cyrilzakka/clinical-trials huggingface dataset:
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients

Sleep disturbance is perhaps one of the most prevalent complaints of patients with long-standing painful conditions. Nabilone is a medication that is approved by Health Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to its sleep promoting properties, is sometimes prescribed by physicians to pain patients to help improve their sleep. However, there is no direct research evidence to either support or refute this practice. This study will investigate if nabilone is effective in improving sleep in insomnia and pain patients.

Rationale:

The current evidence suggests a sleep promoting effect of THC. Although, there is some support from pre-clinical and small sample size human studies suggesting a direct sleep enhancing effect, it remains unclear from the larger clinical trials, whether improved sleep is an epiphenomena secondary to improvements in the primary outcome measures ( i.e., pain, nausea or spasticity). There are no studies evaluating the sleep promoting effects of THC or analogues in patients with primary insomnia or objectively evaluating sleep at baseline and following treatment with THC or analogues in patients suffering from chronic pain disorder and insomnia. Cannabinoids have the potential of simultaneously improving sleep and lessening chronic, non-malignant pain, thereby interrupting the vicious cycle of pain and sleep disturbance. An investigation of the efficacy of cannabinoids in treating insomnia in chronic, non-malignant pain patients is therefore warranted.

Research Question:

To evaluate if nabilone (Cesamet) is effective in improving sleep in patients with insomnia and chronic, non-malignant pain

Eligibility Criteria:
Inclusion Criteria

* History of insomnia and chronic, non-malignant pain.
* Patient not currently being prescribed opiates for pain management
* Subject has no known clinically significant abnormal vital signs or other significant clinical findings at screening.

Exclusion criteria

* Patients with a history of sensitivity of cannabinoids.
* Patients currently taking hypnotics, psychotomimetic substances, CNS depressants or tricyclic antidepressants that may increase the CNS-depressant effects of nabilone.
* Patients with active cardiac disease or respiratory disorders.
* Patients with a history of psychotic reactions, schizophrenia, bipolar disorder or any serious untreated mental disorder.
* Presence of untreated sleep disorder (other than insomnia) as detected using the screening overnight PSG.
* Alcohol or substance abuse (according to DSM-IV) during the last 6 months prior to baseline.
* Patients with liver disease that may interfere with the clearance of nabilone.
* Patients who are nursing, pregnant or likely to become pregnant throughout the course of the study. During the study, female patients will be asked to use an effective method of birth control.
Effect of Pilates Exercises on Gross Motor Function and Balance

the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children


Eligibility Criteria:
Inclusion Criteria:

* 7 to 9 years,
* mild spasticity of lower limb
* able to understand and follow instructions

Exclusion Criteria:

* fixed contracture
* visual or respiratory disorders,
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis

Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.

Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years to75 years
* Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13
* Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).

Exclusion Criteria:

* Hepatocellular Carcinoma
* Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.
* Any organ failure
* Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement
* HIV seropositivity
* Pregnancy
* Refusal to participate in the study
* Previous known hypersensitivity to G-CSF
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 seropositive
2. Have a history of at least 6 months on antiretroviral treatment
3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion Criteria:

1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST \> 4 x upper limit of normal (ULN)
2. Females who are pregnant
3. Any vaccination within 2 weeks prior to the Screening
4. Any prior exposure to UB-421
Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.

Exclusion Criteria:

* any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding
Comparison of Preparation Regimens for Colonoscopy

The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing colonoscopy

Exclusion Criteria:

* patient refusal to sign informed consent
A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection

This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection


Eligibility Criteria:
Case Inclusion Criteria:

1. Subject who was diagnosed as thoracic aortic aneurysm/dissection by CT angiography, interventional angiography or vascular ultrasound;
2. Age is less than 80 years old;
3. male and non pregnancy female;
4. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.

Case Exclusion Criteria:

Subject has one of the following:

1. Pseudoaneurysm;
2. Previous infection or trauma in the damaged part of aorta;
3. Pregnancy female;
4. Participate in other clinical trials in the last 1 months.

Control Inclusion Criteria:

1. Age and gender are matched with cases;
2. No aortic disease was detected by outpatient ultrasound;
3. No family history of cardiovascular disease;
4. Normal biochemical indicators;

Criteria for culling, shedding and suspension testing:

1. Culling: Unqualified cases and controls. Data of culled subjects can not be used for statistical analysis;
2. Shedding: Subject that self withdrawal, loss to follow-up, or quitted by doctors; Reasons for shedding should be indicated for each shed subject.
3. Suspension: a) The researchers found significant safety problems or wrong study design; b) Researchers cannot continue clinical research due to funding or management reasons; c) Director ends the study. When suspension happens, all the CRF table should be reserved for future reference.
Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study

Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe OSA defined as Apnea Hypopnea Index (AHI) \> 30.
2. Age \> 18 years.

