cyrilzakka/clinical-trials huggingface dataset:
Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion

Locked posterior glenohumeral dislocations with a reverse Hill-Sachs impaction fracture involving less than 30% of the humeral head are most frequently treated with lesser tuberosity transfer into the defect, whereas those involving more than 50% undergo humeral head arthroplasty. Reconstruction of the defect with segmental femoral osteochondral allografts has been proposed to treat patients between these two ranges, but the medium-/long-term outcomes of this joint-preserving procedure are controversial.

Twelve patients with a unilateral locked posterior shoulder dislocation and at least 30% (mean 31%) impaction of the humeral head were treated with segmental reconstruction of the defect with fresh-frozen humeral head osteochondral allografts. Patients were assessed clinically, radiographically and with computed tomography (CT) at a medium follow-up of 66 months (range, 24-225).All twelve shoulders presented a slight limitation in anterior elevation

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of an acute non-reducible posterior gleno-humeral dislocation with an associated McLaughlin lesion affecting more than 30% of the cartilaginous circumference of the humeral head.

Exclusion Criteria:

- Patients with associated injuries to the affected upper limb, with neuromuscular or psychomotor disorders or with disorders affecting connective tissues.
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \>= 5,000-30,000 HIV-1 RNA, 2) \> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[RTIs\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 \> 100 cells/mm3.
* Saquinavir HGC-experienced patients (\>= 3 months cumulative therapy).

Required:

\>= 3 months cumulative saquinavir HGC therapy.
Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis with gastric or gastroesophageal cancer
* Karnofsky performance status score of at least 70
* Life expectancy of at least 3 months

Exclusion criteria:

* Prior treatment with chemotherapy or anticancer immunotherapy
* Bone marrow transplant within past year
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Central nervous system metastases
* Immunodeficiency
* Hypercalcemia
A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline

Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality for various settings of management in radiation oncology. For example, the indications for WBRT should include brain metastasis or metastases, the setting of prophylactic cranial irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are essentially based on that it can target both microscopic and gross intracranial disease.

In addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial disease control, WBRT might also prolong the time to develop neurocognitive function (NCF) decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline occurs within the first 1 - 4 months after WBRT for brain metastases. The domains of early neurocognitive decline principally involve verbal and short-term memory recall.

Since several decades ago, it has been understood that hippocampus plays an essential role in memory function. Not little evidence supports that radiation-induced damage to hippocampus should be strongly associated with NCF impairment. Furthermore, several studies have shown that isodose distribution in hippocampus is closely related to neurocognitive function in patients with benign or low-grade brain tumors. As a consequence, it is hypothesized that conformal hippocampal sparing during the course of WBRT (HS-WBRT) might provide significant preservation in terms of cognitive function.

This prospective cohort study aims to explore and evaluate the impact of the delivery of HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it will also be investigated whether neurocognitive functional preservation can be achieved via the integration of hippocampal sparing with the course of WBRT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically-confirmed non-hematopoietic malignancy who are referred for therapeutic or prophylactic WBRT
* Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %
* The number and extent of brain metastatic lesions should be no more than three metastatic foci with a greatest diameter no more than 4 cm

Exclusion Criteria:

* Patients with MRI-identified metastasis within 5 mm perihippocampally
* Clinical suspicion of leptomeningeal spreading
* History of prior radiotherapy including stereotactic radiosurgery delivered to brain/head region for any reasons
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin

Light-emitting diode (LED) light therapy is increasingly used successfully and without adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to perform a study in subjects with a sensitive skin without associated dermatosis.

The objective of the study is to evaluate the efficacy of light-emitting diode therapy in subjects with sensitive skin and to assess pain improvement, evaluation of improvement in pruritus and evaluation of treatment tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Age less than or equal to 70
* Sensitive skin defined by a score ≥ 40 on the Sensiscale scale
* Patient able to consent

Exclusion Criteria:

* Persons under 18 years of age or over.
* Persons suffering from disorders of higher functions preventing comprehension of the questionnaire.
* Pregnancy.
* Analgesic or medication acting on the nervous system.
* Other dermatosis of the face (example: rosacea, seborrheic dermatitis, acne ...).
* Neurological or psychiatric illness.
* A photosensitizing drug.
* Refusal of patient
* Patients under legal protection
Weightbearing Assessment of Tarsal Instability

The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.


Eligibility Criteria:
Symptomatic group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD

Exclusion Criteria:

1. previous surgery
2. infection
3. tumor in the affected foot
4. pregnancy

Control group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) without foot deformity

Exclusion Criteria:

1. history of previous foot and ankle surgery
2. foot deformity
3. known foot and ankle pathology
4. pregnancy
Proton Therapy for Early Stage Breast Cancer

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Invasive ductal, medullary, papillary, colloid or tubular histologies
* Stages T1 or T2 (tumors \< or = 3 cm) from lumpectomy specimen.
* No more then 3 positive nodes on axillary dissection or negative sentinel node.
* Negative surgical margins (\>2mm)

Exclusion Criteria:

* Invasive lobular histology
* Previous chemotherapy for breast cancer
* Extensive intraductal component
* Collagen vascular disease
* Prior malignancy unless disease-free for 5 years
* Patients who are pregnant or lactating
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.

Objectives:

1. To examine whether patients with delirium have higher prevalence of cytochrome-P450 abnormalities compared to patients without delirium.
2. To examine whether the severity of delirium is related to a specific cytochrome P450 genotype.
3. To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome p450 abnormalities
4. To examine whether delirium persistence is impacted by types of medications administered during their hospital stay.

Delirium is a costly and devastating illness affecting older patients in the hospital. Its prevalence increases as patients get older and sicker. There is scientific evidence that delirium affects cognitive function for a prolonged period of time and in many cases irreversibly. The economic burden on health care and emotional burden on the caregivers of patients with delirium is tremendous. We think that our study may contribute to developing prevention strategies for delirium in the hospital. We propose genetic testing of older patients to determine their ability to metabolize commonly used medications in the hospital. This will give medical professionals and pharmacists an ability to adjust dosages of medications based on the patient's genetic profile.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 and older admitted to the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
2. One or more of the Following Principle Diagnosis:

   Principle stroke diagnosis Principle Cardiac-Post cardiac surgery Principle Spinal surgery
3. Non-English speakers are not anticipated. However, there is an available interpreter services already on the unit and this interpreter's services will be utilized. https://www.languageline.com/ However, we will utilize that AHC IRB approved short forms if a potential subject presents itself.

Exclusion Criteria:

1. Stroke patients with any diagnosed aphasia
2. Spinal surgery, as a result of trauma
3. Pregnant women
4. Prisoners
5. Patients with dementia (score of greater than 3.3 on short IQCODE questionnaire) (Long Term Cognitive Impairment after Critical Illness, NEJM, 2013, Pandharipande et al.)
6. Patients with cirrhosis and liver failure
7. Patients with renal failure requiring dialysis
8. Recent blood transfusion
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.

MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster) drug eluting stent (test) and Kaname bare metal stent (comparator).

Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3 years.

500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio, to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in Kaname arm)

Eligibility Criteria:
Inclusion Criteria:

* Age equal or more than 18 years
* Chest pain \> 20 minutes
* Primary PCI \<24h from symptoms onset
* ST-segment elevation of \> 1 mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \> 1 mm in \> 2 contiguous anterior leads
* Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.5-4.0 mm in diameter that can be covered with one or multiple stents
* Signed informed consent

Exclusion Criteria:

* Female of childbearing potential (age \< 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
* Known intolerance to aspirin, clopidogrel, heparin, bivalirudin, cobalt, chromium, nickel, sirolimus or contrast material
* Currently participating in another trial before reaching primary endpoint
* Mechanical complication of acute myocardial infarction (e.g. cardiogenic shock...)
* Acute myocardial infarction secondary to stent thrombosis
* Previously stented infarction related artery (IRA)
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
* Patients with non-cardiac comorbid conditions with life expectancy\< 1 year or that may result in protocol non-compliance
* History of bleeding diathesis or known coagulopathy
* Use of oral anticoagulants
The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments

Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.

Sodium hypochlorite (NaOCl) is a gold standard irrigation solution that has antimicrobial and tissue solvent effect. Until now, there is no other alternative that provides its activity characteristics. Although it represents many advantages, and it is usually considered safe, some cases of mishap and systematic reviews about case reports of NaOCl accident especially during endodontic procedures, have been reported in the literature. NaOCl may lead potentially very damaging injuring results with acute pain, swelling, hemolysis, ulceration, inhibition of neutrophil migration, endothelial and fibroblast cell damage, nerve weakness or damage, trismus and tissue necrosis if it overflows the periapical area.

The aim of this prospective observational investigation is to determinate the frequency of the extrusion in endodontically treated teeth.

