cyrilzakka/clinical-trials huggingface dataset:
Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the posterior ring might result in a fatal course. Different types of external emergency stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has not been investigated yet.

Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially for the posterior pelvic ring. However, whether these disadvantages make up for a more efficient bleeding control, still needs to be discussed in the guidelines of the emergency management of pelvic ring fractures.

Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp. The patients were matched according to the following parameters: age, gender, initial RR and HB level. The complication rates and mortality rates were compared between the groups, especially regarding bleeding control, as measured by the amount of transfused blood products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the time until established bleeding control was compared.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for data acquisition in the German Pelvic Registry
* Pelvic ring fracture Type C (AO/OTA)
* ISS (Abdomen) \>8

Exclusion Criteria:

* Acetabular fracture
* Pelvic ring fracture Type A/B (AO/OTA)
* ISS (Abdomen) \<9
Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias

This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male / female adult, 30 years old or more;
2. Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
3. Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
4. Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:

   1. with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
   2. with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).

Exclusion Criteria:

1. Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
2. Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
3. Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
4. Subject Who had undergone or who was scheduled for functional neurosurgery for Parkinson's disease during the trial period;
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma


Eligibility Criteria:
INCLUSION:

* Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma \& transformed lymphoma.)
* No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks.
* Not be eligible for treatment of a higher priority.
* Performance status \<2 Zubrod, \> 60 Karnofsky.
* Good marrow reserve: ANC\>1.5 x 10(9)/L, platelets \> 100 x 10(9)/L.
* Bilirubin \<1.5mg/dL, SGOT, SGPT \< 2 x normal values.
* Serum creatinine \< 1.8 mg/dL.
* Age \> 18 yrs.
* Signed informed consent.
* Life expectancy of \> 12 weeks.
* No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.
* No prior stem cell or bone marrow transplantation.
* No prior second malignancies except for basal cell carcinoma of the skin.

EXCLUSION:

* Active or prior history of CNS lymphoma.
* Serious intercurrent medical illnesses requiring hospitalization.
* History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids).
* Prior exposure to Filgrastim-SD/01.
* Women who are pregnant or lactating.
* Participation in another clinical trial.
* Positive HIV antibody.
* History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).
A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy

Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to give an informed consent for the study.
* Males or females aged 18 to 80 years.
* Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 1.
* Pathologically (histologically or cytologically) confirmed, non-metastatic diagnosis of squamous cell carcinoma of head and neck (SCCHN).
* Achievement of major pathological reaponse (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy.
* Adequate bone marrow, liver, and renal function:

Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 9.0g/dL, platelets ≥100000/μL; ALT and AST \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN； Creatinine clearance ≥ 60 ml/min； APTT≤ 1.5×ULN.

Exclusion Criteria:

* Participant has metastatic/unresectable SCCHN.
* Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
* With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
* With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
* With active infection requiring systemic therapy.
* Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
* Any other factors that are not suitable for inclusion in this study judged by investigators.
The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE

Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with active EoE (naïve and experienced)
* Ages 1-18 years

Exclusion Criteria:

* Change in dosing of Proton pump inhibitors (PPI) medication
* Local steroid treatment \< 1 month
* Refusal to comply with study protocol
* Known allergy to almonds and buckwheat
* Use of dairy during the study
Face Masks to Reduce SARS-CoV-2 Infections (COVID-19) in Bangladesh

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. The study also examines if community-based activation through values or individual activation through information results in higher mask-wearing.

Detailed Description:

This study intends to answer the following research questions:

Can mask distribution and mask promotion at homes, mosques, markets and other public areas successfully change community mask-wearing norms to increase mask-wearing, even years into a pandemic?

Can community mask-wearing reduce SARS-CoV-2 infections (both symptomatic and asymptomatic)?

Is increased prevalence of community-level mask-wearing associated with decreased physical distancing?

