cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.

Eligibility Criteria:
Inclusion Criteria:

* No standard options remaining
* Adequate liver and kidney functions
* 18 years of age or above

Exclusion Criteria:

* History of any secondary active cancer in the last 3 years.
* Pregnant or breast feeding
* History of severe allergic reactions or contraindications to cetuximab or irinotecan
Heart Failure Worsens Muscle Strength in COPD

The combination of heart failure (HF) and chronic obstructive pulmonary disease (COPD) is highly prevalent, but underdiagnosed and poorly recognized. It has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. In addition, it is recognized that both diseases have several mechanisms that are responsible for musculoskeletal impairment. However, the association of reduced systemic perfusion with low oxygen content observed in the association of HF and COPD may contribute to the worsening of the components of the muscle impairment cascade. Thus, muscle strength and fatigue may not only be even more altered but may also be the main determinants of functional capacity in patients with coexistence of HF and COPD. Although many studies have evaluated the muscle performance of patients with HF or COPD, the literature did not show data on worsening due to the association of the diseases. Particularities identification of the muscle impairment in the coexistence of HF and COPD is fundamental for the development of rehabilitation strategies, mainly through physical exercise. In this line, the present study tested the hypothesis that the coexistence of HF and COPD could present lower values of strength and greater fatigue. Similarly, the muscle dysfunction degree could strongly correlate with the performance markers of the incremental or functional tests in patients with HF associated with COPD.

The study protocol was reviewed and approved by the Institutional Research Board. All subjects gave written informed consent before participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* non-cachectic sedentary patients
* moderate-to-severe COPD according to GOLD classification (FEV1/ FVC \<0.7 and predicted post-bronchodilator FEV1 between 30% and 80%)
* no clinical or echocardiographic evidence of HF for the COPD group
* echocardiographic evidence of HF with reduced left ventricular ejection fraction (\<40%) for the overlap group
* chronic dyspnoea (MRC scale score 2-4)
* NYHA class 2 or 3.

Exclusion Criteria:

* long-term O2 therapy
* recent (within a year) rehabilitation program
* osteomuscular limitation
* type I or non-controlled type II diabetes mellitus
* peripheral arterial disease associated with claudication
* Patients with preserved ejection fraction HF
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children

The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.

Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:

* Awake: the LMA was left in place until the patient fully regained consciousness
* Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.

Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for minor surgery

Exclusion Criteria:

* None
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
* History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Babies for which birth weight is \< 2 kilogram.
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure

This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of planned surgery.
* Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients requiring surgical treatment at more than 2 lumbar levels.
* Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
* Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.
* Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
* Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.
A Prospective Pharmacodynamic Study of Dabigatran

The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.


Eligibility Criteria:
Inclusion Criteria:

• Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days

Exclusion Criteria:

* CrCl \< 15 ml/min
* Non-FDA approved dose based on calculated CrCl with most recent SCr
* Age \< 18 years
* Inability to communicate in the English language
* Decisionally-impaired individuals
* Incarcerated
* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)
Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment

C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:

1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.

After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma.


Eligibility Criteria:
Inclusion Criteria:

For providers:

* Clinically active and seeing patients;
* Having a device with Internet access to use the OASIS prototype
* English speaking
* Willing and able to complete data collection activities.

For patients:

* Diagnosed OUD
* Unmet substance use treatment need
* Has an upcoming primary care visit scheduled for the intervention period (1-2 months)
* English speaking
* Has access to a device with Internet access to use the OASIS prototype
* Willing and able to complete data collection activities

Exclusion Criteria:

Patient participants will be excluded from this study if they:

1) Currently receiving or have received medication for opioid dependence.
Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study

Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Therefore, the purpose of this study is to estimate the progression rates to impair glucose regulation and diabetes in the Korean population-based Korea national Diabetes program.


Eligibility Criteria:
Inclusion Criteria:

* fastic serum glucose \>100 and/or pp2 serum glucose \<200

Exclusion Criteria:

* known diabetes
* organ failure(For example, liver, kidney)
* known malignancy
Housing Transitions QUERI

The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case management for homeless-experienced Veterans undergoing housing transitions. This Partnered Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case management aftercare sites across the nation.

The VA Grant and Per Diem case management (GPD-CM) program provides six months of case management for homeless-experienced Veterans (HEVs) undergoing housing transitions. At present, no specific case management paradigm is required in the GPD-CM program, resulting in practice variation across sites. This Partnered Implementation Initiative (PII) implements Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-at 32 VA GPD-CM sites. The investigators will use the Replicating Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites. Half of these sites will also receive 9 months of external facilitation (enhanced REP) as additional support for CTI implementation. In a type 3 hybrid trial, the investigators will use mixed methods to examine the impacts of REP versus enhanced REP. Using trial data, the investigators will develop a business case analysis and implementation playbook for the investigators' program partners to support continued CTI spread and sustainment in the GPD-CM program.

Eligibility Criteria:
Inclusion Criteria:

* Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated Service Networks (VISN), all of whom provide 6-months of case management to Veterans who have experienced homelessness.

Exclusion Criteria:

* None
Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer.

Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.


