cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy mFOLFIRINOX in Locally Advanced or Metastatic Cholangiocarcinoma

The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

Eligibility Criteria:
The inclusion criteria included: patients aged 18-70 years old, regardless of gender; patients with locally advanced or metastatic CCA diagnosed by imaging and pathology; modified FOLFIRINOX regimen or Gemox regimen as first-line treatment; ≥ 1 focus that can be evaluated by imaging examination.

Exclusion criteria included: incomplete clinical history data; suffering from other malignant tumors within 5 years, except basal cell carcinoma and cervical carcinoma in situ; having received other systemic chemotherapy, targeted therapy, immunotherapy or radiotherapy as first-line treatment; with severe organ dysfunction.
Three Anxiolytic Drugs Used in Third Molar Surgery

This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

In this research, characterized as a randomized, double-blind, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* indication of bilateral extraction of asymptomatic, impacted mandibular third molars

Exclusion Criteria:

* patients under the age of 18 any general health problem based on the medical history and physical examination history of use of any medication within 15 days before the beginning of the research history of hypersensitivity to drugs, substances or materials used in this experiment pregnancy or lactation history of pericoronitis
Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder

Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease relapse risk in addiction. However, little is known about the relapse rates in cocaine addiction after tDCS, despite the need for neurobiological treatments to reduce the high relapse rates in this population. The current study explores the effects of repetitive tDCS in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three months. We expect that a decrease in relapse risk after tDCS is associated with cognitive control functioning. Therefore, risky decision making and inhibitory control will be measured before and after the interventions, and at three months follow-up. Ecological momentary assessment (EMA) will be used as a reliable measure for relapse, craving and mood.

For this study, 60 cocaine addicted patients will receive real or sham bilateral tDCS (left cathodal/right anodal) over the DLPFC after one week in detox. The participants will receive this two times daily for 5 consecutive days. It is expected that this particular tDCS method will reduce relapse probability, as was previously seen in alcohol addicted patients. Furthermore, it is hypothesized that this therapeutic effect is associated with diminished craving and enhanced cognitive control. Craving, temptations and relapse, will be explored by means of Ecological Momentary Assessment (EMA). The mixed results in previous studies of tDCS on craving may be explained by the fact that craving in addiction is a momentary phenomenon which is difficult to reliably measure with more traditional methods like retrospective self-reports, for which EMA provides a solution. Cognitive control will be measured by means of inhibitory control during a Go/NoGo task and reward processing during a gambling task. The tasks will be performed at baseline, one day after the tDCS sessions and at three months follow up.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years
* Meeting the DSM-V criteria for cocaine dependence
* The ability to speak, read, and write in Dutch at an eight-grade literacy level
* No severe withdrawal signs or symptoms at baseline

Exclusion Criteria:

* Indications of severe psychopathology (psychosis, severe mood disorder) as assessed by a physician
* A diagnosis of epilepsy, convulsions or delirium tremens during abstinence of cocaine use
* Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
* Pregnancy or breast-feeding.
Effect of Subanesthetic Dose of Esketamine on Sleep Quality and Recovery of Gastrointestinal Function in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery in the Early Postoperative Period

Patients undergoing gynecological surgery are at high risk of developing postoperative sleep disorders. Intraoperative opioid use is detrimental to the patient's postoperative recovery of gastrointestinal function. Esketamine has sedative, hypnotic, analgesic, inflammatory response suppression, and antidepressant effects. Its hypnotic mechanism may be related to its rapid blockade of NMDA receptors and hyperpolarization-activated cyclic nucleotide-gated cation channels. Also can reduce the application of perioperative opioids, which in turn promotes the recovery of gastrointestinal function in patients after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 65 years;
2. ASA class I-III;
3. Proposed laparoscopic total hysterectomy/myomectomy;
4. Operative time ≥ 1 h;
5. Body mass index of 18-30 kg/m2.

Exclusion Criteria:

1. Patient refusal;
2. Known allergy to anesthetic drugs;
3. Preoperative sleep disorder (Pittsburgh Sleep Quality Index \[PSQI\] \> 7);
4. Severe hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, pulmonary heart disease, increased cranial pressure, increased intraocular pressure, seizures, shift work, obstructive sleep apnea syndrome;
5. Long-term use of opioids or sedative-hypnotic drugs;
6. History of psychiatric or neurological disease;
7. Previous or planned neurosurgery.

(7)hearing or visual impairment that precludes a scale assessment.
A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration

The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event.

The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.

The present study will use non-invasive respiratory inductance plethysmography(RIP) and transcutaneous carbon dioxide measurement to compare recovery of respiration under constant Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet ventilation HFJV (study method) with recovery of respiration during rising and apnea (current standard).

The investigators hypothesize that the prolonged abdominal expiration that we observed during recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2) levels.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients ages \> 18 to \< 80
2. Scheduled for procedures under general anesthesia with jet ventilation
3. Sign informed consent
4. Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)

Exclusion Criteria:

1. Absence of informed consent
2. No planned use intra-operative use of jet ventilation
3. Known difficulties with jet ventilation during prior surgical procedures
4. Emergency surgery
5. Baseline (oxygen saturation)SpO2 \<92% on room air
6. BMI \> 50
7. Pregnant or lactating females
8. Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.

The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions\>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Can give informed consent to trial participation
* Lesion size greater than 20 mm
* Lesion proximal to and inclusive of mid transverse colon
* Laterally spreading or sessile polyp morphology

Exclusion Criteria:

* Previous resection or attempted resection of lesion
* Clip deployed prior to the completion of the EMR
* Major intraprocedural bleeding not treatable by coagulation
* Endoscopic appearance of invasive malignancy
* Age less than 18 years
* Pregnancy
* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
* Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
* American Society of Anesthesiology (ASA) Grade IV-V
A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants

The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).


