cyrilzakka/clinical-trials huggingface dataset:
Humanitarian Device Exemption

The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose ages are in the range of 7 and 99 years old
* Patients who are diagnosed with chronic, intractable (drug refractory)primary dystonia, including generalized and or segmental dystonia, hemidystonia, and cervical dystonia (torticollis)as determined by a neurologist or neurosurgeon.
* Patients who have failed appropriate medical therapy as determined by the SMD conference

Exclusion Criteria:

* Patients younger than 7 years old
* Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist.
* Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference.
* Patients not deemed good candidates by the SMD conference group.
Effect of Variable Volume Ventilation on Lung Compliance

Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.

Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation (VVV) with a constant volume decelerating flow (PCV pressure controlled volume guarantee) ventilation.

After anesthesia induction patients are VVV or PCV ventilated with a positive end expiratory pressure (PEEP) of 10 cm H2O. Average tidal volume is set at 6 ml/kg and end tidal CO2 is kept between 30 and 50 mmHg in both groups by adapting breaths per minute between 10 and 16. I/E ratio is set at 1/1 in VVV and at the standard ½ in PCV.

Dynamic lung compliance is measured before and during pneumoperitoneum. If dynamic lung compliance is less than 40 or decreases below 40 a first lung recruitment (10 sec of 30 up to 40 cmH2O) is given till dyn compliance rises above 40.

Dynamic lung compliance is further monitored and when value decreases again below 40, a new lung recruitment (LRM) is given and the PEEP is increased to 15 cm H2O after the second LRM.

All patients get an opioid free general anesthesia with anti inflammatory agents and deep NMB with full reversal at end of surgery.

The moment and number of LRM performed after induction of anesthesia with the averaged reached lung compliance is used to compare both ventilation methods.

The oxygen saturation without oxygen at arrival of PACU and the need for oxygen when saturation drops below 95 % are compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria:

* lung disease requiring oxygen before anesthesia
* emergence procedure
* spontaneous or assisted ventilation
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

The purpose of this signal seeking study is to determine whether treatment with PDR001 and LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.

This was a phase II, open-label study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. There were 7 tumor cohorts assessed: 1) Small cell lung cancer, 2) Gastric/esophageal adenocarcinoma, 3) Castration resistant prostate adenocarcinoma (CRPC), 4) Soft tissue sarcoma, 5) Ovarian adenocarcinoma, 6) Advanced well-differentiated neuroendocrine tumors and 7) Diffuse large B cell lymphoma (DLBCL).

Participants were treated with the combination of PDR001 300 mg with LAG525 400 mg once every 3 weeks (Q3W) via intravenous (i.v.) infusion. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma criteria (Cheson et al 2007)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study had to meet all of the following criteria:

* Patient must have had at least one prior line of therapy for their disease and must not be beyond 4th progression/relapse of disease (5 maximum prior lines).
* Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section "condition". Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007).

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

* History of severe hypersensitivity reactions to other monoclonal antibodies.
* Impaired cardiac function or clinically significant cardiac disease.
* Active, known or suspected autoimmune disease or a documented history of autoimmune disease within three years prior to screening with a few exceptions as per protocol.
* Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
* Patient with second primary malignancy within \< 3 years of first dose of study treatment.
* Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.
Closed-loop cTBS for the Core Clinical Features of Methamphetamine Use Disorder

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop continuous Theta-burst Stimulation (cTBS) based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop cTBS methods.

The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive continuous Theta-burst Stimulation (cTBS) , predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 60 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
* Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
* A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
* Consent to actively cooperate in the completion of subsequent follow-up assessments.

Exclusion Criteria:

* Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
* A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
* Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
* Severe organic diseases that might compromise study participation.
* Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.

Low-temperature applications were originally employed by the Egyptians to treat pain, and subsequently during the Franco-Prussian War for severed limbs. Hippocrates advocated the application of cold to lessen bruising, bleeding, and discomfort, while John Hunter wrote in 1777 that "the local tissue response to freezing includes local tissue necrosis, vascular stasis, and excellent healing." Using a solution of salt and ice, James Arnott (1851) was the first to describe and demonstrate this freezing technique for malignant breast tumors.

The term "cryotherapy" was used in 1908 to describe the use of extremely low temperatures to cure skin lesions. Currently, cryotherapy involves cooling the body's surface without destroying tissue, whereas in cryosurgery, sick tissues are frozen to death.

In the technique, several cryogens include: liquid nitroglycerine (-196 °C), Nitrous oxide (0°C), Solid CO2 (-78o C), Chlorodifluoromethane (-41°C), Dimethyl ether (-24 °C) and propane (-42 °C).

