cyrilzakka/clinical-trials huggingface dataset:
Fibergraft Interbody Fusion Retrospective

A single center study of clinical and radiological outcomes in a retrospective cohort of patients treated with Lumbar Interbody Fusion augmented with Prosidyan Fibergraft for 1 or 2 level degenerative spinal disease by a single surgeon.

Study Design: Retrospective chart review with prospective data collection.

Background and Rationale: Degenerative pathologies of the lumbar spine including degenerative disc disease, spondylosis and spondylolisthesis are the leading indications for lumbar interbody fusion (LIF) among low back pain patients. Prosidyan's Fibergraft is a bioactive synthetic bone graft substitute that is ultraporous and made from bioactive glass fibers. The proposed study will be an analysis of clinical outcomes among patients who underwent lumbar interbody fusion augmented with Prosidyan Fibergraft by a single surgeon.

Objective(s):

PRIMARY: To assess the fusion rate in this retrospective cohort at 12 months post-operatively.

SECONDARY:

* To report and analyze trends (if any) among diagnosis, number of levels, approach (TLIF, LIF or ALIF) and fusion status.
* To assess pain and functional health changes pre to post-operatively. SAFTEY: To report the rate of surgical adverse events and subsequent surgeries at the operative level.

Study design: Retrospective chart review with prospective data collection.

Procedures: Patients will be screened by retrospective chart review. Eligible patients will be contacted and asked to participate. Consenting patients will answer questionnaires and undergo a CT lumbar scan.

Study Product / Intervention: The device under investigation is Prosidyan Fibergraft. However, since study subjects are retrospectively enrolled, they will have received the device before entering the study.

Eligibility Criteria:
Inclusion Criteria:

* - Previous Lumbar Interbody Fusion (LIF) at 1-3 levels augmented with Prosidyan Fibergraft Putty.
* No revision or device removal at the operative level(s).
* Patient did not undergo a Lumbar CT at least 8 months post-operatively.
* Willing and able to sign Informed Consent.
* Willing and able to complete questionnaires and undergo CT scan of the Lumbar Spine
Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial

* This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage.
* 4 visits
* Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.

This study evaluating naltrexone-acetaminophen in the acute treatment of migraine.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 75 years, inclusive.
2. At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition 17 (ICHD-3).
3. Migraine onset before age 50 years.
4. Read, write, and speak English
5. BMI Higher than 20 and Lower than 34
6. The female subject who is premenopausal or postmenopausal less than one year or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using two methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study medication (e.g., barrier with an additional spermicidal, intra- uterine device, hormonal contraception). Male subjects must be surgically sterile (the procedure occurred greater than 6 months before the Screening Visit) or commit to using two different birth control methods during the study and for 28 days after the last dose of the study medication.

Exclusion Criteria:

1. Pregnant or nursing women or those planning a pregnancy.
2. Used opioids (including methadone and buprenorphine), barbiturate-containing medications, muscle relaxants, or benzodiazepines within 3 months prior to screening.
3. Used any recreational drugs in the past 3 months.
4. Use of medications to treat headaches more than 10 days per month in the past 3 months or use of any pain medication for other pain syndromes for more than 10 days per month.
5. Uncontrolled cardiovascular or cerebrovascular disease or a history of heart failure, atrial fibrillation, or myocardial infarction.
6. Uncontrolled hypertension (systolic/diastolic blood pressure ˃ 140/90 mmHg) or diabetes.
7. Immediate family members or same household members participating in the study.
8. Site personnel, their friends, and family.
9. Abnormal laboratory or ECG results.

   1. Aspartate transaminase (AST/SGOT), alanine transaminase (ALT/SGPT), or alkaline Phosphatase ≥ 1.5 x Upper Limit of Normal (ULN). creatinine ≥ 1.5 x ULN.
   2. BBB or intraventricular conduction defect with a QRS duration ≥ 150 msec. ST-T wave abnormalities.
   3. Hemoglobin \< 10 g/dL
   4. Neutrophil count ≤ 1000/μL
   5. Cholesterol ≥ 300 mg/dL
   6. Triglycerides ≥ 500 mg/dL Additional exclusion criteria may apply.
Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines

Non-interventional PASS of NUCEIVA for the treatment of moderate-to-severe glabellar lines to provide additional characterisation of the long-term safety of NUCEIVA in the real-world clinical practice setting.