Eligibility Criteria:
Inclusion Criteria:

* Parent(s) (preferably both if available or as per local requirements)/guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study, and potential risks and benefits of the study, and are willing to allow their child to participate in the study
* Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions
* The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place
* Infant must be healthy in the investigator's clinical judgment (and the parent(s)/guardian) on the basis of medical history, physical examination, vital signs and clinical laboratory tests performed at screening
* Infant has received all routine immunizations appropriate for his or her age at the time of enrollment as documented in the vaccination cards presented by the parent(s)/guardian. Participants are allowed to catch up on routine immunizations if needed (support for beneficial vaccines may be offered to participants)
* Extension Phase: Prior enrollment in the control arm of the main study and did not withdraw consent, and receipt of at least the first vaccination (Dose 1) in the main study

Exclusion Criteria:

* Having received any candidate or other Ebola vaccine
* History of Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening
* Having received any experimental candidate Ad26- or modified vaccinia ankara (MVA)-based vaccine in the past
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines \[for example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine and Neisseria meningitidis polysaccharide or tetanus toxoid for MenACWY\]), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin)
* Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or axillary temperature greater than or equal to (\>=) 37.5 degree celsius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
* Extension Phase: Having received any candidate or other Ebola vaccine
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder

The study will examine the effects of eight weeks of equine assisted activities (EAA) on co-regulation, basal physiological values, and symptom severity in veterans with post-traumatic stress disorder (PTSD). Heart rate, respiration rate, surface electromyography (EMG) and plasma concentrations of cortisol, epinephrine, norepinephrine, and oxytocin will be measured at rest and during dyadic interaction tasks (human to human or human to horse) to assess effects of EAA on these measures. Additionally, standard and regularly used questionnaires will be used to monitor PTSD symptom severity during the study and 6-month follow-up period. EAA is expected to lower PTSD symptom severity, and mitigate other physiological changes associated with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* male
* was deployed and experienced combat in Iraq or Afghanistan
* between 18 and 65 years of age

Exclusion Criteria:

* female
* amputation
* severe traumatic brain injury
* schizophrenia, bi-polar disorder, or substance dependence in the last 3 months
* pacemaker
* allergies to horses
* previous enrollment in equine assisted activities or psychotherapy in an equine environment
Optical Clearing of the Skin in Conjunction With Laser Treatments

The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in

1. decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group.
2. greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group.
3. greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older
* Lesion diagnoses in an area measuring 3 cm2 or more on any body site
* Apparent good health

Exclusion Criteria:

* Pregnant women
* History of cutaneous photosensitivity
* History of photodermatoses
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

Research study to determine if putting local anesthetic through a tiny tube next to the nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder procedure performed on the frozen shoulder. It will also help determine if patients have a higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their post-procedure pain control.

Primary Specific Aim: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in increased shoulder abduction following treatment for adhesive capsulitis of the shoulder.

Hypothesis: Following shoulder manipulation under a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve blcok to usual and customary post-manipulation analgesia will result in a significantly greater shoulder abduction improvement the day following the manipulation.

Secondary Specific Aims: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in an increased quality-of-life and shoulder range-of-motion, as well as a decreased chronic pain following treatment for adhesive capsulitis of the shoulder.

Hypothesis 1: Following shoulder manipulation under a single-injection interscalene blcok for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and customary post-manipulation analgesia will result in a significantly increased quality-of-life improvement and shoulder range-of-motion compared wiht baseline values after three months.

Hypothesis 2: Following shoulder manipulation undera a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and costomary post-manipulation analgesia will result in a significantly decreased chronic pain compared with basedline falues after three months.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing theraputic manipulation for adhesive capsulitis of the shoulder
* age 18 years or older
* accepting a single-injection nerve block for manipulation
* understanding possible perineural infusion-related complications, study protocol, and catheter/pump care
* having caretaker through the first night after manipulation
* having an ASA physical status classification of 1-3

Exclusion Criteria:

* Any contraindications for a CISB
* any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
* known allergy or other contraindication to the study medications
* pregnancy
* known hepatic or renal insufficiency/disease
* peripheral neuropathy of the surgical extremity
* morbid obesity
* inability to communicate with the investigators and hospital staff
* moderate-to-severe shoulder arthritis
* immunocompromised status of any etiology
* incarceration
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.

This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
* Not amenable to treatment with curative intent
* Adequate bone marrow and organ function

Exclusion Criteria:

* Impaired heart function
* Uncontrolled tumor in the brain
* Other active cancer
A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)

The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)；
* The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor \<2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ；
* No evidence of tumor metastasis on all per-operative evaluations；

Exclusion Criteria:

* 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension;
* 2. Patients with advanced malignant tumor;
* 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor;
* 4.Patients with ulcer penetration into tumors;
* 5. Patients with the contraindications for general anesthesia;
* 6. Patients were pregnant or younger than 18 years old；
Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology

The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).

A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years of age.
2. Being evaluated for acute ischemic stroke.
3. Able to safely wear the study device for up to 2 minutes per reading.
4. Have NIHSS performed before before study device monitoring.
5. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent).

Exclusion Criteria:

1. Known or suspected traumatic brain injury, either closed or penetrating.
2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography.
3. Presence of any implanted electro-stimulating devices in the head and neck.
4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.)
5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
6. Under arrest or otherwise in custody.
7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.).
8. Pregnant or nursing.
9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.