cyrilzakka/clinical-trials huggingface dataset:
Opioid Agonist and Antagonist Effects on Opioid Dependence

The purpose of this study is to examine the acute agonist and antagonist effects of a full opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist medication in individuals who have different levels of physical opioid dependence.

The pharmacological effects of opioids in opioid dependent individuals can vary as a function of the characteristics of the opioid being studied (e.g., whether it is an agonist, partial agonist, or antagonist; the dose administered; and the route of administration). Another important set of factors influencing the effects produced by opioids is the characteristics of the organism to which the opioid is being administered. One such characteristic is the level of physical dependence in individuals.

Participants in this study will be maintained on different dose levels of an opioid agonist (methadone). The participant will be challenged with a prototypic opioid agonist, antagonist, and a mixed agonist-antagonist with partial agonist features in order to determine the effects that each has on the human body.

Eligibility Criteria:
Inclusion Criteria:

* Active opioid dependence
* Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine)
* Fulfills DSM-IV diagnostic criteria for opioid dependence

Exclusion Criteria:

* Significant medical problems, including insulin dependent diabetes mellitus
* Non-substance use psychiatric disorders (e.g., schizophrenia)
* Currently seeking treatment for substance abuse
Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis

Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.

This was a randomized controlled trial in patient with single-level low grade degenerative lumbar spondylolisthesis with failed conservatives treatment, by comparing two group of surgical intervention between Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) and Endoscopic lumbar decompression using functional outcomes.

The participants were randomized into two groups with 33 cases each group (Total = 66) by using computer generated program with block of four randomization with allocation ratio 1:1. The control group received conventional treatment which is Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion while the experimental group received endoscopic lumbar decompression. Using ODI score as primary outcome. Data were analyzed using chi-square test for categorical data (eg, sex, symptoms of weakness and numbness, level of spondylolisthesis) and unpaired T-test for continuous data (eg. VAS score, ODI, slippage percentage, lumbar lordosis degree, slip angle, op time) which considered significant difference of the outcomes when p \< 0.05 with a power of 80%. Consider endoscopic decompression is non-inferiority to MIS-TLIF when upper limit of the one-sided 95%CI for the differences in ODI means is less than margin (12.8 points) If the results show that endoscopic decompression is non-inferiority to MIS TLIF, endoscopic lumbar decompression may be a choice of treatments giving benefit of minimal invasive surgery and avoid interbody fusion complication such as pseudoarthrosis, adjacent problems and operative blood loss

Eligibility Criteria:
Inclusion Criteria:

* Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).
* Failed conservative treatment for at least 3 months.
* No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).
* Able to follow up for at least 12 months.
* Patient who vorantarily agree to participate in research.

Exclusion Criteria:

* Patients with severe foraminal stenosis diagnosed by MRI.
* Patients who have previously undergone lumbar spine surgery (revision surgery).
* Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.
* Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.
To Study the Mechanisms of Acupuncture Through Functional Magnetic Resonance Imaging and Peripheral Neurosensory Testing

Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both the peripheral and the central nerve systems


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* Male and female
* No acupuncture treatment for the past 2 weeks
* No analgesics for the past 2 weeks
* Absence of neuropathic pain states

Exclusion Criteria:

* History of psychological illness
* History of Claustrophobia
* Lack of ability to understand the experimental protocol and to adequately communicate in English
* Pregnancy
* Pending litigation
* History of head trauma
* History of trauma or surgery to lower extremities and pelvic area
Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

The aim of this study is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation.

The female breast is one of the most attractive aesthetic areas in female anatomy. The size, shape, and symmetry of the breasts can have a dramatic effect on the women's wellbeing. Reduction mammaplasty is certainly one of the operations; plastic surgeons can significantly contribute to a woman's quality of life.

Macromastia or Breast Hypertrophy is a pathologic condition consisting of hypertrophy of the breast. It generates both physical and psychological distress, presenting a significant threat to a woman's health-related quality of life. Regarding Physical Distress Macromastia always associated with a number of musculoskeletal complications, including neck pain, back pain, headache, peripheral neuralgias, and shoulder pain. Often, women with mammary hypertrophy experience intertriginous skin maceration and other rashes, as well as infections all the result of heavy, pendulous breasts. In short, a woman's breast size can affect her attitudes, career choices, and personal life in many ways.