Eligibility Criteria:
Inclusion Criteria:

* Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy
* Women between ages 40-74 with dense breasts having a mammogram
* Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model).

Exclusion Criteria:

* Women with metallic implants
* Women that are claustrophobic
* Women that have a fear of needles or contrast
* Women that have had an allergic reaction to contrast in the past
* Women that are pregnant
* Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)
Caudal vs. Pudendal Block in Peds GU

This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing penile genitourinary surgery
* ASA class 1-3

Exclusion Criteria:

* Female patients
* Male children \<6 months or \>/= 3 years of age
* ASA class \>3
* Surgery at satellite location (non-Prentiss)
* Concurrent non-lower GU tract surgery
* Sacrospinal abnormality
* History of chronic pain requiring opioid analgesics
* Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics
* History of malignant hyperthermia
* History of coagulopathy
Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313

This study collects intra- and postoperative data from the patients´charts retrospectively and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO) following implantation of the intraocular lens L 313.

This study is a postmarket study without interventions. Within the Standard Care Cataract surgery the participants have been implanted with the intraocular lens L313 in the period between September 2009 and December 2013. As criterium for the PCO was considered the Nd:YAG capsulotomy.

In the first step of the study, data was collected from the patients´charts.

In the second phase, a questionaire was sent to the patients with no recent examination, asking them to answer whether or not participants received a laser procedure due to PCO. In doubt the participants could answer: "I am not certain". For this step the investigator ensured the positive Votum of the Ethic Committee of the University of Greifswald, Germany.

On the third step of the study, the patients that were not certain of having such a laser procedure or did not answer per post, will be contacted on telephone. By uncertainty or no answer on the telephone the family eye doctor will be contacted to receive the necessary information. If the eye doctor has lost contact to the patient, then this patient will be documented as lost-to-follow-up.

Excluded were the patients that live \>50km from the Department of Ophthalmology in Neubrandenburg, as well as patients with intraoperative capsule tear.

For the statistical analysis was used the program STATISTICA (StatSoft, Hamburg, Germany) and the survival analysis using the Kaplan-Meier formula, the statistical significance using the Chi-squared test and Spearman-Rank corelation and the Bonferroni adjustment if the test was repeated.

The investigators compared these results with the results of other publication. In order to do that the investigators calculated the capsulotomy quote from this study according to the time of the PCO recorded on the other studies. Included were only comparing studies that also used YAG-capsulotomy as criterium for the PCO.

Furthermore secondary data was collected: age, gender, cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of IOL. This data will be taken in concern for the validity of this study.

Eligibility Criteria:
Inclusion Criteria:

* retrospective: Patients who have undergone a Cataract surgery with Implantation of IOL L313
* prospective: signed informed consent

Exclusion Criteria:

* capsule rupture
* patients with too much travel distance between study center and home
Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 26-28 weeks of gestation.
* Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan

Exclusion Criteria:

* Multiple pregnancies.
* Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour rupture of the membranes (PPROM).
* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent -intervention and delivery.
* Women who have been maintained on progestin therapy since early pregnancy for whatever reason.
Nasal Steam Therapy for Post-extubation Respiratory Events

The effect of symptom improvement of nasal steam strategy compared to routine management strategy for upper respiratory symptoms occurring after endotracheal intubation in patients aged 19 years or older who underwent surgical removal under anesthesia requiring endotracheal intubation was evaluated by the difference in the results of Wisconsin Upper Respiratory Symptom Survey

This study aims to confirm the comparative effectiveness of nasal steam therapy by conducting a practical randomized controlled clinical trial comparing 66 patients complaining of upper respiratory symptoms with patients treated with a nasal steam therapy strategy (33 patients) and patients treated with a routine management strategy (33 patients).

This study is a practical clinical study, and only randomly assigns patients to two groups: nasal steam therapy strategy and routine management strategy. The specific treatment method used is not determined in advance. The specific treatment is performed according to the clinical judgment according to the patient's condition. All treatment methods used during the study are recorded in the case report and compared.

The treatment will be administered for a total of 5 days, and drug treatment may not be discontinued after the study period at the clinician's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Age of 19 to 69 years

  * Those who underwent surgical removal of the thyroid gland under endotracheal intubation due to a thyroid tumor

    * American Society of Anesthesiologists (ASA) status I or II

      * Those who developed upper respiratory symptoms after surgery ⑤ Voluntarily decided to participate in this clinical trial and signed the informed consent form

Exclusion criteria:

* Those diagnosed with symptomatic gastroesophageal reflux disease

  * Chronic cough lasting for more than 3 months prior to surgery, including bronchial asthma and chronic obstructive pulmonary disease (COPD)

    * Those who developed other respiratory infections within the past month ④ Those who are taking or are required to take other medications that may interfere with the interpretation of the treatment effect or results

      * Those who are scheduled to undergo additional major treatments such as reoperation, chemotherapy, and radiotherapy during the clinical trial period ⑥ Pregnant women, breastfeeding women, and those who plan to become pregnant during the study period ⑦ Others who are expected to have difficulty complying with the treatment, visits, and questionnaires stipulated in this protocol at the discretion of the medical staff