cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects 18 to \<65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX.
* Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing.
* Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration.

Exclusion Criteria:

* Presence of a bleeding disorder in addition to hemophilia A or B.
* Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids).
* History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.
Reducing Fall Risks for Adults With Obesity

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.

Obesity has a negative impact on aspects of walking associated with fall risks. After weight loss surgery, adults show improvements in walking. However, those who undergo surgery still show deficits in walking and an additional group of individuals do not undergo the procedure. Our objective was to examine if practice could improve gait patterns associated with fall risks before patients underwent weight loss surgery. Adults with obese body mass index between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery procedure walked under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables selected included velocity (cm/s), cadence (steps/minute), step length (distance between consecutive steps), step width (lateral distance between feet), single limb support time (amount of time spent on one leg during the walking cycle), and double limb support time (amount of time spend on two legs during the walking cycle).

Eligibility Criteria:
Inclusion Criteria:

* between 30 and 60 years old
* eligible to undergo Roux-en-Y gastric bypass surgery
* walk independently without assistive devices

Exclusion Criteria:

* scheduled to undergo knee surgery
* receiving dialysis
* being treated for cancer
Micropuncture vs. Standard Common Femoral Artery Access

Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Several strategies and devices have been employed to decrease the risk for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access and vascular closure devices. Randomized trial data has failed to demonstrate that fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis data has demonstrated that vascular closure devices decrease time to arterial hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do not reduce the incidence of vascular complications as compared to hemostasis achieved with manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the purpose of decreasing vascular access complications has not been examined in a randomized study to date.

The present study is a 552 patient randomized controlled clinical trial that will help determine whether femoral arterial access obtained using the Micropuncture Kit will reduce the incidence of vascular access complications compared to the standard 18 gauge needle.

The specific aim of this proposal is to compare the rate of femoral artery access complications using the Micropuncture Kit vs. standard femoral artery access.

It is our hypothesis that the incidence of femoral artery access complications will be lower among patients in whom the Micropuncture Kit is used.


Eligibility Criteria:
Inclusion Criteria: Patients undergoing left heart or peripheral catheterization through the common femoral artery with anticipated or possible percutaneous coronary or peripheral intervention

Exclusion Criteria:

1. Arterial access obtained through the radial or brachial artery
2. Age less than 18 years
3. Patients with known bleeding diathesis
Pre-pectoral Breast Reconstruction PART 1

The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.

This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:

the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM

* Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
* Prophylactic and therapeutic.

Included patients baseline characteristics will be:

* Age 18-80 years old
* BMI between 18.5 and 35.
* Former smokers (up until 3 weeks before surgery)
* Hypertension at oral medications
* Diabetes
* Previous breast surgery
* Previous breast and chest wall radiation therapy will be allowed.

Exclusion Criteria:

* T4 and metastatic breast cancers
* Obese patients (BMI over 35)
* Currently smoking patients (within 3 weeks before surgery)
* Refusal to sign the consent
* Severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk

This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women with IRM and 100 control women with a successful pregnancy will be included in this study. Then genotyping will be performed.

As a common occurrence in early pregnancy, IRM has been associated with multiple causes, among which the disorders of immune homeostasis between the fetus and the maternal immune system, maintained by cytokines from the complex regulatory network, are considered one of the potential etiological factors underlying IRM.

The IL-10 polymorphism -1082A/G (rs1800896), which is located in the promoter region of the IL-10 gene, was reported to be implicated in the abnormal expression of IL-10 in IRM by some studies.

However, no such reports about the association between IL-10 polymorphism -1082A/G and IRM risk in Chinese Han.

Eligibility Criteria:
Inclusion Criteria:

1. women with more than three consecutive unexplained pregnancy losses before the 20th week;
2. Chinese Han Population;
3. Patients who signed informed consent.

