cyrilzakka/clinical-trials huggingface dataset:
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies \[ADAs\]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.


Eligibility Criteria:
Inclusion Criteria:

* The participant completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to participant safety and participant compliance.
* Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
* In addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)

  * Additional criteria apply, please contact the investigator for more information
Treatment of Complex Pilon Fractures

This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.


Eligibility Criteria:
Inclusion Criteria: Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital.

Exclusion Criteria: Anyone under the age of 18 years. Pregnant women.
Geriatric Polytrauma SOP

This study investigated whether there were improvements in the in-hospital mortality, infection rate, and rate of palliative care among geriatric trauma patients after the implementation of new standard operating procedures (SOPs) for the resuscitation room. These new SOPs, comprising early whole-body computed tomography (CT), damage control surgery, and the use of goal-directed coagulation management, were designed for severely injured adult trauma patients

This study involved the analysis of a prospective single-centre database. Patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included and compared before the implementation of the new SOPs (between 1 January, 2000 and 31 December, 2006) and after their implementation in 2009 (between 1 January, 2010 and 31 December, 2012) of our level-I trauma centre.

Eligibility Criteria:
Inclusion Criteria:

Inclusion in internal trauma database

Exclusion Criteria:

Comprised age \< 65 years, ISS \< 9, and transfers from other hospitals.
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.


Eligibility Criteria:
Key Inclusion Criteria:

* Not a candidate for fludarabine therapy based on either:

  1. creatinine clearance \< 70 mL/min, or
  2. Cumulative Illness Rating Scale score \> 6, by assessment of the investigator
* Diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
* No prior therapy for CLL other than corticosteroids for disease complications.
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

* Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Concurrent participation in another therapeutic clinical trial
* Undergone major surgery within 30 days prior to randomization
* Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil
* History of non-infectious pneumonitis
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia

The relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process.

Pudendal neuralgia is a syndrome that is characterized by pelvic pain, including bowel, bladder regional pain or discomfort, sexual dysfunction, severe burning sensations and needle-like pain, which are aggravated when seated and relieved after standing. pudendal neuralgias are induced by pudendal nerve damage The mechanism of PRF has been studied repeatedly. It has been verified that PRF has definite safe treatment range, but during the PRF treatment, the tissue surrounding the electrode may have some degree of change and so it is difficult to assess any actual damage.7 Based on electric field intensity, PRF can actually produce tissue changes observable as in vitro changes to ultrastructure in early-phase histologic study. These biological changes were converted to biological effect to alleviate neuropathic pain in animal models.


Eligibility Criteria:
Inclusion Criteria:

* pain located in the pudendal nerve distribution area
* pain intensity increases in the sitting position;
* no nocturnal pain symptoms;
* pain with no objective sensory impairment
* pain is relieved by diagnostic pudendal
* the pain symptom is associated with sexual dysfunction, with the elimination of obstetrical and gynaecologic, urological and anorectal diseases in the related departments and absence of any physical and mental disorders;
* treatment by other departments is invalid;
* patients should be older than 18 years
* patients should be able to sign an informed consent form

Exclusion Criteria:

* patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or have imaging anomalies that may explain the symptoms;
* female patients who are pregnant;
* patients who take anticoagulant drugs or have any coagulation disorder;
* patients who are unable to complete the questionnaire;
* patients with pain, which is caused by malignant or autoimmune diseases and
* patients who are hypersensitive to metals.
Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome

The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have different levels of certain chemicals in their blood than people who don't have POTS. This study will test whether the blood vessels of people with POTS will react differently to certain tests than people without POTS.

The hypothesis of the study is:

Patients with POTS will have vascular endothelial dysfunction compared with control subjects.


Eligibility Criteria:
Inclusion Criteria:

ALL:

* Ages between 18-60 years old
* Male and female subjects are eligible
* Able and willing to give informed consent

Additional criteria for POTS:

* Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic - Dysfunction Center (1. increase in heart rate \>/= 30 beats/minute with position change from supine to standing for 10 minutes and/or 2. Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence.

Additional criteria for Control subjects:

* Healthy, non-obese, non-smokers without orthostatic tachycardia
* Selected to match profiles of POTS patients (gender, age)
* Not using vasoactive medications

Exclusion Criteria:

* Overt cause for postural tachycardia (such as acute dehydration)
* Inability to give, or withdraw informed consent
* Pregnancy
* Other factors in the investigator's opinion would prevent the subject from completing the study
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+, 2+ and FISH-), especially Clinical outcomes of endocrine therapy for metastatic breast cancer with low HER2 expression (HER2 1+, 2+ and FISH-), exploring potential biomarkers of CDK4/6 inhibitors, and understanding the outcome characteristics of HER2 heterogeneity in MBC through multivariate analysis , and guide clinical application.


Eligibility Criteria:
Inclusion Criteria:

* 1) Female patients with advanced breast cancer aged ≥18 years. 2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions.

  1. ER positivity and/or PR positivity is defined as: the proportion of tumor cells with positive staining accounts for ≥ 10% of all tumor cells (confirmed by the investigator of the trial center);
  2. HER2 negative is defined as: standard immunohistochemistry (IHC) test is 0/1+; HER2 (2+) needs to be tested by FISH, HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4 (by the test center of the test center) Investigator review and confirmation).

