cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures

In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches.

The specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have an unstable DRF for which surgical fixation is indicated

  o AO type A2, A3, C1, C2
* At least one of the following radiographic criteria indicating fracture instability

  * Dorsal angulation of greater than 10°
  * Radial inclination angle of less than 15°
  * Radial shortening of greater than 3mm
* Patients with the ability to read and understand English (to complete study questionnaires)
* Community-dwelling patients
* Patients 60 years of age or older

Exclusion Criteria:

* Patients who have suffered open DRFs
* Patients with bilateral DRFs
* Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation
* Multi-trauma patients
* Patients with prior DRF on the same wrist
* Patients with comorbid conditions prohibiting surgery
* Patients with neurologic disorders that affect hand, wrist or arm sensation or movement
* Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders
* Patients with current substance abuse
* Patients who do not agree to be randomized
* Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)
Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors

The purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy American control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.


Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese (BMI ≥25, ≤40 kg/m2)
* Moderately elevated LDL-C between the 25-95th percentile from NHANES:

105-194 mg/dL for males; 98-190 mg/dL for females.

Exclusion Criteria:

* Tobacco use
* Systolic blood pressure ≥159 mm Hg
* Diastolic blood pressure ≥ 99 mm Hg
* A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds)
* Blood pressure or cholesterol-lowering medication use
* Refusal to discontinue intake of putative cholesterol-lowering supplements (e.g. psyllium, fish oil, soy lecithin, niacin, fiber, flax, stanols/sterols)
* Vegetarianism or dietary practices that are inconsistent with the test diets
* Nut allergies
* Refusal to discontinue nutritional supplements, herbs, or vitamins
* History of inflammatory gastrointestinal disease
A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5 mg Mavacamten in Healthy Participants

The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a body mass index between 18 and 32 kg/m2.
* Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
* Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

* Participants must not have any significant acute or chronic medical illness.
* Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
* Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.

Other protocol-defined inclusion/exclusion criteria apply
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

PRIMARY OBJECTIVES:

I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.

II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.

III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

Participants in all arms participate in discussions throughout the trial.

SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.

Eligibility Criteria:
Inclusion Criteria:

* \>= 21 years old
* Smoke \>= 5 cigarettes per day for the past year
* Willing to use either an EC or NRT
* Read and speak English
* Have a smartphone

Exclusion Criteria:

* Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
* Current use of an EC \> 4 days a month
* Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
* Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
* History of cardiac event or distress within the past 3 months
* Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
* High blood pressure not controlled by medications
* Serious angina pectoris or chest pain
* Stroke within the past three months
* Known allergy to propylene glycol or vegetable glycerin
* Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
* Live in same household as another study participant
The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke

Supine positioning was reported to increase upper airway collapsibility, apnea frequency and duration. Positional therapy, designed to minimize supine sleep, was reported to be beneficial in the general sleep apnea population. As supine sleep is very common in stroke patients, positional therapy might also have therapeutic effects. Given differences between stroke patients with sleep apnea and the general sleep apnea patient, such as rolling ability, body mass index and daytime sleepiness, positional therapy results in the general population may not be applicable to the stroke patient.

The effects of positional therapy in ischemic stroke patients with OSA have not been well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The tolerability of positional therapy over a 3-month period in patients with ischemic stroke was also evaluated.

Phase 1:

In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was used with no washout period. After an acclimatization period (3 days), during which the compliance of the Positional Device was monitored, each patient was randomized into either Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome measures were repeated on the last day of each treatment period. On the control night (B), subjects used the lumbar corset and were positioned ad lib.

Phase 2:

In the second phase of the study which began immediately after attainment of the first phase, subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression scale. Subjects in the positional devices group were also evaluated about devices adherence using the following questions: use of the device all nights, most nights, some nights, or no nights.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke (\> 1month, within 12 months) and moderate-to-severe OSA (AHI\>15) who could wear the positional devices not interfering with his/her sleep.

Exclusion Criteria:

* unclear consciousness
* unstable vital sign or neurologic sign
* unstable medical conditions
The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.


