cyrilzakka/clinical-trials huggingface dataset:
Disulfiram for Cocaine Abuse in Buprenorphine Treatment

The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

The Specific Aims and hypotheses for the proposed study are as follows:

1. To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo.
2. To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH.
3. To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults ages 18 - 45.
* Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
* Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.

Exclusion Criteria:

* Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
* Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
* Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT \> 3X normal) will also be excluded.
* Presence of any of the following cardiovascular risk factors:

  * age \> 45 years
  * history of cocaine-related chest pain
  * systolic blood pressure \> 140 or diastolic blood pressure \> 90
  * evidence of ischemia or past myocardial infarction on EKG
  * significant family history of risk (first degree relative with myocardial infarction prior to age 60)
  * elevated cholesterol (\> 300 mg/dl), elevated LDL (\> 170 mg/dl) or low HDL (\< 20 mg/dl)
* Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
* Current suicide or homicide risk or current psychotic disorder.
* Inability to read or understand the symptom checklists.
Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes

PhytoSpherix (Phx) is an all-natural, edible polysaccharide extracted from sweet corn. This carbohydrate is the major muscle fuel for intense exercise and its stores are quite small such that one can run out of it during a single exercise bout. Therefore, Phx should provide significant exercise fuel if consumed during exercise. As a result its intake could enhance intense exercise performance by providing additional fuel. This experiment Will investigate the effects of 4 different dosages of Phx consumed throughout a prolonged exercise bout on carbohydrate and fat utilization as well as its oxidation rate and perception of effort during prolonged intense exercise in trained cyclists. Muscle and liver carbohydrate stores will be examined using a non-invasive ultrasound technique.

Carbohydrate (CHO) is one of the main substrate oxidized during moderate-to-high intensity, endurance-type exercise. It's been shown that CHO feeding during exercise enhances endurance performance and capacity, attributed mainly to the facilitation of greater rates of exogenous CHO oxidation, prevention of hypoglycaemia and sparing of muscle glycogen. Previous studies based on supplementation of glucose during 180 min. of cycling exercise have reported a maximal rate of exogenous CHO oxidation to be about 1 g/min. Other studies have shown that CHO oxidation rates can reach peak values of about 1.3 g/min when a combination of fructose and glucose is ingested at a rate of 1.8 g/min. The limitation in uptake and oxidation of a single CHO source is attributed to its intestinal transporter saturation such that when multiple CHO source is used the uptake and oxidation rate is increased to a greater extent. Currently there is no information regarding Phx uptake or oxidation rate as a CHO source during exercise. Also, it is important to investigate whether Phx as a CHO sport drink can increase performance by sparing muscle and liver glycogen during exercise. Therefore, the objective of this experiment is to measure dose response of Phx oxidation rate during prolonged cycling exercise and its effect on muscle and liver glycogen levels.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male endurance trained athletes with \>2 y cycling experience; about 2 h/day

Exclusion Criteria:

* Unhealthy athletes, smokers
Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial

To determine whether giving folic acid to people with depression will help their antidepressants work better. If folate does help antidepressants to work better, then it will provide a safe, simple and cheap way of improving the treatment of depression.

Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.

The primary objective of this multi-centred placebo-controlled randomised trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.

Comparisons: Eligible patients with moderate to severe depression will be randomised to receive 5mg of folic acid or placebo as an adjunct to their antidepressant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Only patients aged 18 or over
* ICD-10 diagnosis of moderate to severe depression
* Able to give informed consent (not delirious, actively psychotic or with severe communication or learning disability)
* Able to complete the research assessments

Exclusion Criteria:

* are folate deficient
* are B12 deficient
* have knowingly taken supplements containing folic acid within 2 months
* suffer from psychosis
* are already participating in another research project
* are pregnant or planning to become pregnant
* are taking anticonvulsants
* have a serious, advanced or terminal illness with a life expectancy of less than 1 year
* have recently started treatment for a medical condition which has not yet been stabilised
* are taking lithium
* have had a diagnosis or treatment for any malignant disease or any related condition such as intestinal polyposis
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery

The study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

* refused to participate
HILT for Meralgia Paresthetica

This randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Participants with MP will be randomly allocated to either the HILT or sham HILT (control) group. The study will evaluate the effects of HILT on pain intensity, functional outcomes, and quality of life. Findings from this trial will provide insights into the potential benefits of HILT as a non-invasive and safe treatment option for patients with MP.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Meralgia Paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies.
* Presence of pain, numbness, or tingling in the anterolateral thigh for at least three months.
* Aged between 35 and 55 years.
* Willing and able to provide informed consent.
* Able to comply with the study protocol and attend all treatment sessions and follow-up assessments.

Exclusion Criteria:

* Previous surgical treatment for Meralgia Paresthetica.
* Concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis.
* Presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy
* Significant trauma or surgery to the affected thigh or lumbar spine within the past six months.
* Pregnancy or planning to become pregnant during the study period.
* Known contraindications to High-Intensity Laser Therapy, such as active skin infection, malignancy, or photosensitivity disorders.
* Current use of anticoagulant medications or immunosuppressive therapy.
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.


Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for study participation will satisfy the following criteria:

  * Birth weight between 1000g -1800g
  * Less than or equal to 34 weeks and 0 days gestational age at birth
  * Appropriate for gestational age (AGA)
  * Singleton or twin births
  * Infant is 21 days of age or less

Exclusion Criteria:

* Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:

  * Expected to be transferred to another facility within 14 days
  * Serious congenital abnormalities that may affect growth and development
  * Intubated for ventilation at the time of study product initiation
  * Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
  * Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
  * Infant has a history of major surgery
  * Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
  * Confirmed necrotizing enterocolitis or confirmed sepsis
  * Current use or planned use of probiotics
  * Participation in another study that has not been approved
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18 and ≤ 30 kg/m2
* Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours
* Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

Exclusion Criteria:

* Refusal to be included
* Allergy or unsuitability to any composition of study drugs or remifentanil
* Living expectancy less than 48 hours
* Myasthenia gravis
* Status asthmaticus
* Abdominal compartment syndrome
* Serious hepatic dysfunction (CTP 10-15);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
* Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
* Possible requirement for surgery or bedside tracheostomy in 24 hours
* Possible requirement for renal replacement therapy in 24 hours
* Acute severe neurological disorder and any other condition interfering with sedation assessment
* Abuse of controlled substances or alcohol
* Pregnancy or lactation
SP16 as a Therapeutic for COVID-19 Induced ARDS

This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.

SARS-CoV-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. SP16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. SP16's mechanism of action is through targeting LRP1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. The main objective of this study is to determine the safety and tolerability, and effects on inflammation of SP16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). SP16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. The study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both SpO2 \> 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the Intensive Care Unit (ICU).

Eligibility Criteria:
Inclusion Criteria:

To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:

* Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive
* PCR test result and can provide informed consent
* Diagnosed with pneumonia due to SARS-CoV-2
* Respiratory rate ≥ 25/minute and SpO2 ≤ 93%
* Review of Chest radiograph, chest computed tomography (CT) scan, or chest ultrasound consistent with bilateral infiltrates.
* Horowitz index (partial pressure of oxygen/fraction of inspired oxygen \[PaO2/FiO2\]) ≤ 300. If a subject does not have an arterial line in place, a SpO2/FiO2 ≤ 315 may be used.

Exclusion Criteria:

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:

* Age \< 18
* Pregnant or lactating women
* History of heart failure
* Clinically significant cardiac dysrhythmia, as determined by investigator
* History renal impairment
* Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase
Consequences of Nocturnal and Daytime Hypoxemia in COPD

We will determine whether oxygen therapy lowers the level of substances in the blood which cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves overall well being and quality of life as well as sleep quality.

Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.
* Clinical stability defined by absence of treatment change or need for acute care within the last two months.
* Weight stable, within 5%, in the previous three months as measured during office visits.
* Willingness to participate in a clinical study.

Exclusion Criteria:

* Acute illness within the preceding 2 months.
* Patients who received systemic glucocorticoid therapy within the past month.
* Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is \> 0.4 or if the ODI 4% is \>15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.
* Hypercapnia defined as PaCO2 \> 50 mmHg on resting arterial blood gas
* Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.
* No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.
* Primary care or pulmonary physician refusal.
* Patient refusal for any reason.
* Lack of capacity to participate in the informed consent process.
Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. The investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.

Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:- Moderate to severe pain (greater than 4/10) of duration more than 6 months despite previous therapy.

* The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
* The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar
* Age 18-100
* Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Exclusion Criteria:

1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
2. Any ongoing legal action related to their pain
3. Allergy to local anesthetics
4. A current or history of any severe psychiatric disorder
5. History of any adverse reaction to botulinum toxin
6. History of botulism
7. Untreated infection
8. Coagulopathy
9. Females - positive pregnancy test
10. Surgery within the past 6 months at the site of the painful scar
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.

A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established diagnosis of AS steinbrocker functional class I-II
* Basic medication stable for at least three months
* Agreed to participate and signed term of informed consent

Exclusion Criteria:

* Uncontrolled hypertension
* Coronary artery disease
* History of revascularization
* History of syncope or arrhythmias induced by exercise
* Decompensated diabetes mellitus
* Severe psychiatric illness
* Fibromyalgia
* Another medical condition more disabling than AS
* History of exercise regular (at least 30 minutes 2 times per week)
AI Driven Biofeedback Wearable

The purpose of this study is to conduct a comprehensive clinical and biomechanical screening of high school, collegiate-level, recreational, and Olympic/professional-level athletes with the goal of identifying individual functional and performance deficits that lead to future injury.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 12 - 65 years old.
* Athlete at High School, Collegiate, Recreational, Olympic / Professional level.

Exclusion Criteria:

* Indidividual under 12 or over 65 years old.
* Lower extremity injury in the past 6 months.
* History of neurological disease, vestibular or visual disturbance.
* Any other pathology that would impair motor performance.
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses

Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the IOLMaster evaluation;
* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
* Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

* BCVA not available preoperatively or better than 0.3 logMAR pre-op
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Concurrent participation in another drug or device investigation -