cyrilzakka/clinical-trials huggingface dataset:
Outcomes Mandate National Integration With Cannabis as Medicine

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Medical cannabis has been legal in parts of the USA since 1996, with the stated intention of reducing pain (both acute and chronic) as well as for treatment of multiple other conditions. The original implementation of medical cannabis in the USA was implemented in California as a compassionate measure to treat the HIV/AIDS epidemic. Additional studies have shown promising outcome for patients with multiple sclerosis, seizures, cancer, and other chronic conditions. However, there have been few comprehensive studies that have actually measured whether cannabis is an effective treatment for pain reduction. There is an absence of multistate, multicenter clinical studies with cannabis as medicine, not only in the USA but globally. With the expansion of medical cannabis into more than 38 states in the US, this type of clinical study is now feasible.

On March 11, 2020, the World Health Organization formally characterized coronavirus, COVID-19, as a global pandemic and health systems globally are continuing their efforts to manage the outbreak. Coronavirus disease COVID-19 is an infectious disease caused by a newly discovered coronavirus. With the rapidly growing pandemic of COVID-19 caused by the new and challenging to treat zoonotic SARS-CoV2 coronavirus, there is an urgent need for new therapies and prevention strategies that can help curtail disease spread and reduce mortality. Inhibition of viral entry and thereby spread constitute plausible therapeutic avenues.

This study will utilize an anonymous novel online questionnaire to determine study participants' qualifying condition(s) for medical cannabis use, cannabis ingestion method, frequency of use, prescription drug use, and demographic information. Secondary factors will include evaluation of pain control, quality of life metrics, any adverse side effects from cannabis use, as well as changes in adjunctive treatments. Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a Qualifying Condition for Medical Marijuana
* Must be 18 years or older unless they have consent from their parent or legal guardian as defined under state law parameters
* Must be willing to complete online surveys at baseline and the follow up points in this study

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Inability to provide informed consent
* Inability to complete study visits or questionnaires
* Active suicidality or psychosis, that could be exacerbated by the administration of cannabis
Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS)

The objective of this study is to compare the effects of two intraoperative fluid regimens - restrictive versus liberal (standard)- on postoperative outcomes (e.g. cardiopulmonary complications, morbidity, mortality and duration of hospitalization) in lung resections via Video-assisted thoracic surgery (VATS).

Working hypothesis and aims:

The aim of this study is to investigate the effect of restrictive versus standard intraoperative fluid regimen on cardiopulmonary mordibity and mortality after VATS for lung resection. Our study hypothesis is that restrictive intraoperative fluid administration in patients undergoing VATS, will lead to better outcomes compared to a liberal fluid regimen.

Methods:

After obtaining informed consent, patients will be randomly assigned to one of two groups-liberal-protocol group (LG) or restricted-protocol group (RG). Anesthetic and surgical management will be performed similarly and according to standards for both groups, with one exception: patients in the RG group will receive 2 ml/kg•hr whereas patients in the RL group will receive 8 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period. Hemodynamic changes during this period will be treated pharmacologically unless indicated otherwise. Blood loss, in both groups, will be replaced with RL solution in a 3:1 volume replacement, and blood and/or blood products will be transfused when required. Postoperatively, pain and fluid management will be standardized for both groups, according to departmental routines. Patient assessment will be performed by a blinded assessor. The primary endpoints of the study will combine: the incidence of post-operative complications (pulmonary, cardiovascular, others), re-intubations, and readmitions to the ICU during primary hospitalization; number of patients readmitted to the hospital within 30 days of surgery.

The secondary endpoints will include length of hospital stay, differences in hematocrit, urea, creatinine concentrations and oxygen saturation immediately postoperatively, in the first and third postoperative days and with discharge, and the number of patients receiving transfusion of blood and blood products; time to extubation, time to sit/stand/walk/eat/drink (recovery data).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old, with ASA I-III, undergoing elective VATS for lobectomy (of at least 2 segments), segmentectomy or pneumonectomy in the Sourasky Medical Center.

