cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.

Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.

Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.

Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.

Eligibility Criteria:
Inclusion Criteria

* Are between the ages of 18-75 years
* Have clinical indications for whole sural nerve biopsy
* Have a sural nerve SNAP with amplitude \> or = 2 microvolt (μV)
* Are able to comply with protocol requirements
* Can provide written informed consent
* Willingness to complete study procedures

Exclusion Criteria

* Current smoker.
* History of prior musculoskeletal (joint or soft tissue) infection.
* Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
* Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
* Have diabetes mellitus.
* Have previous trauma to the biopsy site.
* Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
* Are pregnant or breast-feeding.
* Unwilling to use adequate contraception.
Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.

In this trial, participants will be given dexmedetomidine using a single-arm study design. fMRI will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after dexmedetomidine is administered.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 45
* Normal body weight and habitus, BMI ≤ 30
* Non-smoker
* American Society of Anesthesiologists (ASA) physical status classification P1
* Active health insurance coverage
* Fully vaccinated against COVID-19

Exclusion Criteria:

* Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
* Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
* Hepatic: hepatitis, jaundice, ascites
* Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
* Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
* Endocrine: diabetes, thyroid disease
* Renal: acute or chronic severe renal insufficiency
* Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
* Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
* Psychiatric: history or treatment for an active psychiatric problem, depression
* Reproductive: pregnancy, breast-feeding
* Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
* Allergies: dexmedetomidine, ondansetron, glycopyrrolate, phenylephrine
* Dermatologic: ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement.
* MRI reasons for exclusion: History of head trauma, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures, metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability

The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic activity in surgical patients. The study investigates whether a segmental sympathetic block can be determined and can be correlated to level of the sensoric blockade.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* combined anesthesia with thoracic epidural anesthesia 8 (Th6-9
* Body-mass-index \< 30

Exclusion Criteria:

* Fever, Hypothermia, SIRS
* Microangiopathy
* Neuropathy
* Sensomotoric deficits
Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.

The purpose of this study is to develop recommendations to assist in improving the current peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will consist of a needs assessment, a review of aggregate quantitative patient data from hospital records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers, laboratory technicians, patients and primary caregivers. The final report will be used to obtain funding for the implementation of the recommendations.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be affiliated with the PD program that is under evaluation

Exclusion Criteria:

1. Being physically unable to participate in an interview of approximately one hour
2. Being younger than 18 years of age
3. Refusal to participate
Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT

The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

This is a prospective, single-center, non-randomised, non-blinded trial with Tomosyntheis of Patients referred to the investigators institution to assess lung alterations and bone structure. All patients will undergo chest x-ray and tomosynthesis after informed consent. In addition they will undergo an ultralow-dose CT, wich is used as standart reference. The radiation dose of each method will be recorded. After completion of these three examinations, the participation in the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for evaluation of lung-changes
* Patients scheduled for evaluation of the wrist after fracture or surgery

Exclusion Criteria:

* general contraindications for x-Ray
* general contraindications for CT
* pregnancy
The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring surgical repair of the peroneal tendon
2. Patients who voluntarily consent to research participation
3. Patients over the age of 18

Exclusion Criteria:

1. Patients who display a high surgical risk as determined by the investigative surgeon
2. Previous surgical repair of the peroneal tendon less than 2 years prior to surgery
3. Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion
4. Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
5. Patients who are pregnant or breast feeding.
6. Patients who have had a clinically diagnosed autoimmune disease
7. Patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative immobilization period
8. Patients with an active infection
9. Patients who have a medical history that would likely make the patient an unreliable research participant
10. Patients requiring surgical repair of the peroneus longus tendon
Mindfulness Meditation in Bone Marrow Transplantation

The main purpose of this study is to examine techniques to help patients cope better with the stem cell/bone marrow transplant procedure.

Patients will be assigned to one of three study groups:

1. receives the normal standard care;
2. meets with an oncology nurse educator, in addition to the regular nurses on the transplant team. The nurse educator will provide information and answers to patient's questions about the stem cell/bone marrow transplant experience; or
3. is taught mindfulness meditation by a nurse who is trained to be a mindfulness instructor and by an audio CD.

Mindfulness meditation is a technique that may help in coping with the stress and difficulties associated with cancer and undergoing a stem cell/bone marrow transplant. It involves learning to be in the present moment by paying attention to your breathing, sights, and sounds, and to sensations you may be experiencing, or thoughts and feelings you may be having.

Mindfulness meditation has been shown to be helpful to patients in the clinic who have cancer and other medical conditions.