The intralesional technique, open method, or closed method can all be used to apply cryogens. The best application approach for big superficial cutaneous lesions is an open spray technique, in which the spray's nozzle is situated 1 cm away from the skin's surface, and the lesion is destroyed using either a paintbrush technique or a spiral technique.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients who had benign intraoral epithelial lesions free of infection.

Exclusion Criteria:

* Patients with Reynaud's illness.
* Cold sensitivity.
* History of diabetes.
* Severe infections.
* Patients who had cryoglobulinemia.
* Cold urticaria.
* Patients who was receiving hemodialysis.
* Patients who was receiving immunosuppressive medication.
The Effectiveness of 3D VR Training System for Supporting Volunteers on Adolescents' Illegal Drug Use

The purpose of that study was to apply the 3D virtual reality technology to develop a training program aiming at improving the abilities of problem solving, self-efficacy and teamwork of supervisory volunteers on adolescents' illegal drug use.

Use of illegal drug among adolescents is one of the critical health problems in this age group. The purpose of that study was to apply the 3D virtual reality technology to develop a training program aiming at improving the abilities of problem solving, self-efficacy and teamwork of supervisory volunteers on adolescents' illegal drug use. This study used a randomized controlled design with recruiting 68 participants. The participants in the experimental group received the 3D VR training program and the counterparts in the control group did not receive any intervention. The participants in the experimental group performed better on problem solving, self-efficacy and teamwork. In addition, the scores of technology use related variables also supported that experimental participants favored the 3D VR training system. The findings suggested that the 3D VR training system enhanced the supporting volunteers' abilities to deal with adolescents' illegal drug use. The 3D VR program showed potential for future promotion to supporting volunteers that contribute to improve volunteers' abilities on dealing with adolescents' illegal drug use.

Eligibility Criteria:
Inclusion Criteria:

* accompanies at least an adolescent with drug use to
* having less than 2 year of supporting experiences
* having experiences of using technology products
* able to operate SVVR.

Exclusion Criteria:

* the volunteers who were suffering from cybersickness.
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).

Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.

In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.

The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.

Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).

Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.

In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.

The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old
* chronic aspirin treatment
* first CT scan less than 12 hours following the trauma
* GCS \>3
* no immediate surgical cranial lesion
* isolated head injury
* consent
* contusions \>1.5cc or acute subdural hemorrhage in any size

Exclusion Criteria:

* anticoagulation treatment
* more than one antiaggregate
* coagulopathy
* thrombocytopenia (less than 100000)
* intracranial tumor
* active hematological disease
* more than 8 hours between first and second CT scan
* more than 2 hours between first CT and platelet admission
DLBS1033 for the Treatment of Acute Ischemic Stroke

This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.

Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.

After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age of 18-75 years .
* Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
* Modified National Institutes of Health Stroke Scale (mNIHSS) score \>= 5.
* Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
* Able to take oral medication.

Exclusion Criteria:

* For females of childbearing potential: pregnancy and lactation period.
* History of or current hemorrhagic stroke (within the last 3 months).
* Transient ischemic stroke (TIA).
* Patients with seizure at the onset of stroke.
* History of serious head injury within the last 3 months.
* History of major surgery within the last 3 months.
* Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
* Presence of severe renal or hepatic dysfunction
* Presence of acute or chronic infections.
* Thrombocytopenia (thrombocytes level \< 150.000/ul).
* Patients with higher risks of bleeding.
* Uncontrolled hypertension (systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg).
* Random plasma glucose \>= 200 mg/dL.
* Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
* Hypersensitive to the investigational product(s).
The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients

Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but \<35 pg and RBC ≤350×104/μL; and MCH \<30 pg and RBC \>350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but \<12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be controlled with hemoglobin levels between ≥10 g/dL and \<12 g/dL and had undergone maintenance HD for \>1 year.

Exclusion Criteria:

* Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.
Endocrinological and Neuronal Aspects of Bariatric Surgery

The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* planning to undergo bariatric surgery
* planning to take part in a conservative diet

Exclusion Criteria:

* inability to undergo fMRI
* psychiatric disorders
* metabolic disorders
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction

The aim of the study is to investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 100 years
* patients discharged alive with STEMI or NSTEMI

Exclusion Criteria:

* patients who die in hospital
* patients not discharged with STEMI or NSTEMI
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome


Eligibility Criteria:
Inclusion Criteria:

* Male/female at least 18 years of age
* Agree to avoid disallowed medications
* Have a diagnosis of dry eye

Exclusion Criteria:

* Have chronic systemic inflammation
* Have active seasonal ocular allergies