Exclusion Criteria:

* Patients with a history of chronic renal insufficiency (creatinine \> 1.5 of normal value), congestive heart failure or hepatic dysfunction.
Comparison of Craniosacral Therapy and Myofacial Relaxation Techniques in People Diagnosed With Migraine

Headache is a neurological condition that is very common all over the world and is observed at some time in life in more than 90% of society. Migraine headache, known for thousands of years, is one of the oldest diseases of humanity. The word 'hemicrania', meaning 'half of a head', is used due to unilateral pain. Approaches to treating migraine include medication, relaxation, biofeedback, living a regular life, adequate sleep, exercise, and stress management. Neck pain is especially common in migraine patients. Exercise, manual practices, electrop novelties are used to reduce musculoskeletal problems, thus reducing the effects of migraine. Myofascial relaxation techniques, which are included in the manipulative techniques in the literature, are relaxation methods performed on myofascial trigger points.Osteopathic manual therapy (OMT) , which has recently entered the literature, 19. osteopathy, developed by Andrew Taylor STILL at the end of the century, is a treatment system characterized by focusing on integrity and using it by hand to heal diseases.The study of cranial OMM kraniyum first anatomical and physiological mechanisms for the prevention and treatment of disease as a whole is concerned with the relationship of the body, including diagnostic and therapeutic methods.It is used in the treatment of somatic dysfunction of the head and other body parts. An important component of cranial Omm is the primary respiratory mechanism, which occurs as movement of the head bones, sacrum, dural membranes, central nervous system and cerebrospinal fluid. The primary respiratory mechanism is synchronous with the cranial rhythmic impulse, a 2-phase rhythmic cycle that represents a dynamic metabolic exchange with each stage of the body. This cycle is indicated as loops between 7 and 14 per minute.Fascial mobilization therapy increases energy use in segments implemented by mechanical changes.Accordingly, it helps to reduce the spasm of these layers extending fascially, to dissolve adhesions, and to increase the range of motion of the joint.

H0: Osteopathic Manipulative Therapy has no effect on migraine symptoms. H1: Osteopathic Manipulative Therapy has an effect on migraine symptoms. H2: myofascial relaxation techniques have no effect on migraine symptoms. H3: methods of Osteopathic Manipulative Therapy have an effect on migraine symptoms.

H4: myofascial relaxation techniques and osteopathic manipulative treatment methods have no superiority over each other.

H5: myofascial relaxation techniques and osteopathic manipulative treatment methods have superiority over each other.


Eligibility Criteria:
Inclusion Criteria:

Age 18-65 Diagnosed with chronic migraine Patients who have recently been diagnosed with chronic migraine who have not taken any medications so far for migraines.

Exclusion Criteria:

Those in the drug group had a decommissioning of drug use for 4 weeks Suspicion or presence of pregnancy
Overactive Bladder Education

Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence.

Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction.

This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed "Overactive Bladder Plan of Care" information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician.

At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge.

Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of overactive bladder
* able and willing to participate and consent
* age \>17 years, \<90 years
* female sex

Exclusion Criteria:

* male sex
* patients who do not have a diagnosis of overactive bladder
* age \<18 years, \>89 years
* unable or unwilling to participate
* patients who are already being treated for overactive bladder
* patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder
* patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder
* pregnancy
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.

OBJECTIVES:

* Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer.
* Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.

OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV).

Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.

Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy.

Hormonal therapy is administered until 9 months of treatment have elapsed.

Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven localized adenocarcinoma of the prostate

  * Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4
  * CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50
  * Negative pelvic lymphadenectomy, if PSA is greater than 50
  * Bone scan negative for metastases or PSA no greater than 20

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance Status:

* Not specified

Life Expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm3
* Platelet count at least 70,000/mm3
* Hemoglobin at least 10 g/dL
* Patients on anticoagulant therapy must have a baseline PT test

Hepatic:

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* ALT or AST less than 1.5 times ULN
* Alkaline phosphatase less than 1.5 times ULN

Renal:

* Creatinine less than 1.5 times ULN

Cardiovascular:

* No history of collagen vascular disease

Other:

* No acute infection requiring antibiotics
* No history of hypersensitivity to flutamide
* No history of hypersensitivity to leuprolide acetate

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

Dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. However, regeneration of functional dental pulp has proved difficult. Therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.