To answer these questions, the investigators will conduct a cluster randomized trial which randomizes the proposed intervention at the village level in Bangladesh. Control communities will receive no intervention and treatment communities will receive an extensive intervention combining several elements. Study staff will distribute free face masks through door-to-door visits and at markets and mosques. In some communities groups of people will be encouraged to wear masks by appealing to their shared values and in other communities individuals will be encouraged to wear masks by discussing the biological value of masks (cross-randomized among intervention communities). Mask promoters in the community and at markets in treated villages will remind people about the importance of wearing masks and distribute additional masks. Markets will have signs that masks need to be worn to enter the market. Religious leaders will encourage mask use at religious services. The project will enroll 1200 communities, stratified in geographically proximate groups of 10; half will be randomized to receive the intervention.

Communities will be surveilled through direct observation at 0, 2, and 4 weeks to assess mask-wearing. The investigators will assess symptomatic and asymptomatic SARS-CoV-2 by conducting household visits every 6-10 days to ask about symptoms of COVID-19 and collecting nasal swabs to test by PCR for the presence of SARS-CoV-2. End line is planned for 4 weeks after the intervention begins, but may be shifted according to seroprevalence trends.

Eligibility Criteria:
Inclusion Criteria:

* Live in selected village

Exclusion Criteria:

* None
Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy

All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes

Exclusion Criteria:

* various other types of retinal and choroidal disease;
* history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.
* with severe refractive medium opacity that could affect fundus examination.
Deep Learning Using Chest X-Rays to Identify High Risk Patients for Lung Cancer Screening CT

The goal of this clinical trial is to evaluate whether an AI tool that alerts providers to patients at high 6-year risk of lung cancer based on their chest x-ray images will improve lung cancer screening CT participation. The main question it aims to answer is: Does the AI tool improve lung cancer screening CT participation at 6 months after the baseline outpatient visit

The intervention is an alert to the provider to discuss lung cancer screening CT eligibility, for patients considered at high risk of lung cancer based on CXR-LC AI tool.

If there is a comparison group: Researchers will compare intervention and non-intervention arms to determine if lung cancer screen CT participation increases.


Eligibility Criteria:
Major Inclusion Criteria:

* Scheduled outpatient appointment with participating provider.
* 50- to 77-year-old who currently or formerly smoked, to include persons potentially eligible for lung screening based on Medicare guidelines.
* Recent (within 2 years) PA chest radiograph.

Exclusion Criteria:

• History or signs/symptoms of lung cancer. Recent (within 2 years) chest CT. Clinical indication for chest CT beyond lung cancer screening.
Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery

In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 year old or older,
* daily smoker
* inpatient post fracture operation,
* patient that have never received an orthopaedic related smoking cessation discussion

Exclusion Criteria:

* Younger than 18,
* patients unable to provide consent
* patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker
Gendered Misallocation of Labor: Evidence from Malawian Farmers

The investigators will conduct a cluster randomized controlled trial across districts in Malawi to evaluate the effect of providing free casual labor to pregnant farmers and female farmers on agricultural output, maternal and child health outcomes, child development, and social networks.

This will be a cluster randomized control trial (RCT), where 75 of the districts in which One Acre Fund (1AF) currently operates within in Malawi will be randomly selected for inclusion in this study. Of these 75 districts, 38 will be randomly selected to implement the intervention. The intervention constitutes a voucher offered to all female famers who are currently enrolled in the 1AF program who are pregnant and/or have a child ages 1 years and below that entitles the recipient to a set number of days of labor from casual workers employed by local 1AF offices. The remaining 37 districts will serve as the control group.

Data will be collected at baseline during the planting season and endline at the conclusion of the harvest season. Data collected will pertain to agricultural output, individual and household demographics, obstetric history and outcomes, mental health, maternal health, child health and development, and social networks.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at time of One Acre Fund program rollout
* Mother to at least one child aged below 1 years of age

Exclusion Criteria:

-None
Myocardial Infarction, COmbined-device, Recovery Enhancement Study

Unplanned readmissions after hospitalization for acute myocardial infarction (AMI) are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions (DHI) could be an effective tool in promoting self-management, adherence to guideline directed therapy, and cardiovascular risk reduction.

A DHI developed at Johns Hopkins-the Corrie Health Digital Platform-includes the first cardiology Apple CareKit smartphone application, paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure monitor. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes cardiac rehabilitation and outpatient follow-up appointments.

