cyrilzakka/clinical-trials huggingface dataset:
Analgesic Efficacy of Smoked Cannabis

The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.

It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. There are limited clinical studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that 20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).

Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Male or Female
* Subject smoked cannabis within the last six months

Exclusion Criteria:

* Active opportunistic infections or opportunistic malignancies requiring acute treatment
* Active substance abuse (alcohol or injection drug)
* Pulmonary complications (e.g., tuberculosis, asthma)
* Current use of cannabis (e.g., within 30 days of randomization)
* Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
* Personal or familial history of psychiatric disorder
Acupuncture for Fatigue in Parkinson's Disease

This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PD
* Patients 40-99 years of age
* Patients who have significant fatigue
* Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

* Patients who have had previous acupuncture within the past six months
* Patients who have had deep brain stimulation (DBS)
* Patients with dementia, depression, or sleep disorder
* Patients who are currently taking medications known to affect fatigue, such as stimulants
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.

Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient
2. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.
3. Age \>18-50 years old
4. Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).
5. No antidepressant treatment for at least 8 weeks prior to randomization.
6. PANSS Negative subscore \>14 with at least two of the items at a level \>/=4 (moderate)
7. PANSS Positive subscore \</=14 with not more than one of the items at a level \>/=4 (moderate)
8. Hamilton Depression Rating Scale (HAMD-17) total score \</=12
9. Simpson Angus Score of any item \<2
10. Behaviorally Anchored Rating Scale (BARS) of any item \</= 1
11. Competent and willing to sign informed consent
12. The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception

Exclusion Criteria:

1. Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
2. Structural brain disease (based on previous medical records)
3. Cognitive disability by history and estimated intelligence quotient (IQ) \<70 (ID DSM-5 diagnosis).
4. Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
5. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
6. Any current diagnosis of substance abuse or dependence.
7. Serious risk of suicide.
8. Patients with thyroid conditions.
9. Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
10. Pregnant or breastfeeding female.
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction

The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.

The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.

This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* arthralgia of one or both temporomandibular joints
* Wilkes II to IV internal derangement of the symptomatic joint OR
* limited opening of \<35 mm

Exclusion Criteria:

* myofascial pain as the primary source of pain

  * cervical pain as the primary source of pain
* systemic arthropathy
* fibromyalgia
* use of NSAIDS within 48 hours
* allergy to study medications
* edentulous subjects
* pregnancy or breast feeding
* current physical therapy, muscle relaxants or antiseizure medications
* current use of a splint issued within last 12 weeks
Pylorus Distensibility Measurement

The present study aims at characterizing the pylorus functionality in overweight and obese patients (BMI 27-40) using a systematic measurement approach by using an impedance planimetry technology.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged between 20 and 60 years inclusive
2. A BMI between 27.0 and 40.0 kg/m2
3. Willing and able to provide written informed consent
4. Willing and able to comply with the study procedures
Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV

Life stress is strongly associated with poor mental and physical health and its effects explain significant morbidity and mortality. Forgiveness is one of the factors that can influence the effects of stress on health. By definition, forgiveness is the release of negative feelings, emotions, and behaviors - and possibly the release of positive feelings - toward an offender. Numerous studies have shown that forgiveness is associated with several mental and physical health benefits. The literature argues that high levels of propensity to forgive (trait) predispose that person to experience forgiveness (state) more often. In other words, a stronger forgiving disposition is believed to increase the experience of forgiveness, which, in turn, mitigates the negative effects of stress. Forgiveness is therefore a coping style that can play a beneficial role in the stress-health relationship. Patients living with HIV (PLHIV) are patients particularly exposed to stress, not only because of their chronic pathology but also because of the stigma attached to this disease. Very few studies have studied the impact of forgiveness (state or trait) on the physical health of PLHIV and even fewer the impact of an intervention promoting the disposition to forgive. The objective of this prospective observational monocentric study is to show in a very secular country that forgiveness has an effect on well-being as well as on other health parameters.


Eligibility Criteria:
Inclusion Criteria:

* Belonging to the PLHIV followed at the Amiens University Hospital, not likely to move within the year
* Possibility of follow-up in teleconsultation (usual support of the service)
* Benefiting from a social security scheme
* Consent to participate in the research

Exclusion Criteria:

* Erratic follow-up (non-compliance, predictable move) or moribund patient
* Illiterate or not speaking french
Generalization of Training in Schizophrenia

This study examines whether patients with schizophrenia can benefit from a problem-solving training intervention and whether a work-related social skills training intervention leads to improvements in the patient's performance at work.


Eligibility Criteria:
Inclusion Criteria:

* Veterans with schizophrenia or schizoaffective disorder
Population Pharmacokinetics of Ropivacaine

The aim of this study was to investigate the pharmacokinetics of free and total ropivacaine after unilateral and bilateral TKA. A population model was successfully built and peak free ropivacaine concentration stayed below previously proposed toxic thresholds in patients undergoing unilateral as well as bilateral TKA receiving LIA with high dose ropivacaine.