Exclusion Criteria:

1. Patients who had other high-risk factors which might relate with recurrent miscarriage, including: (1) Parental karyotype abnormalities: significant rearrangements (e.g. balanced translocations and mosaics) were considered abnormal. If either the patient (or her partner) had an abnormal karyotype, it was considered a parental karyotypic abnormality; (2) Genital tract abnormalities: Any congenital anatomical deformation of the genital tract was considered abnormal; intrauterine adhesions, endometriosis and hydrosalpinx were also considered abnormal; (3) alloimmune disorder; (4) Endocrine abnormalities: prolactin (PRL) level \>25 ng/ml, testosterone level \>2.6 nmol/L, thyroid-stimulating hormone level \<0.30 mU/L or \>4.5 mU/L, free thyroxine (FT4) level \<8.36 nmol/L or \>29.6 nmol/L and free triiodothyronine (FT3) level \<1.84 nmol/L or \>7.39 nmol/L. Glucose level \> 126mg/dl; (5) Autoimmune disorders: Any positive results of Anti-cardiolipin antibodies (ACA-IgG/IgM/IgA), anti-nuclear antibodies (ANA-IgG), anti-endometrium antibodies (AEA-IgM), anti-ovary antibodies (AOA-IgM), anti-sperm antibodies (ASA-IgM), antithyroidin(TG-Ab), anti-thyroid peroxidase antibody(TPO-Ab) and/or anti-chorionic gonadotropin hormone antibody; (6) Hypercoagulation state: D-dimer levels \>260 ng/ml, fibrin degradation products (FDP) levels \>5 mg/L or anti-beta 2-glycoprotein I (anti-beta 2-GP1) levels \>15 U/ml; (7) Negative RH blood groups; (8) Abnormal semen routine results of patients husband.
2. Patients with serious diseases;
3. Patients with administration of contraceptive pills;
4. Patients participated in other randomized clinical research;
5. Patients could not be followed-up of a long time or had poor compliance;
6. Patients with other factors that would affect the study result.
Zinc Effect on Inflammation and Cardiovascular Risk in HIV

To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy

This study will focus on subjects with documented zinc deficiency (levels \<75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Documentation of an HIV-1 RNA level of ≤400 copies/mL in the last 4 months prior to study entry
* Male or Female age ≥18 years
* Zinc level ≤0.75 mg/L in the last 60 days

Exclusion Criteria:

* Pregnancy/lactation
* Known cardiovascular disease
* Uncontrolled diabetes
System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)

Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient case prospectively collected from 1999 to 2016. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

AMI is one of the leading causes of mortality and morbidity in public health globally, as well as in China. Remarkable variations of repercussion time and clinical outcome have been noted, however little information is available about how shortened D2B time is incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about effectiveness of treatment for AMI during long-term recovery is limited. Practical and applied knowledge from large unselected population is needed to guide practice for improvement.

This study will enroll patients with a confirmed diagnosis of AMI consecutively in China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. At 1 month, and 12 month after discharge, participants will return to the clinic for follow up visits. This study will examine system delay that may affect patients recovery after a heart attack. Effective clinic path system, and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with acute myocardial infarction according to positive cardiac biomarkers (Troponin I/T, CK-MB or CK≥ local laboratory upper limit of normal values within 24 hours after initial presentation, and at least one of the following two supporting evidence of ischemia (ischemic symptoms occurring within 24 hours before admission or up to 72 hours for STEMI; ECG changes indicative of new ischemia).

Exclusion Criteria:

* Previously enrolled in the similar study
Shock Waves in Knee Arthritis

Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.

In recent years, shock wave therapy has received a lot of interest in the treatment of numerous musculoskeletal pathologies. This physical therapy exploits the cavitational effect induced on the tissues which translates into neo-angiogenic, anti-inflammatory, regenerative and analgesic action. Until now, the indication has been reserved for the treatment of tendinopathies and delayed consolidation of fractures. Pre-clinical research is also paving the way for the treatment of cartilage pathologies; in fact, after the stimulation of the chondrocyte, a modulation of the phlogogenic cytokines has been found, supporting a slowing down of the progression of the arthritic pathology. The first clinical experiences on arthritic models, such as rhizarthrosis, allow to support the indication also on the pathological model of gonarthrosis. The aim of this study is to verify the effects of shock wave therapy in the patient affected by gonarthrosis, monitoring the action on pain, functionality and tissue district changes.