Ideal technique should end in a beautiful breast, which has good size with fullness in the upper part, attractive shape with adequate projection, elegant curves, and a nipple areola complex that is pleasing in shape and position. The result should last over years.

The inferior pedicle technique has been described with many variations by surgeons such as Ribeiro and Robbins with the nipple and areola being carried on a dermal pedicle, and it is probably one of the most popular breast reduction techniques currently in use in the United States. Advantages of this are well known. It is a rapid and safe technique that can be used on almost every breast size. It has been shown to be as good as or better than other techniques in the preservation of the neurovascular supply to the nipple. It is easily taught and learned.

The superomedial pedicle technique was first described by Orlando \& Gutherie as a modification of the superior pedicle technique. In this technique the nipple \& areola (NAC) is transposed on a superomedial de-epithelialized pedicle which contains a thin layer of subcutaneous tissue to protect the dermal blood supply.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral breast hypertrophy

Exclusion Criteria:

* Congenital breast anomalies.
* Pregnant, lactating or smoker patient.
* Previous breast reductions.
* Co-morbid diseases e.g. diabetes , liver cirrhosis or thyroid disorders.
* Body dysmorphic disorder
* Patients on long term medications e.g. immunosuppressive drugs, steroids or cytotoxic drugs.
Protocollo N 2014 - Benign Prostatic Hyperplasia

Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.

Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.

Data relating to the clinical conditions (state of the disease, psychological and related to the quality of life) of patients suffering from BPH under medical therapy and/or undergoing surgery will be collected within a specially designed database which will allow us to easily and secure extraction of data used for statistical analyzes in clinical research.

Eligibility Criteria:
Inclusion Criteria:

* subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
* subjects \>= 18 years old
* signature of informed consent

Exclusion Criteria:

* subjects \< 18 years
* presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19

This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

Eligibility Criteria:
Inclusion Criteria:

1. According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary；
2. Aged greater than 18, with no gender limitation;
3. Symptom score greater than or equal 3 points;
4. Voluntarily accept the drug treatment and sign the informed consent.

Exclusion Criteria:

1. Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
2. immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
3. pregnant and lactating women;
4. People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
5. mentally ill persons or persons without self-awareness;
6. Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening;

(8) In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.
Retinal Imaging With Oblique Illumination

Retinal diseases are the major cause of blindness in industrialized countries and while tremendous effort is made to develop novel therapeutic strategies to rescue retinal cells, optimal means to evaluate the effects of such treatments is still missing. Nowadays, diseases diagnosis and treatment monitoring are performed thanks to imaging devices and functional measurements (visual acuity of visual field tests). These eye examinations lead to the detection of large scale damages of the retinal tissue, i.e. the diagnosis is made too late or the treatments cannot be adapted in time. With the developed technology, the goal is to provide a tool to the ophthalmologists that allow for better treatment monitoring and early diagnosis. Indeed, the technology is able to image the retinal tissues with a ten times more detailed visualization as compared to the standard of care (OCT instruments, SLO instruments or eye fundus cameras). Towards this goal, we designed the present protocol in order to test the technology with a clinical prototype (Cellularis version 1) in a clinical environment. The objective is to describe and quantify at the cellular level the retina of patient affected by different retinal diseases as well as the healthy retina of people with different ages. We will assess the repeatability of the instrument and compare the results of the measurements with images obtained with the standard of care (OCT and SLO images).


Eligibility Criteria:
Inclusion Criteria:

Group 1

* Individuals, 18 to 50 yo, with normal eye fundus.
* Emmetropic or ametropic between +3D and -3D

Group 2

* Individuals, 18 to 50 yo, with normal eye fundus.
* Myopic between -6D and -12D.

Group 3

* Individuals over the age of 50 and age-matched to patients with AMD.
* With nwith normal eye fundus.
* Astigmatic, myopic (\<-12D) or presbyopic participants may be included

Group 4

* Patient over 50 yo, with early or intermediate AMD, including extrafoveolar geographic atrophy
* with visual acuity ≥ 0.6 and clinical judgment of good central fixation.