This is a prospective, multicentre, non-interventional observational Post Authorisation Safety Study; Safety data will be collected from approximately 750 patients at 20 sites throughout the United Kingdom and the European Union over an 18 month evaluation period. Eligible patients will receive an initial treatment of 20 Units of NUCEIVA. Further treatment will not be specified, recommended or required by the protocol. Patients may receive up to 6 treatments of 20 Units of NUCEIVA over the course of the 18-month study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is an adult less than 65 years of age
* Patient presenting to a participating physician has moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines)
* Patient finds their glabellar lines have an important psychological impact
* Written informed consent is obtained from the patient.

Exclusion Criteria:

* Patient has a legal incapacity or limited legal capacity without legal guardian representation
* Patient is currently participating in an interventional study of any investigational product, device or procedure
* Patient has a hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the Summary of Product Characteristics
* Patient has a generalised disorder of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome)
* Patient has an infection or inflammation at any of the proposed injection sites
* Patient has a history of dysphagia and/or aspiration
* Female patient is pregnant, is of childbearing potential and not using contraception, is breast feeding, or is planning to become pregnant during the next 18 months
* Patient has received prior botulinum toxin for any indication within 3 months of study enrolment.
Dermal Photo Allergic Skin Reaction

A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female who were 18 years of age or older
* Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

* Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
* Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfigurations of the test site
Vitamin D for Cognition in Bipolar Disorder

Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.

Bipolar disorder (BD) is a chronic mental disease related to recurrent episodes along with cognitive or functional decline. Comparing efficacy of pharmacological interventions targeting to treat cognitive deficit in BD is unexplored. The majority of the observational studies demonstrate a significant association between low serum vitamin D and compromised cognition in a wide range of neuropsychiatry diseases. Recent survey further revealed the high prevalence of hypovitamin D in BD. The effect of supplement and association between vitamin D and cognition in BD and the underlying mechanism is unclear.

The investigators will collect vitamin D levels and assess their association with cognition in a euthymic bipolar cohort (N=200) for screen. Then, the investigators estimate to recruit 120 of participants with cognitive deficits and combined vitamin D deficiency, to conduct a RCT. Participants will keep their usual treatment and will be randomized to receive either vitamin D supplement or a placebo for eight weeks. Cognitive test, adverse side effect, mood status and blood 25(OH)D levels and biomarkers will be measured before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who diagnosed with BD-I based on the Diagnostic and Statistical Manual (DSM-IV) criteria are consecutively referred by board-certified psychiatrists in Taipei City Hospital, Songde branch.
2. Age of participants should range from 20 to 65 years old.
3. No history of vitamin D supplementation within three months before the study.
4. The BD patients in their euthymic state (both Hamilton Depression Rating Scale and Young Mania Rating Scale ≤ 8) and no change of their psychoactive medications in recent three months.

Exclusion Criteria:

1. With known substance use disorder (except nicotine use disorder)
2. With any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions)
3. Comorbid with schizophrenia spectrum disorders
4. With active physical condition (such as renal impairment, hepatic failure...) or pregnancy
5. Inability to complete the standard assessment or incapability of providing informed consent
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory
2. Prior therapy in the advanced/metastatic setting
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Has adequate bone marrow and organ function

Exclusion Criteria:

1. Uncontrolled significant active infections
2. Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug
3. Inability to take oral medication or presence of malabsorption
4. Active cardiac disease or a history of cardiac dysfunction
5. Evidence of ongoing Alcohol or Drug Abuse
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy

The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria:

* Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
* Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)

Key Exclusion Criteria:

* Known Human Epidermal growth factor Receptor2 (HER2) positive status
* Radiological evidence of brain metastases
* History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
* Inadequate hematologic, renal and hepatic function
NOVAPAK Nasal Packing in Shellfish Allergic Patients

NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.

This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.

The primary objective is to assess the safety of Novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy.

The study will be conducted in two phases. First, participants will undergo an allergy test - Skin prick test (SPT) to crab, lobster, shrimp, oyster, clam, scallop, squid, and octopus -, and antibody levels analysis. Second, in a controlled setting (i.e., in a hospital clinic that includes a resuscitation cart and doctors monitoring - allergist and otolaryngologist), Novapak packing will be applied to the patient's skin for 30 minutes (on the anterior aspect of the patients' non-dominant arm). Then, provided that no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine, and a piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.

Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60
* Positive history of shellfish allergy
* Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.

Exclusion Criteria:

* Severe lung diseases: severe asthma, obstructive lung disease
* Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.
* Severe cerebrovascular disease: history of stroke or severe carotid stenosis.
* Presence of beta-blocker mediations.
* Patients unable to discontinue antihistamine medications or prednisone.
* Patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis.
* Pregnancy
Monocentric Registry to Investigate the Role of Platelet Function, Platelet Genetics, Proteomics and Metabonomics in Heart Disease

Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with ischemic and non-ischemic heart disease
2. informed consent by patients or relatives in case of missing capacity to consent due to health status

Exclusion Criteria:

1. Patients \<18 years
2. missing informed consent
Changing Health Through Food Support (CHEFS) Program

UCSF and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct an initial randomized controlled trial (RCT) of the Changing Health through Food Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing comprehensive, medically-appropriate food support, individual nutritional counseling, and group-based nutritional education over 6 months to low-income clients who have been diagnosed with HIV in order to improve their viral load and health-related quality of life (primary outcomes) as well as depression, ART adherence, food security and diet quality (secondary outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100). Participants will be followed for 6 months. The investigators will assess outcomes at baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the investigators will conduct a qualitative study at follow-up in a subset of participants to understand perceived impacts, barriers and facilitators.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Income at or below 200% FPL (\~$2400/month)
* 30-50% minimum POH regular program adherence level (i.e. regular service access rate)
* Are willing and able to eat food from POH based on one of POH's regularly available diet choices (including regular, non-dairy, vegetarian, vegetarian non-dairy, diabetic, and bland), excluding the renal diet.
* Have access to a refrigerator or freezer with sufficient space to store perishable food provided by POH, and have access to an appliance to reheat food.

Exclusion Criteria:

* Do not speak Spanish or English
* Do not have adequate cognitive or hearing capacity to complete interviews
* Have a history of violent behavior at POH (such as verbal or physical abuse to other clients and/or staff)
* Have renal disease requiring a special renal diet
* Have severe food allergies
* Currently pregnant or \<6 months post-partum
* Unable to complete an interview due to a health condition
* Unable or unwilling to eat food from POH (based on one of POH's regularly available diet choices)
* Among people who share a household (such as partners, family members, or roommates), only one may be involved in the study.
External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy

The morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago.

Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged postoperative pain may cause early ambulation and delay performing deep breathing exercises.

Using regional anesthetic techniques results in less opioid use and better pain management. External oblique internal costal block; It is a new block that provides dermatomal sensory blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be used as part of multimodal analgesia in laparoscopic cases.

There is no study in the literature regarding the use of external oblique plane block in bariatric surgery yet.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Laparoscopic Obesity surgery

Exclusion Criteria:

* Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia

Postoperative pain may be affected by general anaesthetics. The effect of propofol and sevoflurane on postoperative pain in chinese female patients has not been demonstrated before. This study compared the postoperative pain score in patients under general anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.

After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of female patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I or II, suffering from infertilities, and undergoing selective gynaecological laparoscopic and hysteroscopic surgery. All the patients were randomly assigned to receive propofol,sevoflurane,or sevoflurane+propofol for anaesthesia maintenance. The primary outcome measure was the level of postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 0.5 hour after the operation. The secondary outcomes were postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 1 and 24 hour after the operation, the incidence of postoperative nausea and vomiting, the incidence of shiver, and quality of recovery determined by QOR40 in the first 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class 1 or 2
* Aged \>=18 years and =\<40 years old
* Suffering from infertilities
* Under elective gynaecological laparoscopic and hysteroscopic surgery

Exclusion Criteria:

* ASA-PS\>=III
* Aged under 18 yrs or above 40 yrs old
* Body mass index (BMI) \>30
* Respiratory or Neurologic disease
* Chronic antidepressants and Anticonvulsant drugs
* Chronic analgesics intake
* A known allergy to the drugs being used
* History of substance abuse
* Participating in the investigation of another experimental agent
* Participating in the investigation of another study