cyrilzakka/clinical-trials huggingface dataset:
Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain

Chronic Post thoracotomy pain syndrome (PTPS) is defined PTPS as pain that develops or increases in intensity after a thoracotomy and persists beyond the healing process, that's to say at least 3 months after the initiating event. The pain has to be localized to the site of incision or, projected to the innervation territory of a nerve situated in this area or referred to a dermatome or Head's zone (after surgery/injury to deep somatic and visceral tissues The incidence of PTPS is 57% and 47% of patients at 3 and 6 months after thoracotomy, respectively.

Management of PTPS begins with prevention. Preventive strategies are based on multimodal preemptive and intraoperative analgesia. Treatment of PTPS is either pharmacologic treatment which is systematically initiated by first line drugs including tricyclic anti-depressants (TCA), serotonin-norepinephrine reuptake inhibitors (SNRI), gabapentinoids. Second-line treatments include topical lidocaine, capsaicin, and weak opioid analgesics (tramadol). Third line treatments consist of strong opioids (oxycodone, morphine) and subcutaneous botilinium toxin injection.

Other therapies for management of CPTP include such modalities as transcutaneous electrical nerve stimulation (TENS), Spinal cord and peripheral nerve stimulation, acupuncture and neurolysis using pulsed radiofrequency for intercostal nerve or dorsal root ganglio and cryoneurolysis for intercostal nerve. The mode of action of pulsed RF is not well-understood, but may include inhibition of excitatory C-fiber responses by repetitive, burst-like stimulation of A-delta fibers, global reduction of evoked synaptic activity and minor structural changes in nerve tissue; elicited by alterations in the function of the blood-nerve barrier, fibroblast activation and collagen deposition.

The aim of the work is to evaluate the effect of oral pregabalin and pulsed radiofrequency ablation (PRF) ablation of the dorsal root ganglion (DRG) in the treatment of chronic post thoracotomy pain syndrome, using Visual Analogue Scale (VAS) score.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status III or IV
* Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics

Exclusion Criteria:

* Patient refusal
* The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
* coagulopathy
* Uncooperative patients
The Effect of Prescription Medications in Marijuana Users

A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.


Eligibility Criteria:
Inclusion Criteria:

* current use of marijuana
* able to give informed consent

Exclusion Criteria:

* dependence on drug other than marijuana
* pregnant, breast feeding, or planning to become pregnant within the next 3 months
* currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
* use of cannabis under the guidance of a physician for a medical disorder
* unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
* allergy to study medication
Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection

As of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5).

One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols.

The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.

Electronic patient records for patients who attended the Emergency Department (ED) and Acute Assessment Unit (AAU) at Glasgow Royal Infirmary (GRI), Glasgow, U.K., during the initial 7-week period of the COVID-19 pandemic in Glasgow city (17th March 2020 - 1st May 2020) were examined for routine clinical, laboratory and clinical outcome data. GRI is a university teaching hospital that serves an urban population with a high burden of socio-economic deprivation and offers the full spectrum of adult acute receiving specialties to patients over 16 years old. In line with NHS policy, this study was approved by the NHS Greater Glasgow and Clyde Caldicott guardian.

Eligibility Criteria:
Inclusion Criteria:

* Clinical, radiological and PCR positive COVID-19 diagnosis

Exclusion Criteria:

* less than 18 years old
Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET

The investigators are evaluating the acceptability and effectiveness of brief online wellness modules. Participants will be randomly assigned to the intervention condition, an active control condition, or a wait-list control condition. The investigators are using a factorial design, such that each participant in the intervention condition will be randomly assigned to receive three of four wellness modules.

The investigators will analyze the intervention's effectiveness as a universal intervention (using the full sample) and a targeted intervention (using the subset of the sample that reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility Criteria:
Adult participants (at least 18 years old) will be eligible for this study.
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.

