cyrilzakka/clinical-trials huggingface dataset:
Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

The goal of this single arm Phase I feasibility study is to investigate the tolerability of cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating side effects in this medically-ill population.

The purpose of this study is to determine the feasibility and the effects of cannabis with high concentrations of CBD in patients receiving chemoradiation for GBM. This is not a therapeutic study for the treatment of glioblastoma. Patients will first complete a cannabis sampling session to assess for initial marijuana tolerability. Proceeding this, patients will complete 3-5 outpatient smoking sessions per week over a 6 week period. During each session, patients will be given 90 minutes to smoke 0.5 to 2 cannabis cigarettes. Outcome measures will include measures of pain, mood, nausea, quality of life, and the both the potentially positive and negative subjective effects of cannabis. Food intake, opioid use, and compliance to cannabis treatment will be investigated. It is hypothesized that concurrent use of cannabis with chemoradiation in the treatment of patients with GBM will be feasible, well tolerated and may decrease radiation-induced toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 Gy of radiation given over 30 treatments
* Age 21-70
* Able to give informed consent, and comply with study procedures

Exclusion Criteria:

* Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis that could be exacerbated by the administration of cannabis
* Meet DSM-V criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis.
* Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
* Current (weekly) use of cannabis.
* Patients on supplemental oxygen or history of chronic obstructive pulmonary disease (COPD).
* Cardiovascular Disease
* Compromised Immunity
* Patients with a history of substance use disorder other than nicotine, such an opiate use disorder.
Comparison on the Efficacy of a Monophasic

The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.

The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.

This study will retrospectively collect and analyze clinical data related to the Atlanta VA Medical Center, a member of the National Registry of Cardiopulmonary Resuscitation, to assess clinical parameters in cardiac arrest survivors.

This study focuses on collecting data retrospectively in regard to cardiac arrest patients to discern what factors are playing a role in patient survival after cardiac arrest. Such data will help hospitals and physicians to improve quality of care in patients at risk for cardiac arrest as well as to implement strategies to reduce such events or improve management of these high-risk patients in order to save lives.

Eligibility Criteria:
Inclusion Criteria:

* Clinical outcomes of patients who suffered a cardiac arrest while hospitalized and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.

Exclusion Criteria:

Biphasic defibrillators were implemented Cardiac arrest before 2001
Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in which variables related to the percutaneous access closure for implanting devices at aorta level will be collected and analyzed.

The follow-up period will be 30 days after the procedure. The duration of the recruitment period will be one year. All data will be collected telematically and incorporated into a database for subsequent statistical analysis.

There will be 2 points for data interim analysis at 6 and 12 months after initiation of the study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old
* Signed informed consent
* Endovascular procedures on the aorta to any level, performed by percutaneous access and requiring the use of devices ≥ 10F
* Femoral Access suitable for percutaneous treatment in the opinion of the surgeon

Exclusion Criteria:

* Need for surgical repair of the femoral artery (stenosis aneurysmal)
* Initial indication of percutaneous closure with another device different from the Perclose Proglide
* Active infection of the puncture site
* Condition that prevents complete the 30 days follow up
Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions

Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized.

Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used.

Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction.

The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB.

For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.

Clinical care during and after the procedure will follow the existing guidelines.

Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years of age and older;
* Ability to provide free and informed consent before entering the study;
* Imaging diagnosis of a solid pancreatic lesion that was proposed for EUS characterization;
* Presence of sectional imaging method (CT/MRI) performed within six months before randomization;
* Blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers;
* Clinical indication by the endoscopist for EUS-tissue acquisition with the use of an FNB needle.

Exclusion Criteria:

* Failure to provide free and informed consent;
* Clinically significant change in haemostasis laboratory parameters: International Normalized Ratio (INR) \> 1.5; activated partial thromboplastin time (aPTT)\> 50 seconds; Platelets \<50,000;
* Absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of FNB;
* Absence of fasting (2h without clear liquids and 6h without solid foods);
* Clinical suspicion of upper digestive tract obstruction;
* An episode of acute pancreatitis within four weeks before echoendoscopy;
* Respiratory failure or hemodynamic instability;
* Pregnancy or breast-feeding.
Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
* Male or female outpatients, 18 years of age and older.
* Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and \< 200 mmHg at Study Visit 5 (randomization).
* Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Exclusion Criteria:

* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
* Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
* Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
* History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
* History or evidence of a secondary form of hypertension.
* Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
* Patients on 4 or more antihypertensive medications.
* Long QT syndrome or QTc \> 450 msec for males and \> 470 msec for females at screening.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Probioticson Bloating in IBS

The purpose of the study is to establish an in-vitro method to evaluate the effect of probiotics on gas production in feces (hydrogen and methane)

The objective of this study is to establish a model for screening probiotic bacteria in the treatment of meteorism symptoms (feeling of air in the stomach) with otherwise healthy adult women. As excessive bacterial gas production in the intestine is the most likely mechanism behind meteorism, we will examine eventual changes of the production of gases (hydrogen and methane) before and after administration of Trevis®. For screening of Trevis® we will apply a combination of clinical examination and a laboratory model for the determination of gastrointestinal gas production (a new method in connection with studies on probiotics). The results will be compared with the test person's specification of their health, both with respect to gastrointestinal function and in general through questionnaires. The background for the project will be described in the following.

Eligibility Criteria:
Inclusion Criteria:

- Female test persons with symptoms of meteorism, the age of \> 18 years, completely integrated in the Danish society (including nutrition), and no previous abdominal surgery besides from appendicectomy (advertisement in a local newspaper for test persons).