In this prospective study, STEMI or type 1 NSTEMI patients are being enrolled to use the Corrie Health Digital Platform beginning early during participants' hospital stay. Enrollment sites include Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Massachusetts General Hospital, and Reading Hospital. The primary objective is to compare time to first readmission within 30 days post-discharge among patients with the Corrie Health Digital Platform to patients in the historical standard of care comparison group.


Eligibility Criteria:
Corrie Health Digital Platform group

Inclusion Criteria:

* Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
* 18 years or older
* English-speaking
* Own any type of smartphone

Exclusion Criteria:

* Visual, hearing, or motor impairment which precludes the use of the intervention
* Inability to participate due to severity of illness (e.g., intubated and on sedation in the setting of cardiogenic shock). If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member returns at a later date to determine whether this status has changed.

Historical Standard of Care Comparison group

Inclusion Criteria:

* Admitted for acute myocardial infarction (STEMI or NSTEMI)
* 18 years or older
* English-speaking

Exclusion Criteria:

* None
Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)

This clinical trial studies the safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP.

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility Criteria:
Inclusion Criteria:

* Legal guardian(s) must provide informed consent prior to any study procedures
* Documented diagnosis of severe HPP as indicated by:

  * Total serum alkaline phosphatase at least 3 standard deviations (SD) below the mean for age
  * Plasma pyridoxal 5'-phosphate (PLP) at least 4 times the upper limit of normal
  * Radiographic evidence of HPP (hypophosphatasia), characterized by:

    * Flared and frayed metaphyses
    * Severe, generalized osteopenia
    * Widened growth plates
  * One or more HPP-related findings:

    * History or presence of:

      * Non-traumatic post-natal fracture
      * Delayed fracture healing
    * History of elevated serum calcium
    * Functional craniosynostosis with decreased head circumference growth
    * Nephrocalcinosis
    * Respiratory compromise
  * Rachitic chest deformity and/or vitamin B6 dependent seizures
  * Failure to thrive
* Onset of symptoms prior to 6 months of age
* Age ≤ 36 months
* Otherwise medically stable (patient may be on ventilatory support)
* Legal guardian(s) must be willing to comply with the study

Exclusion Criteria:

* History of sensitivity to any of the constituents of the study drug
* Current or prior clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, infectious, urologic, pulmonary, neurologic, dermatologic, renal condition and/or other major disease which, in the opinion of the investigator, precludes study participation
* Treatment with an investigational drug within 1 month prior to the start of study drug administration
* Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation)
* Low serum calcium, phosphate or 25(OH) vitamin D
* Current evidence of a treatable form of rickets
* Prior treatment with bisphosphonate
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)

The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck Darmstadt (Reference Euthyrox).


Eligibility Criteria:
Inclusion Criteria:

* Participants have a body weight within 45 to 75 kilogram (kg) for females and 55 to 85 kg for males and Body mass index (BMI) within the range 19.0 to 26.0 kilograms per meter square (kg/m\^2)
* Non-smoker for at least 3 months
* Contraceptive use by males or females will be consistent with any local regulations on contraception methods for those participating in clinical studies
* Capable of giving signed informed consent
* Total and free Thyroxine (T4), total and free Triiodothyronine (T3) and Thyroid-stimulating Hormone (TSH) must be within normal ranges at Screening
* Ability to understand the purposes and risks of the study
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with history or presence of tumors of the pituitary gland or hypothalamus, thyroid or adrenal gland dysfunction or cardiac disease
* Participants with a concurrent medical condition known to interfere with the absorption or metabolism of thyroid hormones
* History or presence of relevant liver diseases or hepatic dysfunction. Participants with gall bladder removal
* Participants taking medications known to affect thyroid hormone metabolism, for example, oral contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens, etcetera
* Use of any investigational device within 60 days prior to first dose administration
* Pregnant or breastfeeding a child
* Participant has smoked within the 3 months prior to Screening
* High fiber consumption within 24 hours before dosing in each period
* Participants with positive results from serology examination for Syphilis, Hepatitis B surface antigen, Hepatitis C Virus or Human Immunodeficiency Virus
* Participants with any clinically relevant abnormality in the safety laboratory parameters
* Participants with positive test for drugs of abuse (including alcohol) at Screening and on Day -1 of each period (urine)
* Other protocol defined exclusion criteria could apply