Group 5

* Patient over 18, with other retinopathy than AMD,
* with visual acuity ≥ 0.6 and nd clinical judgment of good fixation

Exclusion Criteria:

Eye with

* RPE detachment
* a clinically unclear situation
* abnormality preventing good visualization of the fundus
* less than 3 months post-surgery of the anterior segment
* less than 6 months post-surgery of the posterior segment
* active uveitis - myopia ≥12D, hyperopia \> +5D, astigmatism \> 4D
* contraindication to dilatation
* a palpebral opening that is less than 6 mm in height

Individual:

* albino - unable to fix a target at least 10 seconds
* who does not tolerate being in the dark for 30 minutes
* unable to follow the procedures of the study
* refusing to be informed of the incidental discovery of a clinically significant pathology Investigators of the study, their family members, collaborators and students
Food Swaps to Improve the Healthfulness and Reduce the Carbon Footprint of Grocery Purchases

The study aims to determine whether viewing health or climate labels (or both) and receiving recommendations for healthier or more climate-friendly swaps (or both) in an online grocery store environment improves the healthfulness and reduces the carbon footprint of consumers' food and beverage purchases compared to shopping as usual without swap recommendations. The online store will record participants' food selections. Participants will also be asked to complete survey measures.

Participants will complete an online between-subjects randomized experiment. The experiment will involve three study visits.

In the first study visit, participants will complete an online grocery store shopping task without intervention. Participants will be given a budget of $50 and asked to shop as they normally would. The store will record participants' food selections. After completing the shopping task, participants will complete an online survey.

Approximately one week later, participants will complete a second study visit with the same instructions. They will be randomized to 1 of 4 conditions (1) health only, 2) climate only, 3) combined health and climate, 4) control. In the health only condition, participants will view labels with nutrition grades and may be directed to swap their selections for healthier items. In the climate only condition, participants will view labels with climate grades and may be directed to swap their selections for more climate-friendly (lower-carbon-footprint) items. In the combined health and climate condition, participants will view labels with health and climate grades and may be directed to swap their selections for healthier or more climate-friendly items. In the control group, participants will not view any labels or swaps. The store will record participants' selections. After completing the shopping task, participants will complete an online survey.

In the third study visit, the participants will maintain their assigned group and will be asked to repeat the same tasks as in the second visit.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Reside in the United States
* Able to complete a survey in English
* Have internet access to complete the 3 online study visits

Exclusion Criteria:

* Under the age of 18
* Reside outside of the United States
* Unable to complete a survey in English
* Do not have internet access to complete the 3 online study visits
Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD

The purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis Chronic Kidney Disease stages G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
* Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin \< 100 ng/mL and/or TSAT \< 20% (KDIGO).

Exclusion Criteria:

* contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin \> 500 ng/mL and/or transferrin saturation \> 50%);
* treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously);
* active smoker status;
* antioxidant food supplements treatment in the last 3 months;
* clinically manifest bleeding;
* another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias);
* severe anemia (Hb \< 7 g/dl);
* baseline FMD \< 7% (the existence of atherosclerosis which limits arterial reactivity);
* cancer (currently or in the past 6 months);
* hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade Child B;
* autoimmune disorders or significant inflammation (as defined by C-reactive protein \> 5 mg/L);
* pregnancy or lactation;
* participation in other clinical trials over the upast 3 months;
* patient unwillingness.
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied


Eligibility Criteria:
Inclusion Criteria:

* Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
* Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45 kg/m²
* Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

* aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3\* upper limit of normal (ULN)
* Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
* Creatinine kinase \>3\* ULN
* Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Walking With FES or AFO in People With MS With Foot Drop

This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.

Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.


Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with Multiple Sclerosis
* Prescribed either AFO or FES to treat drop foot by their physiotherapist
* aged 18-75

Exclusion Criteria:

* Unable to walk 10 meters
* Bilateral device use
* Breastfeeding or pregnant
Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects, age 18-65 years, inclusive.
2. BMI 18-33 kg/m2
3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

   * LDL-C ≥3.24 mmol/L (≥125 mg/dL)
   * Triglycerides (fasted) \<2.7mmol/L (\<239 mg/dL)
   * ALT within normal limits

Exclusion Criteria:

1. Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
2. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
3. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
4. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
5. Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
6. Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.