* If patients were jaundiced, bilirubin had to be \>80 μmol/L.
* Male or female patients over 18 years of age.
* World Health Organization (WHO) performance status of 0 to 2.
* Patients with a life expectancy of at least 8 weeks.
* Patients must have given written informed consent.

Exclusion Criteria:

* Patients undergoing a potentially curative resection.
* Jaundiced patients with a bilirubin value \<80 μmol/L.
* Patients not considered fit for endoscopic or percutaneous biliary stenting.
* Patients receiving any other anti-cancer therapy.
* History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
* Females who were pregnant, planning to become pregnant, or who were lactating.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
* Previous G17DT treatment.
* Haematological indicators:

Haemoglobin (Hb) \<10.0 g/dL. White cell count (WCC) \<4.0×109/L. Platelets \<100×109/L.
Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

The ELITE trial is a prospective randomized controlled trial (RCT) to compare competent EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) \< 9 and short ambulance transport times (\< 20 min) to hospital.

The study aims to establish if advanced airway management with endotracheal intubation (ETI) in the field by specially trained Emergency Medical Services (EMS) physicians - compared to endotracheal intubation (ETI) performed by physicians in the emergency department in the same group - improves outcome in terms of 30-day mortality, degree of disability at discharge, complications and length of hospital stay, and neurologic outcome at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years)
* Initial GCS \< 9 independent of cause.
* Intact airway reflexes and no impending airway obstruction.
* Located \< 20 min ambulance transport time from nearest hospital emergency department.

Exclusion Criteria:

* Pediatric patients (under 18 years).
* Primary cardiorespiratory arrest (of non-traumatic / medical cause).
* Planned helicopter transport to hospital.
Magnetic Resonance Imaging in Treating Children With Progressive Low-Grade Astrocytoma

RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma.

PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.

OBJECTIVES: I. Determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. II. Improve the quality of life without use of aggressive surgery or radiotherapy in this patient population.

OUTLINE: Patients undergo magnetic resonance spectroscopic imaging (MRSI) over 60 minutes prior to surgery and/or radiotherapy. Patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. Arm I: Patients undergo conventional surgery. Arm II: Patients with inaccessible tumors undergo focal radiotherapy. Following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with MRSI or MRI for tumor response and growth.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on T2 weighted scans Incomplete surgical resection Previously treated with evidence of tumor progression No hemispheric or cerebellar masses

PATIENT CHARACTERISTICS: Age: 12 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency

It is the aim of the study to prove, if intravenous supplementation with ferric carboxymaltose in iron-deficient patients with heart failure with reduced ejection fraction (HFrEF) leads to better exercise training effects compared to exercise training without previous iron supplementation.

In patients with heart failure with reduced ejection fraction (HFrEF) exercise training (ET) is recommended. In iron-deficient HFrEF patients iron supplementation by ferric carboxymaltose (FCM) is recommended. Both treatment options (ET and iron supplementation) affect oxidative metabolism.

In this study iron-deficient HFrEF patients are included and randomly assigned to two study arms:

Study arm A: Intravenous iron supplementation with FCM, subsequent (after 2 months) ET program.

Study arm B: ET program, subsequent (after 2 months) intravenous iron supplementation with FCM.

Primary study endpoint is exercise capacity (Peak VO2). Secondary endpoints are 6-minute walking distance, NYHA class, echocardiographic parameters and the combined endpoint cardiovascular hospitalizations and death.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with reduced ejection fraction ≤ 40%
* New York Heart Failure Asssociation class II-III
* Iron deficiency (ferritin \< 100 ng/ml or 100-299 ng/ml, if transferrin saturation \< 20%)

Exclusion Criteria:

* Planned cardiovascular interventions (such as bypass surgery or valve interventions)
* Acute coronary Syndrome
* Malignant rhythm disturbances
* Acute or chronic infection
* Reduced prognosis or exercise capacity by non-cardiac comorbidities
* Missing informed consent
Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation

This study compared the learning curves and outcome of Laparoscopic Distal Pancreatectomy between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes.

Learning curves of laparoscopic distal pancreatectomy (LDP) are mostly based on 'pioneering' surgeons who acquired sufficient proficiency largely through self-teaching. No learning curves have been investigated for early adopting surgeons who performed surgery in later stages of the IDEAL framework and build on the experience of the 'pioneering' surgeons. This study compared the learning curves and outcome of LDP between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes over a period from 1997-2019.

Eligibility Criteria:
Inclusion Criteria:

* The collected data included the name of the surgeon so inclusion criteria for participating surgeons could be determined. Surgeons who were experienced with a minimum of 40 LDPs in total with at least 10 LDPs per year and who performed their LDPs in the same institution (i.e. no outside institutions) were included.

Exclusion Criteria:

* None
Assessing Open Access Audio

The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. Easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or sharing with caretakers and family. It has been introduced and tested outside the VA with evidence that it increases patient recall and understanding and may even improve physician performance. Little is known, however, about whether and to what extent these effects lead to better outcomes, such as improved treatment plan adherence and chronic disease self-management. This study is a randomized controlled trial designed ascertain whether easy access to audio recordings of the medical visit improves patients perception that they understand and can manage their own care, and leads to a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer emergency department visits and hospitalizations.

The study aims to assess (1) the impact of an open access audio (OAA) program on two behaviors (patient activation, treatment plan adherence), and two chronic condition measures (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider communication and on their attention to patient contextual factors (i.e. individual Veteran's needs and circumstances relevant to planning effective care); and (3) patient, provider, and leadership perceptions of the extent to which the program is safe, not burdensome, and worthwhile at both the start and at two years into the program. A secondary analysis will descriptively measure the effect size of OAA on ED visits and hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* All patients with scheduled appointments at the participating sites: primary care and diabetes clinics at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA Medical Center

Exclusion Criteria:

* None
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC stage IIIA-IIIB
* Performance status 0 or 1 (Zubrod or WHO Scale)

Exclusion Criteria:

* Evidence of metastases either in a separate lobe of the lung, or extra thoracic
* Patients with high risk of radiation pneumonitis and or compromised lung function
* Estimated life expectancy of less than 3 months
* Prior chemotherapy for lung cancer
* Prior radiotherapy to the chest
* Prior surgery with curative intent for lung cancer
Paraprofessional Treatment of Depression in Vietnam

Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.

This project focuses on evaluation of a collaborative care system for treatment of depression in Vietnam. This system involves training para-professional health care workers in a stepped-care model system of depression care to be implemented in commune health stations in Vietnam.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18
2. Depression Diagnosis

Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population

To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population.

To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects

Eligibility Criteria:
Inclusion Criteria for Subjects 9 - 40 Years of Age:

* Healthy
* Properly informed about the study and having signed the informed consent form
* Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Inclusion Criteria for Subjects 6 Months - 8 Years of Age:

* Healthy
* Parents have been informed properly regarding the study and signed the informed consent form
* Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>= 37.5 C )
* Known history of allergy to egg and or chicken protein or any component of the vaccines
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
* Pregnancy \& Lactation (Adult)
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
* Subject already immunized with influenza vaccine within 1 year.
* Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.