     3) CDK4/6 inhibitors combined with endocrine therapy can conduct complete efficacy evaluation and follow-up information collection.

     4) Postmenopausal or premenopausal/perimenopausal female patients can be enrolled.

     Postmenopausal status, defined as meeting at least one of the following criteria: prior bilateral ovarian surgery; age ≥60 years; age \<60 years, menopause for at least 12 months (not due to chemotherapy, tamoxifen, toremide) fen or ovarian suppression) and follicle-stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.

     Premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRHa during the study period.

     5) According to RECIST 1.1 criteria, patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions.

     Exclusion Criteria:
* 1) Early breast cancer patients receive CDK4/6 inhibitor drug therapy. 2) HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or positive fluorescence in situ hybridization.

  3) Pregnant or lactating female patients. 4) Patients deemed unsuitable for inclusion by the investigator.
Alpha1-antitrypsin Deficiency Registry

To collect data from the 37 participating clinical centers on patients with alpha1-antitrypsin deficiency, including those who received replacement therapy with an intravenous preparation of alpha1-proteinase inhibitor (A1Pi) concentrate.

BACKGROUND:

Severe congenital deficiency for alpha1-antitrypsin is associated with the early onset of emphysema, usually by the third decade of life. One approach to correct this deficiency is though replacement with alpha1-antitrypsin (referred to as alpha1-proteinase (A1Pi) inhibitor in its purified form). An intravenous preparation of A1Pi concentrate was produced from human plasma by Cutter Biological, a division of Miles, Inc., Berkeley, California. This preparation had been evaluated in a clinical study for its safety and biochemical efficacy. Based on the augmentation of its levels in the lung upon intravenous administration, the A1Pi preparation was licensed by the Food and Drug Administration for replacement therapy to treat individuals with severe congenital deficiency and impaired lung function. When the registry began in 1988, clinical efficacy was plausible, but unproven and there was no data base for estimating the degree of clinical benefit, if any.

Slow progression of emphysema and lack of an adequate control group have made it difficult to evaluate the proteinase inhibitor through a controlled clinical trial. A patient registry was an alternative method to collect data on the effect of long-term replacement therapy with A1Pi on rate of decline of lung function. The registry also included individuals who did not receive the replacement therapy in order to obtain a better knowledge of the rate of decline of lung function associated with the congenital deficiency for alpha1-antitrypsin.

DESIGN NARRATIVE:

The registry consisted of a clinical coordinating center, 37 participating clinical centers that contributed patient data to the registry, a steering committee, and a data analysis and policy board, both appointed by the National Heart, Lung, and Blood Institute. Data collected on all patients included a clinical history, laboratory evaluations such as chest x-ray, lung function studies of vital capacity, total lung capacity, forced expiratory volume in one second (FEV1) and blood studies. In addition, patients receiving replacement therapy had baseline lung function tests, spirometry every six months following initiation of replacement therapy, and measurements of serum alpha1-antitrypsin level pre- and post-infusion, once every six months. The recruitment phase ended in September 1990. Support for the registry ended in June, 1998.

Eligibility Criteria:
No eligibility criteria
A Randomized Controlled Study of Enteral Nutrition in Septic Shock

There is a paucity of data on the timing and role of enteral nutrition in septic shock.

The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.

Septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure \< 70 mmHg) despite intravenous (IV) fluid resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year In critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. These benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data addressing this question are lacking.

The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic shock patients to determine feasibility of achieving \>75% consent and compliance rate and \<10% contamination rate.

Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to 18 years old
* Clinical diagnosis of septic shock
* Mechanically ventilation anticipated for at least 48 hours

Exclusion Criteria:

* Do not resuscitate order
* Not able to obtain consent
* Those not able to be randomized within 18 hours
* Those with small bowel ischemia or obstruction
* Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
* Those with a contraindication for placement of a feeding tube
Correlation Between Estimated Glomerular Filtration Rate(eGFR) and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and cardiovascular mortality.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between eGFR and vascular inflammation detected by 18F FDG-PET.


Eligibility Criteria:
Inclusion Criteria:

1. absence of prior cancer diagnosis or remission from cancer at the time of PET imaging and throughout the follow-up period;
2. \>=30 years of age;
3. no prior history of cardiovascular disease ; and
4. absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy.

Exclusion Criteria:

1. age \<35 years
2. presence of chronic inflammatory disease
3. use of anti-inflammatory medications
4. presence of active malignant cancer (defined as any radiological or pathological evidence of malignant cancer disease or undergoing chemotherapy or radiation therapy within 1 year before initial PET/CT and throughout the inter-scan duration).
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.

Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.

Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Fully lactating mothers age 18 and up
* Within 1 month after delivery
* Plan to breast feed for at least 6 months

Exclusion Criteria:

* Known metabolic bone disease
* Chronic renal insufficiency
* Chronic corticosteroid use
* Eating disorder
* Estrogen containing hormonal contraception use
* Daily use of \>400IU Vitamin D supplementation
* Delivery of Multiples
* Delivery of a singleton with a birth weight of \<2500 grams
* Preterm delivery of baby
* History of kidney stones
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.

The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subject 18 years of age or older
* Gastric bypass operated or similar
* Excess abdominal skin to be removed surgically
* Abdominal skin tone 4 or below

Exclusion Criteria:

* Extensive skin changes, tattoos or diseases on skin explant to be donated
* Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.