Exclusion Criteria:

1. Previous history of clinical AF defined as documented lone, paroxysmal, persistent or permanent, according to standard definitions.
2. Patient with anticipated requirement of MRI.
3. Patient with well-know allergy to any component of the Medtronic Reveal XT.
4. Patients with implantable cardiac rhythm device \[pacemakers or internal cardiac device (ICDs)\].
5. Women of child bearing potential.
6. Unable or unwilling to provide written informed consent.
7. Unable or unwilling to complete the study follow-up schedule (eg. intention to leave the Kingston area over the next 3 years.
8. Previously enrolled in this trial.
9. Enrolled in another study that would confound the results of this trial.
10. Documented history of heart failure
11. Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children

This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for reversal of neuromuscular blockade, aged between 2 and 18 years old.

After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

On reappearance of T2 after rocuronium administration , 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.

For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.

Eligibility Criteria:
Inclusion Criteria:

* All of below Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade Aged between 2 and 17 American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria:

* Any of below One or more legal guardian declines to enroll in the study History of hypersensitivity to any anesthetic agents including rocuronium Presence of underlying cardiovascular or genitourinary disease Under usage of neuromuscular blocking agents before surgery Under usage of drugs influencing the effect of neuromuscular blocking agents History of malignant hyperthermia Anticipation of massive hemorrhage during surgery
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol

Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.

Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 50 years old.
* Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.
* Positive parasitological diagnosis for cutaneous leishmaniasis.
* Patients that voluntarily accept to participate in the study and sign the informed consent.
* Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).
* Acceptation of not using any other treatment for cutaneous leishmaniasis while in the study.

Exclusion Criteria:

* Pregnant women.
* Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.
* Diffuse cutaneous leishmaniasis.
* Visceral leishmaniasis.
* Complete or incomplete treatment with antimony compounds in the last three months.
* Patients with history of hepatic, renal, or cardiovascular disease.
* Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
Animal-assisted Therapy Improves Cognitive and Emotion in Nursing Home Residents

More than 80% of the residents of the investigator's nursing home are dementia, who are often mentally and emotionally unstable. The staff need to spend time helping to eliminate problems. The investigator assume that non-drug intervention measures can be added, such as the Animal-assisted Therapy (AAT). The hypothesis for ATT is expected to improve the mental and emotional inappropriate manifestations of dementia, reduce interfering behaviors, improve the quality of life, reduce the use of inappropriate mental drugs, and expect residents to delay the degradation of physiological functions.

Nursing homes in the investigator's country accept dementia residents usually. The dementia residents often suffer from mental and emotional problems. Then they used drugs to improve the mental and emotional conditions. There were many studies about non-drug treatments ,such as: gardening, nostalgia, pets, and other interventions were improved for the mental and emotional to dementia residents.Well-trained therapy dogs exhibit the behavior that human patients construe as friendly and welcoming.AAT dogs are also required to possess a calm temperament for accommodating the contact with unfamiliar clients while they serve as a source of comfort. In domestic observational studies, non-pharmaceutical interventions for people with dementia who have activities and the hypothesis for ATT can improve the quality of care for dementia, reduce the use of mentally inappropriate drugs, and delay the degree of degeneration. Recent evidence has shown that nursing institutions with dementia arranged weekly activities with AAT for a period of 6 months. Significant improvement was in social interaction, emotional expression, and behavioral and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Residents of long-term care homes
* No fear or allergy to dogs
* Wheelchair accessible persons
* Able to communicate in Mandarin and Taiwanese
* Agree to sign the subject consent form

Exclusion Criteria:

* Non-residents of nursing homes
* Fear and allergy to dogs
* Bedridden and wheelchair users
* Do not agree to sign the subject consent form

Note: Although many nursing home residents have symptoms of dementia, many have not been diagnosed by a doctor, so dementia and other related diseases cannot be included in the inclusion or exclusion criteria.
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification

Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes.

The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time.

This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old
* suffering from systemic lupus erythematosus.

Exclusion Criteria:

underlying diseases that can lead to bone and cardiovascular metabolic disturbances :

* Malignancies such as cancer metastasized
* Autoimmune disease other than LED or of overlap syndrome ( rhupus , MCTD )
* Infection by HIV, hepatitis B and C
* Hepatic Cirrhosis
* Chronic renal failure
* Parathyroid disorders
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
* High-risk or unfavorable intermediate-risk as defined below:

High-risk localized prostate cancer, as defined by any one of the following factors:

Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher.

Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors:

Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and \>50% biopsy cores positive, or The presence of any two of the following: PSA\>10, cT2b-c, Gleason score 3+4 in any core

* No pelvic nodal metastases (based on CT or MRI findings)
* No distant metastases, based upon:

CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis

* Age ≥ 18
* KPS ≥ 70 (or ECOG 0-2)
* Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

* Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option)
* Patients with any evidence of distant metastases
* Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration
* Prior cryosurgery, HIFU or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohn's Disease or Ulcerative Colitis
International Registry of Coronavirus (COVID-19) Exposure in Pregnancy

The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.

The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.

Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women or women who have been pregnant within the last 6 months
* Able to give electronic informed consent
* Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional

Exclusion Criteria:

* \<18 years of age