Eligibility Criteria:
Inclusion Criteria:

* persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
* clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
* no history of physical therapy in the last 3 months,
* no infections, tumors in the treatment area of the knee,
* no pathology other than osteoarthritis that could cause knee pain,
* no pathology of the lumbar spine or hip that could refer knee pain,
* free from any condition that prevents participation in exercise or physical therapy willing to participate regularly in the treatment programs were included in the study.

Exclusion Criteria:

* inability to walk,
* a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
* evidence of a neurological disorder based on history or physical examination,
* generalized pain or fibromyalgia,
* secondary osteoarthritis (to metabolic or rheumatologic disease),
* administration of intra-articular injections (anesthetic, hyaluronic acid, cortisone) of the knee in the last 6 months,
* use of NSAIDs, paracetamol or topical agents in the previous week,
* a previous history of surgery involving the knee joint,
* contraindications to physical therapy (PM, epilepsy, neoplasia, coagulopathy, pregnancy).
Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential.


Eligibility Criteria:
Inclusion Criteria:

* Patients that reach American socity of anesthesiologist class 1-3
* Scheduled for VATS surgery under general anesthesia.

Exclusion Criteria:

* ● Allergy to local anesthetics

  * Patient with pleural inflammation due to recent pneumonia
  * Patients who are unable or unwilling to perform spirometer test
  * Renal dysfunction: (Elevated creatinine \> 2 mg\\dl)
  * Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
  * History of addiction
Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

The purpose of this study is to compare the effect on postoperative pain of a single agent nonsteroidal anti-inflammatory drug (NSAID) \[celecoxib plus placebo\] to an NSAID combination \[celecoxib plus acetaminophen\] administered preemptively to patients prior to impacted third molar surgery. .

This randomized, double-blind, placebo-controlled, prospective clinical trial is designed to compare the postoperative pain reduction of a single agent nonsteroidal anti-inflammatory drug (NSAID) and NSAID combination regimen administered preemptively. Subjects will be given a single oral dose of a cyclooxygenase-2 (COX-2) selective inhibitor (celecoxib 200mg), or celecoxib 200 mg in combination with acetaminophen (APAP 1000 mg) 30 to 60 minutes prior to the procedure. Oral surgery involving at least one impacted mandibular third molar will be performed using a combination of intravenous sedation and local anesthesia following UTHealth School of Dentistry (UTSD) surgical protocol. All subjects will be released with identical postoperative instructions and prescriptions for pain management. Nonopioid pain management will be prescribed as follows: 600mg ibuprofen with 500 mg APAP every 6 hours for the first 3 days, then as needed for pain. Subjects will be asked to document medication consumption, postoperative pain and complications for the following 3 days using a Qualtrics survey. An oral and maxillofacial surgery resident or faculty on call can offer emergency intervention with prescription of an opioid analgesic.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification 1 or 2
* at least 1 impacted mandibular third molar planned for extraction

Exclusion Criteria:

* ASA 3 or higher for physical status classification
* severe pericoronitis associated with third molar to be extracted
* any known allergies to NSAIDs, aspirin, acetaminophen, sulfa drugs
* history of cardiovascular or cerebrovascular disease
* hepatic disease or impairment
* pregnancy
A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years

This study is a multi-center, randomized, prospective single-sample correlational design without controls. A total of up to 310 previously-diagnosed type 1 or 2 diabetes subjects will be enrolled in order to have 160 subjects complete frequent sample testing at up to 17 centers. Subjects will wear Harmony 1 sensors used with the Guardian Mobile application.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 2-75 years of age at time of screening
* A clinical diagnosis of type 1 or 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
* Adequate venous access as assessed by investigator or appropriate staff
* Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion Criteria:

* Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individuals
* Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
* Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
* Subject is female and has a positive pregnancy screening test
* Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
* Subject is female and plans to become pregnant during the course of the study
* Subject has had a hypoglycemic seizure within the past 6 months
* Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
* Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
* Subject has a history of a seizure disorder
* Subject has central nervous system or cardiac disorder resulting in syncope
* Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
* Subject has a hematocrit (Hct) lower than the normal reference range
* Subject has a history of adrenal insufficiency