Eligibility Criteria:
Inclusion Criteria:

-Exposure group:

Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time:

1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles);
2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique.

   * Non-exposed group:

Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers.

Exclusion Criteria:

* Unwilling to participate in this research;
* Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up;
* Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations;
* Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;
Neurofibromatosis Type 1 Patient Registry

The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based registry that asks participants to fill out a 30-minute online questionnaire to collect information about the spectrum of medical and social problems experienced by children and adults with NF1. The information gained from your participation may one day help doctors develop personalized treatments for individuals living with NF1.

We are currently enrolling individuals with NF1 who either (1) HAVE previously been diagnosed with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor. Please note: there is no therapy associated with this study. Individuals may participate in the registry by going to https://nf1registry.wustl.edu/


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed by a healthcare provider with Neurofibromatosis Type 1

Exclusion Criteria:

* Individuals without a healthcare provider diagnosis of Neurofibromatosis Type 1
Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) \<50,000 copies/mL
* Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a \<13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1)
* Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1)
* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last dose of the study vaccine.

Exclusion Criteria:

* History of World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months
* History of invasive pneumococcal disease
* Known hypersensitivity to any vaccine component
* Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease
* Bleeding disorder contraindicating intramuscular vaccinations
* History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Female participant: positive urine or serum pregnancy test
* Expect to receive any pneumococcal vaccine during the study outside of the protocol
* Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* Received a blood transfusion or blood products within 6 months of enrollment
* Participated in another clinical study of an investigational product within 2 months of enrollment
* Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence
HER2-positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma in Russia

This study is a multicenter non-interventional observational retrospective study with secondary data collection

It will be multicenter study. Planned number of study sites is about 50 oncological centers specialized on anticancer chemotherapy in various regions of Russia. A multi-center collaborative effort will help to describe characteristics of patients with HER2-positive gastric and/or GEJ adenocarcinoma in different regions in the most comprehensive way and to capture more patients into database, not only limited to a single institution

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced/metastatic gastric and/or gastroesophageal junction (GEJ) adenocarcinoma, with the diagnosis established between the 1st January 2022 and the 1st January 2023.
* Patients with documented HER2+ status based on IHC score ± ISH status.
* Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status by the reference laboratory.
* Age ≥ 18 years at the time of inclusion.
* Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted.

Exclusion Criteria:

* Patients receiving trastuzumab deruxtecan currently or in the anamnesis.
* The participation in any randomized controlled trial within period since diagnosis (between the 1st January 2022 and the 1st January 2023) until the timepoint of data collection
Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer

Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.


Eligibility Criteria:
Inclusion Criteria:

1. Small cell lung cancer patients.
2. The clinical stage at baseline is extensive.
3. A measurable lesion.
4. Disease progression.
5. ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
6. Adequate laboratory indicators.
7. No pregnant or breastfeeding women, and a negative pregnancy test.
8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Has used topotecan and anlotinib hydrochloride capsules.
2. Has used other anti-angiogenic drugs and immunologically targeted drugs.
3. Has other malignant tumors within 5 years.
4. Symptomatic brain metastasis.
5. Has a variety of factors affecting oral medications.
6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
7. Spinal cord compression.
8. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
9. Adverse events caused by previous treatment did not recover to grade 1.
10. Has received major surgical treatment within 4 weeks before randomization.
11. Arteriovenous thrombosis occurred within 6 months.
12. Has drug abuse history that unable to abstain from or mental disorders.
13. Has severe or uncontrolled disease.
14. Participated in other clinical trials within 4 weeks.
15. Tumor invades the large blood vessels.
16. Daily hemoptysis ≥2.5 mL within 1 month before the first dose.
17. According to the investigators' judgement.
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Investigator diagnosis of breast cancer
* Age 18 to 70 years
* ECOG performance status ≤ 1
* Chemotherapy naïve
* Body weight ≥ 45kg
* Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

Exclusion Criteria:

* Prior bone marrow or stem cell transplantation
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Radiation therapy within 4 weeks of randomization into this study
* Pregnancy, lactation