The patients who applied to the clinic for dental treatment will be identified as having root canal treatment indication for at least one tooth. After the detailed medical and dental history will be obtained, the written consent form was taken from the patients who wanted to participate in the study. Age, gender, medical history, preoperative pain and pulpal status, having any periapical radiolusency of the related tooth will be recorded and root canal treatment will be performed according to routine procedures. After treatment, the code of tooth according to FDI classification, number of root, apical diameter, volume and concentration of irrigation solution will be recorded.

Routine treatment follow-up will be performed in patients who has no NaOCl overflow from the root during procedure. The patients with NaOCl overflow during the treatment process, appropriate treatment will be planned and followed up until symptoms regress.

Eligibility Criteria:
Inclusion Criteria:

* Requirement of root canal treatment

Exclusion Criteria:

* Sodium hypochlorite allergy
* Immature tooth
* root resorption
Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery

the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment.

The main objective was to collect patients with fleae or seborrheic keratosis after Q-switched laser treatment, and then to use exosomes or matrix on both sides of the face, and finally to evaluate the effect of exosomes on wound healing and prevention of post-inflammatory hyperpigmentation after Nd:YAG laser 532 treatment

Eligibility Criteria:
Inclusion Criteria:

* It meets the diagnostic criteria of seborrheic keratosis or freckle；
* pepole are able to follow the treatment rules of the study and were followed up for 8 weeks；
* informed consent

Exclusion Criteria:

* History of keloids ;
* Pregnancy or lactation;
* Any cosmetics containing growth factor-related ingredients used within 6 months prior to treatment
* Patients with incomplete observation data and incomplete course of treatment were excluded
Autogenous Ramus Bone Block Harvesting With Piezosurgery

The aim of this randomized prospective clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the Conventional and Piezosurgery Method.

The study was planned on 19 patients (13F,6M) on 31 donor sites. In patients with bilateral bone harvesting, the donor site and the surgical method to be used were determined by the randomization protocol, while in patients with bone harvesting from a single site, the donor site was determined by considering parameters such as proximity to the operation site and distance to the inferior alveolar nerve. Clinical parameters such as operation time, pain, swelling, trismus, nerve damage were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* The main inclusion criteria were severe alveolar ridge atrophy in the horizontal plane (≤4 mm) and no accompanying vertical defect, according to preoperative CBCT scans.

Exclusion Criteria:

* Individuals who had systemic disease affecting bone or soft tissue metabolism
* Smokers (more than 10 cigarettes a day
* Alcohol dependent
* Systemic disease affecting bone or soft tissue metabolism
* Donor field in the mouth of another region (simfiz, tuber etc.) or any extra-oral field is planned to be used
* Patients with cleft lip-palate or defect exceeding the alveolar crest
* Grafts applied to defects caused by tumors, osteoradionecrosis, or congenital malformations
* Patients with an unstable systemic condition such as metabolic bone disease, uncontrolled diabetes, or untreated hypothyroidism, as well as smokers, patients undergoing radiation therapy or chemotherapy
A Phase I Clinical Study to Evaluate the Effect of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight/Obese Subjects

This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of multiple subcutaneous injections of GZR18 Injection on the pharmacokinetics of multiple oral doses of metformin hydrochloride tablets.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive subcutaneous injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.
* Male or female, 18 to 50 years of age at signing the ICF (both inclusive).
* Weight ≥ 50 kg and body mass index (BMI) within 24-33 kg/m2 (both ends inclusive) at screening.
* Subjects of childbearing potential with no birth plan from the signing of ICF to 3 months after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (prior to enrollment).

Exclusion Criteria:

* Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disease, malignant tumor and other diseases that are judged by the investigator to have an impact on pharmacokinetics and safety evaluation.
* History or existing diseases that increase the risk of subjects, such as hypoglycaemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of acute biliary pancreatitis at screening (e.g., silt-like lithiasis, gallbladder ≤ 5 mm in diameter and bile duct stone, etc.).
* Subjects with previous or existing diseases that significantly affect drug absorption, metabolism or excretion, such as history of active peptic ulcer or haemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), long-term use (continuous for ≥ 1 week) of drugs that affect gastrointestinal motility (including but not limited to domperidone, mosapride, macrolides).
* Subjects with severe infection or unexplained infection within 4 weeks before screening.
* Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.
* History of drug abuse prior to screening; or positive results for drug abuse at screening.
* Subjects who used nicotine-containing products within 3 months prior to screening or are screened positive for nicotine in urine.
* Other factors that make subjects unqualified to participate in this trial as judged by the Investigator.