Exercise-Induced Bronchospasm (EIB) affects between 7-30% of highly trained athletes. The first phase of this study is to screen varsity level college athletes for EIB using Eucapnic hyperventilation (EVH). Those athletes who screen positive, will be enrolled in phase two, a randomized double-blinded placebo controlled double crossover study. At enrollment, athletes will undergo a cardiopulmonary stress test (CPST) and induced sputum sampling and will then be prescribed daily montelukast/placebo for a three week period. Athletes will return after three weeks and repeat the EVH, CPST, and induced sputum. They will then have a one week washout period followed by crossover once again to daily montelukast/placebo for another three weeks. After the second three weeks they will once again return for a final EVH, CPST, and induced sputum. The goal of this study is to demonstrate that effectively blunting the EIB response with montelukast, indices of ventilation,exercise tolerance, and perhaps overall physical fitness improve, allowing athletes to train more effectively, in a nonergogenic manner.

Eligibility Criteria:
Inclusion Criteria:

* College level varsity athlete
* age 18yr or older
* healthy.
* Able to swallow pills
* No prior history of asthma

Exclusion Criteria:

* Younger than 18yr
* smoker
* Prior history of asthma
* Unable to swallow pills
Calorie Anticipation and Food Intake

The regulation of our food intake is on the short-term guided by appetite and satiety signals generated by the sight and consumption of food. Food intake is not only regulated by appetite and satiety signals - external cues also play an important role.

It has been observed that food intake and the pleasure derived from consumption is affected by manipulation of the external cues.

The investigators will assess the contribution of food anticipation (calorie information) and actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin responses, appetite and subsequent food intake). The investigators expect the information on the amount of calories, rather than the actual amount of calories in the food, to predict the ghrelin responses and the subsequent intake of a second meal.

In a randomized cross-over design with 4 conditions, all participants will consume twice the low-caloric food (once with the low-calorie information and once with the high-calorie information) and twice the high-caloric food (again, once with the low-calorie information and once with the high-calorie information) in a randomized order.

Eligibility Criteria:
Inclusion Criteria:

* female
* healthy
* being used to eat breakfast regularly (≥ 5 times a week).

Exclusion Criteria:

* hypersensitivity for the ingredients of the foods under study;
* lack of appetite; following an energy-restricted diet or change in body weight \> 5 kg; or
* being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea.
One Brand-new Maneuver to Place Nasoenteric Tube

Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.

Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.

Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.

Eligibility Criteria:
Inclusion Criteria:

1. Esophageal obstruction
2. Gastric outlet obstruction
3. Duodenal obstruction
4. Pancreatitis
5. Gastroparesis -

Exclusion Criteria:

* (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.

The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.

The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subject, ≥ 18 years of age at time of enrollment.
2. Subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and/or thrombectomy procedure, where one of the LeMaitre® Embolectomy Catheter will be used.
3. Subject signed an Informed Consent for participation.
4. Subject diagnosed with a embolus/thrombus.
5. Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion Criteria:

1. Co-morbidity that in the discretion of the investigator might confound the results.
2. Subjects who are unable to read or write.
3. Pregnant or lactating women at time of enrollment
4. Subjects who are immune compromised
Acupuncture for the Treatment of Cancer Related Fatigue

Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy and/or radiation. Recently, methods to measure fatigue have improved - however, no non-medication interventions have been studied. Ameliorating fatigue may result in an improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure and has been used for many indications in pediatric patients. Adult studies have suggested improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose using acupuncture for the treatment in cancer-related fatigue in children and adolescents with central nervous system tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are ≥ 8 year of age and ≤ 21 years of age who are undergoing chemotherapy and/or radiation therapy for the treatment of any primary or recurrent central nervous system tumor (regardless of diagnosis or disease stage, whether it is malignant or benign, and in any location) at Children's Memorial Hospital.
* Patients who recently completed therapy (within 60 days of enrollment) will also be eligible. Patients must have a minimum baseline fatigue score of 15 on the pedsFACIT-F scale (Range 0-44). This is not a standard assessment for required clinical care and will only be administered by a research assistant to any patient after consent has been obtained. The assessment will be done during a routine clinic visit.
* For patients receiving cytotoxic chemotherapy with a history of myelosuppression or radiation, a hemoglobin concentration of \>8 g/dL measured within 10 days of enrollment and a platelet count of \> 30,000 within 5 days of enrollment is required.
* Patients must also be able to read and understand English and read a computer screen.
* Patients with no known contraindications to acupuncture therapy.
* Patients who are able to attend all scheduled visits for acupuncture.
* Patients must have a Karnofsky Performance Score of ≥ 50% or a Lansky Performance Score of ≥ 50.
* Patients who have provided informed consent for the research study (parental consent for patients \< 18 years of age). Patients between 12 years and 18 years of age must provide assent in additional to parental consents.

Exclusion Criteria:

* Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue.
* Patients who have received acupuncture in the previous six weeks.
* Patients with a life expectancy \< 3 months.
* Patients who are pregnant or lactating.
* Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas

The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
* Measurable disease sites on CT scan (\>1.5 cm in longest dimension)
* Adequate hematologic function:

  1. Absolute Neutrophil Count \>1500 cells/mm3
  2. Platelets \>50000 cells/mm3
  3. Hemoglobin \>8.0 g/dL
* Adequate hepatic and renal function:

  1. AST or ALT ≤2.5 x ULN
  2. Bilirubin ≤1.5 x ULN
  3. Estimated creatinine clearance (Cockcroft-Gault) \>40 mL/min
* ECOG 0 or 1

Exclusion Criteria:

* Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody
* Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
* Primary CNS lymphoma or evidence of CNS involvement by lymphoma
Levels of Visfatin/NAMPT in Human Milk

Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.

Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
* Maternal hospitalization
* Acquisition of the informed consent form signed by the patient

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Presence of hypogalactia or agalactia in the patient
Effects of Virtual Museum Visit on Pain, Fatigue, and Anxiety in Patients Receiving Chemotherapy

Symptom management is the most important aspect of clinical cancer care. Virtual reality-based interventions can be used to improve cancer patients' experiences with medical treatment, with their distraction-based effects. The aim of this study was to determine the effects of virtual museum visits with virtual reality glasses on pain, fatigue, and anxiety in patients receiving chemotherapy. The study included a museum visit with virtual reality glasses during the procedure in addition to routine treatments for patients in the intervention group. Patients in the control group were given only their routine treatments. Data will be collected using the Personal Information Form (PIF), Hirai Cancer Fatigue Scale, Visual Analog Scale (VAS) and Beck Anxiety Scale (BAÖ). In the first interview, the patient was also presented with virtual museum options and the museums he/she wanted to visit were listed. In addition, the patients in the Intervention Group were shown virtual museums with 53 different themes on the website prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, which is located on the website ''https://sanalmuze.gov.tr'' belonging to the Ministry of Culture and Tourism, and the museums they wanted to visit in each session according to their preferences were listed. In the meantime, the Intervention Group was explained how to use the virtual glasses and they will be tested. One week after the first test, the patients in the Intervention Group will visit a virtual museum on the theme preferred by the patients using virtual glasses for an average of 20 minutes for a total of five consecutive weeks. In the fifth virtual tour session, which is the third and last application session, measurements (Visual Analog Scale, Hirai Cancer Fatigue Scale and Beck Anxiety Scale) will be administered. The control group will not receive any intervention other than routine treatment.The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of the sample were having received at least one course of chemotherapy and continuing chemotherapy
* Having not visited a virtual museum with VR glasses before,
* Having no difficulty in communicating,
* Having no mental problems, being 18 years of age or older,
* Agreeing to participate in the study

Exclusion Criteria:

* The exclusion criteria of the sample were having not received chemotherapy or having completed treatment.
* Having Stage IV cancer
* Having difficulty seeing and communicating.
* Being under the age of 18
* The desire to withdraw from the study.