Patients, regardless of random group assignment, will complete a questionnaire 8 different times, from before they are admitted to the hospital until 6 months after discharge.

Patients will also provide two urine samples while in the hospital to measure the levels of stress hormones present in the urine.

Eligibility Criteria:
Inclusion Criteria:

* Autologous stem cell transplantation for hematologic malignancy
* First transplant
* 21 years of age or older
* Speaks and understands English

Exclusion Criteria:

* Planned tandem (more than one) transplant
* Taking corticosteroids on a regular basis for a chronic condition
* Prior formal mindfulness meditation training
* Significant cognitive impairment and/or confirmed psychosis or thought disorder
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study

Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study


Eligibility Criteria:
Inclusion Criteria:

* Single mandibular fracture.
* ORIF is done by two plates fixation with titanium plates and screws.
* Age (18-50 years).
* Recent fracture (less than 2 weeks).

Exclusion Criteria:

* Pathological fractures.
* Medical compromised patient.
* Presence of concomitant injuries.
* Patients receive radiotherapy.
* Patients receive blood transfusion.
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.


Eligibility Criteria:
Inclusion Criteria:

* active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings
* healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients

Exclusion Criteria:

* pregnant woman
* positive result of human immunodeficiency virus examination
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Pneumocystis prophylaxis.
* Antiretroviral therapy, or other experimental protocols.
* Antipyretics and analgesics as per the treating physician.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Unexplained fever.
* Night sweats.
* Unexplained anemia with hemoglobin \< 10 g percent or hematocrit less than 30 percent.
* Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
* Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.

Patients with the following are excluded:

* Known hypersensitivity to clofazimine.
* Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient).
* Any of the following symptoms at the time of study entry:
* Unexplained fever.
* Night sweats.
* Unexplained anemia with hemoglobin \< 10 percent or hematocrit less than 30 percent.
* Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
* Long-term (over 2 weeks) treatment with any drug with known significant anti-MAC activity.

Prior Medication:

Excluded:

* Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.

Group 1:

* AIDS patients with a first episode of Pneumocystis carinii pneumonia (PCP) within 2 to 4 months prior to study entry.
* Group 2:
* Patients with T4 counts \< 100 cells/mm3, regardless of prior opportunistic infections or malignancies.
* Karnofsky = or \> 70.
* All patients must sign informed consent.
Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome

The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age
* Molecular documentation of the fragile X mutation.
* Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate or higher at screening and at Visit 1
* An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score \>12 and at least 3 items on the Irritability Subscale rated at least moderate or above.
* Current treatment with no more than three psychoactive medications, including anti-epileptics.
* Current pharmacological treatment regimen has been stable for at least 4 weeks.

Exclusion Criteria:

* Subjects with a history of seizure disorder who are not currently receiving treatment with antiepileptics.
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who are currently receiving treatment with racemic baclofen.
* Subjects currently treated with vigabatrin or tiagabine.
* Subjects taking another investigational drug currently or within the last 30 days.
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)

The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.

Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.

Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.

Eligibility Criteria:
Inclusion Criteria:

1. age over 18 years
2. Histologically documented kidney cancer or hepatocarcinoma
3. Performance status more than / equal to 2
4. Life expectancy \> 12 weeks
5. in patients with recent surgery, the wound should be completely healed before taking Sorafenib
6. required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 9.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal Bilirubin less than/equal to upper limit of normal(ULN)
7. Appropriate patienty compliance

Exclusion Criteria:

1. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
2. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
3. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
4. Sintomatic brain metastases
5. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded
6. patients with seizures that need medical treatment
7. History of heterologous transplantation
8. Patients with previous or active bleeding
9. Dialysis patients
10. Patients with history of primary hyperparathyroidism
11. Dysphagic patients
12. Taking more than four weeks of entry into the study of other bio-chemotherapy treatments
13. Previous treatment with Sorafenib
14. Recent (\<6 months)or concomitant treatment with biphosphonate
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.

This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

Eligibility Criteria:
Inclusion Criteria:

1. age≥65 years;
2. undergoing major non-cardiac surgery;
3. scheduled for general anesthesia and endotracheal intubation;
4. American Society of Anesthesiologists (ASA) physical status classification I-IV;
5. with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
6. informed consent obtained.

Exclusion Criteria:

1. emergency surgery;
2. preoperative pneumonia;
3. allergic to chlorhexidine;
4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
5. expected intervention of immunonutrition\<3 days.