Thirteen unilateral TKA and fifteen bilateral TKA patients were included in the study. All patients were operated in a well-described fast-track setup without use of drains or tourniquet.21 A standard midline skin incision with a medial para-patellar capsulotomy was used. All patients were operated with cemented CR components. In bilateral TKA cases, both knees were operated in one setting with the left knee always being operated first, and the second knee being operated sequentially in the same setting immediately following closure of the first knee. Patients undergoing unilateral TKA received spinal anesthesia with 2 mL 0.5% hyperbaric bupivacaine, whereas patients scheduled for bilateral TKA received spinal anaesthesia with 3 mL 0.5% hyperbaric bupivacaine. Local infiltration anesthesia was performed as previously described with 200 mL 0.2% ropivacaine (400 mg) mixed with 1 mL 1 mg/mL epinephrine injected periarticularly in each knee. The first 50 mL were injected into the posterior capsule, 100 mL were injected into medial, anterior and lateral structures of the knee and capsule and the final 50 mL were injected in the subcutaneous tissue. All patients were mobilized on the day of surgery and thromboembolic prophylaxis started 6-8 hours postoperatively with rivaroxaban tablets (10 mg) given once daily until discharge. No extended thromboembolic prophylaxis was given to any patient. All patient received 1 g intravenous tranexamic acid preoperatively and 1 g 3 hours postoperatively.

Preoperative blood samples were taken within a week of surgery including electrolytes, hemoglobin and serum creatinine levels. Baseline blood sample was taken just before incision of the first knee, and additional blood samples were drawn at 1, 5, 30 and 60 minutes as well as 2, 4, 8 and 24 hours after incision following unilateral TKA and at 1, 5, 30 minutes after the incision of the first knee and 0, 5 and 15 minutes after incision of the second knee as well as after 1,2, 4 8 and 24 hours (total 9 and 12 timepoints within 24 hours for unilateral and bilateral TKA, respectively). Patient demographics were recorded and included age, gender, height and weight.

Ropivacaine measurement Ropivacaine concentrations were determined in plasma samples using liquid-chromatography coupled to mass spectrometry following a fully validated method

Eligibility Criteria:
Inclusion criteria:

Patients undergoing unilateral TKA (n=13) and bilateral TKA (n=15) receiving LIA according to standard protocol.

Exclusion criteria:

Patients not receiving LIA Revision TKA
Sepsis in Geriatric Patients With Suspected Infection.

Sepsis is a complex clinical syndrome that has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. It is more frequent and severe in older subjects, at least in part because of delayed diagnosis and treatment due to low clinical suspicion and atypical manifestation.

The Sepsis-III consensus proposed the easy to use bedside clinical score quick Sequential Organ Failure Assessment (qSOFA) to identify patients at risk for sepsis and death outside intensive care units. However, some Authors have disputed this recommendation, proposting the use of other more complex bedside tools such as the National and Modified Early Warning Scores (NEWS and MEWS, respectively) for the same purpose.

Published studies on these scores included generally younger, selected subjects, not fully representative of the population at risk for sepsis.

In the present study we aimed to evaluate the incidence of sepsis in older subjects with suspected infection in a geriatric acute ward setting, to determine and compare the accuracies of qSOFA, NEWS and MEWS to identify sepsis and to investigate factors associated with in-hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in the Acute Geriatric Unit
* Presence of at least one National Institute for Health and Care Excellence (NICE) guidance risk factor for sepsis (i.e. age ≥75 years, impaired immune function - diabetes mellitus, previous splenectomy, hematologic diseases - long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures in the previous 6 weeks, any breach of skin integrity - e.g. pressure ulcers - intravenous drug misuse, indwelling lines or catheters)

Exclusion Criteria:

* Refusal to give written informed consent
Persistent Pain After CS Delivery

Many factors influence the development of persistent pain after CS (chronic pain) as well as post-partum depression. We are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. Assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. Physical activity is monitored by subject's wearing a Fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..

Subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive screening questionnaire. Pain treatments/satisfaction assessments are captured for the first 24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible subjects for 60 days post-delivery.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age English speaking

Exclusion Criteria:

non-English speaking
PFN-A Augmentation for Intertrochanteric Femoral Fractures

This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.

The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
* Healthy contralateral hip
* ASA (American Society of Anesthesiologists) Physical Status Class I or II

Exclusion Criteria:

* Dementia
Hunger and Learning Study in Preschoolers

This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. Data are collected at the Diet and Nutrition (DAN) laboratory on repeated study days (8am - 4 pm).

The investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. If preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. This study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch).

An important secondary outcome related to children's feelings of hunger is their ability to learn. Currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. This study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (Kranz S.et al. "High-Protein and High-Dietary-Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast" J Nutr doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (HTKS, KRISP, Stroop-style tasks, Woodcock Johnson vocabulary test, DCCS, and curisoty measures.)

Eligibility Criteria:
Inclusion Criteria:

* healthy children

Exclusion Criteria:

* no food allergies
* no medications that affect behavior/learning/appetite
Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.


Eligibility Criteria:
Inclusion Criteria:

* Ferritin \<15 µg/L
* Hb 8-11.9 g/dl
* BMI 18.5-24.9 kg/m2
* Body weight \<70 kg

Exclusion Criteria:

* Severe anemia (Hb \<8 g/dl)
* Elevated CRP \>5.0 mg/L
* Chronic disease
* Long-term medication, except contraception
* Consumption of Mineral and Vitamin supplements within the study period
* Therapeutic iron infusion over the past 6 months
* Pregnancy or breastfeeding
* Smoking
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, at the time of acquisition of informed consent
* Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
* Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations
* imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2
Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Has dry eye symptoms (minimum 3 months)
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
* The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
* Intraocular pressure(IOP)\> 21 mmHg
* Patients with contact lens
Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion Criteria:

* contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants

The researchers want to determine if ambient light, plethysmographic , can monitor reliably heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.

The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window. Heart rate and oxygen saturation will be extracted from the plethysmographic signal off the cheek, forehead or hand while the respiration rate may be retrieved from the plethysmographic signal off the chest area.

Eligibility Criteria:
Inclusion Criteria:

* infant in NICU at CHOC hospital

Exclusion Criteria:

* non-infant