Exclusion Criteria:

* Lactose and sorbitol intolerant persons (based on hydrogen breath tests).
* Persons with chronic ingestion of medicine, that might have an effect on gut bacterial flora or bowel motility.
* Persons taking antibiotics within 2 month prior to the trial
* Persons with diagnosed gastrointestinal disease other than IBS.
* Persons not able to understand and/or read Danish.
* Persons under age and persons with obvious problems remembering and sticking to the protocol (persons with dementia, psychological illness etc.)
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
* Measurable disease based on RECIST v1.1.
* Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
* Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
* Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
* Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

* Disease that is suitable for local therapy administered with curative intent.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
* Known history of or is positive for active hepatitis B (hepatitis B surface antigen \[HBsAg\] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
* History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
* Use of protocol-defined prior/concomitant therapy.
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Eligibility Criteria:
Inclusion Criteria:

* All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

Exclusion Criteria:

* gestational age\<37 weeks,
* genital tract trauma,
* coagulation defect,
* women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
* known hypersensitivity to carbetocin or oxytocin.
Outcomes of a Novel Technique Minimal Scar Mastectomy

Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.


Eligibility Criteria:
Inclusion Criteria: breast cancer patients who opted for minimal scar mastectomy -

Exclusion Criteria: breast cancer patients who underwent conventional mastectomy

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Long Covid (Individuals with Ongoing COVID-19 Symptoms) Ongoing Effects

Persistent Covid-19 symptoms, known as long Covid, can impact healthcare provision. This study aimed to assess how symptoms persisting six months after Covid-19 affect quality of life and functional capacity.


Eligibility Criteria:
Inclusion Criteria:

* The study included individuals who had Covid-19 disease at least 6-18 months ago, who agreed to participate, and who were diagnosed with Covid-19 by a health institu-tion during the disease period.

Exclusion Criteria:

* Individuals who were not between the ages of 18-65, who had cognitive and commu-nicative impairments, and who had orthopedic and neurological limitations that would prevent them from performing physical activity were excluded from the study.
GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance

This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.

Breast cancer is the most frequent cancer for elderly women and represents the first mortality cause for them. Breast cancer incidence increases for elderly women and will become a major public health problem in the next years.

The principal therapeutic solution is the partial mastectomy associated to radiotherapy. However, the radiotherapy scheme and its role are debated for elderly patients. Hypo fractionated radiotherapy could be considered as an advantageous option.

The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are major cons. Thereby, for elderly patients, the selection of patients who will benefit from a shorter treatment could be really difficult. It would be interesting to define an objective scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays, onco geriatric evaluations are used to decide some treatment's decision, but no study compared different orientated radiotherapy schemes.

The present study proposes an onco geriatric evaluation leading to a score according to seven tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an adapted radiotherapy scheme.

Eligibility Criteria:
Inclusion Criteria:

* Woman more than 70 years old,
* Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.

Exclusion Criteria:

* Man,
* Patient with metastatic cancer,
* Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
* Patient under protection of justice or unable to give consent.
Periodontal Inflammation and Wound Healing in Multiple Extractions

Four participants requiring multiple dental extractions will be recruited for this study. Two participants will be 21-50 years old, two participants will be 65-80 years old. Following tooth extractions, soft tissue sampling will be completed from the extraction sockets at baseline, one week, two weeks and three weeks post-extraction. Soft tissue will be processed for sc-RNA sequencing and/or flow cytometry to determine what cells, genomic pathways are present at various timepoints during wound healing following dental extractions.

The purpose of this study is to better understand the cellular and immunological events occurring at various time points following dental tooth extractions as it relates to age of participants. Four participants requiring multiple extractions prior to denture fabrication will be enrolled: two will be younger than 50 years old, two will be older than 65. Inclusion criteria include: participants seeking multiple tooth extractions due to advanced bone loss or non-restorable teeth. Prior to tooth extraction, baseline clinical and radiographic data will be collected; including participant's height and weight, gingival crevicular fluid sampling (GCF), HbA1c reading, saliva sampling peripheral blood draw and smoking status. Routine, atraumatic extraction of the teeth under local anesthetic will be performed. Following extraction, a 3 mm x 3 mm soft tissue sample will be collected from one of the extraction sites and frozen/processed for sc-RNA sequencing and/or flow cytometry; the extraction sites will be sutured closed. The participants will return to clinic in one week's time for suture removal and soft tissue sampling of an adjacent previously unsampled extraction site under local anesthetic. The participants will return to clinic in another week's time (two weeks post-extraction) for a third soft tissue sample under local anesthetic from a previously unsampled extraction site. All soft tissue samples will be processed for scRNA sequencing and or flow cytometry. At all soft tissue sampling appointments, wound fluid will be collected from the extraction sites and processed for biomarkers via multiplex. Saliva samples will be frozen at time of sampling and will be frozen for multiplex evaluation. The single blood draw will be processes via sc-RNA sequencing and/or flow cytometry to assess presence of systemic immune cells. Final evaluation will be 3 months post-extraction and will include clinical (PD, BOP, CAL) and radiographic (CBCT) data collection. Statistical analyses will be completed to determine associations between various time points in the wound healing process and variables of interest (age, gender, etc), clinical measures, including body mass index (BMI) and outcomes (endotypes, measures of healing).

Eligibility Criteria:
Inclusion Criteria:

* requires multiple dental extractions
* aged 21-50, 65-80 years old

Exclusion Criteria:

* history of systemic inflammatory diseases or medications