This study is a single-center, prospective, single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. All participants in this study will receive stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers after the preparation and disinfection of the root canal of the affected teeth. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 45 years
* Patients with pulp necrosis of a single canal permanent tooth due to trauma or caries
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc
* Patients with calcification of the apical foramen at the root of the tooth
* History of hereditary disorders of abnormal tooth development
* Dental occlusal trauma, bruxism, malocclusion
* Bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.)
* Presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity)
* Malnutrition (serum albumin concentration\<2 g/dl)
* Patients with history of other systemic, communicable or hereditary diseases have been diagnosed
* Pregnant, nursing, planning to become pregnant
* The investigators determined that the patient was not suitable for the study
Protein, Sarcopenic Obesity, and COPD

Both sarcopenic obesity and chronic obstructive pulmonary diseases (COPD) are common conditions that mainly affect middle-aged and older adults. Previous research has shown that increased dietary intake of total and plant-based protein is associated with a lower risk of sarcopenic obesity, using data from the EPIC Norfolk study. Furthermore, a systematic review and meta-analysis showed that having sarcopenic obesity was associated with significantly impaired lung function outcomes. Other research has shown that increased intake of dietary protein leads to a better treatment outcome for respiratory diseases. The aim of this pilot observational study is to investigate, in more detail, the relationship between the quantity and source of dietary protein intake, the prevalence of sarcopenic obesity, and lung function, in a small cohort of older female participants with COPD. The study will also consider the role of inflammation in relation to sarcopenic obesity and lung function outcomes. This study will help to improve the understanding of the relationship between sarcopenic obesity and lung function outcomes, and how dietary protein intake and inflammation can affect this relationship and each of the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Women.
* Clinically diagnosed with COPD.
* Aged 55 years or older.

Exclusion Criteria:

* Male.
* Women who are 54 years or younger.
* Those who have dementia.
* Unable to read or write in English.
* Unable to attend the Human Intervention Studies Unit.
* Those within one year life expectancy.
* Those who have cancer.
Use of a TGA and TEM in the Assessment of the Efficacy of Treatment With APCC or rFVIIa

Occurrence of inhibitors to coagulation factor VIII is diagnosed in \~30% patients with haemophilia A. Presence of inhibitor with a titre \>5 BU/ml requires the use of by-passing agents: recombinant activated Factor VIIa concentrate (rFVIIa) and/or activated prothrombin complex concentrate (APCC). Similarly, haemorrhagic complications in patients with acquired haemophilia and inhibitor titre \>5 BU/ml should be treated with by-passing agents.

Response to treatment with by-passing agents is patient-specific, and can vary in the same patient during subsequent bleedings. Some patients have good response to both products, however in other patients a better bleeding control is provided by one of the mentioned above agents (APCC or rFVIIa). There are clinical situations when severe bleedings requires an alternate use of both these agents.

Traditional methods of laboratory tests used post-treatment in patients with haemophilia without inhibitors are useless in the presence of inhibitor. Laboratory monitoring of therapy with by-passing agents is possible with the use of global tests for the coagulation process assessment, which are as follows: thrombin generation assay (TGA) and thromboelastometry (TEM).

Several studies revealed that TGA allows a monitoring of therapy with by-passing agents in patients with haemophilia A and inhibitor - the choice of the most effective treatment option - agent type and its dose, as well as laboratory assessment of treatment efficacy.

Up to date, laboratory tests assessing the efficacy of by-passing agents in patients with acquired haemophilia were not conducted.

In Factor VIII or IX deficiency conditions, fibrin's fibres generated by thrombin are morphologically thicker, and blood clots have increased susceptibility to fibrinolytic enzymes. Blood clot stability may be assessed with the use of thromboelastometry (TEM). We can hypothesize that simultaneous use of TGA and TEM methods may allow for an assessment of patient's individual response to therapy with by-passing agents. Clinical significance of the minimal dose of APCC and rFVIIa, needed to TGA and TEM normalization, requires further studies.

Tests' purpose: Examination of the hypothesis that simultaneous use of thrombin generation assay (TGA) and thromboelastometry (TEM) may facilitate the choice of optimal therapy with by-passing agents and laboratory monitoring of efficacy of those agents in patients with acquired haemophilia or haemophilia A with inhibitor.

This section is Not applicable

Eligibility Criteria:
Inclusion Criteria:

* patients with acquired haemophilia
* patients with congenital haemophilia A with inhibitor

Exclusion Criteria: