cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.
Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.

The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes


Eligibility Criteria:
Inclusion Criteria:

- Age from 12 years to 50 years. Patients with hypertrophic scars and keloids

Exclusion Criteria:

Age below 12 years and above 50 years. Patients received other treatment modalities for hypertrophic scars and keloids.

Systemic and other skin diseases. Patients were already receiving supplemental vitamin D.
Minimizing Nausea and Vomiting During Spinals for CS

In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.

The hypothesis of this study is as follows: In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.

The study group will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given .4mg \[1cc of glycopyrrolate\], with the starting of the infusion

The control group, will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given a placebo \[1cc of N saline\], with the starting of the infusion

Following the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant
2. American Society of Anesthesiologists risk classification I and II
3. Age \> 18 years
4. Non-laboring
5. Patients with elective cesarean sections

Exclusion Criteria:

1. Non- English speakers
2. Height \< 4' 11"
3. BMI \>40 Kg/ mm
4. Antiemetic drug use in the 24 hours prior to cesarean delivery,
5. Hypertensive diseases of pregnancy
6. Chronic hypertension receiving antihypertensive treatment
7. Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia

Chronic pain represents an important health problem responsible for decreases in quality of life, and is associated with great negative impact in society and economy. In many cases, its treatment does not reach therapeutic success causing health professionals and patients dissatisfaction. Chronic pain is also associated with somatization, hopelessness and catastrophizing thinking. These information processing includes sensorial, emotional and cognitive-appraisal thinking, which manifests the working of neural networks at cortical and sub-cortical levels. Attention and memory are a central aspect in the processing of pain modulation. Like in addictions (e.g. smoking, alcohol), chronic pain may debut with displacement in the focus of attention and alterations in the sensorial processing in the incentive-motivation tests. Considering that other studies have indicated that experimental and clinical pain is capable of modulating cognitive activities such as attention,memory and expectation, in this study the investigators will test whether cognitive training, tDCS, or the combination of both interventions decrease cognitive deficits associated with Fibromyalgia

Will be included women aged between 18 and 65 years, chronic pain fibromyalgia according to the criteria of the American College of Rheumatology, pain unresponsive to analgesics such as paracetamol, acetylsalicylic acid, ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and Codeine and give informed consent to participate after initial evaluation. Primary outcome is to Evaluate whether the tDCS associated with cognitive retraining technique is able to modulate attentional bias in fibromyalgia patients. Secondary outcomes are: compare the effect of active tDCS and sham in: Assessed with the Visual Analog Scale for 8 days, Functional capacity, Conditional pain modulation (CPM), Maximal Heat Pain tolerance,Catastrophic thinking,Serum levels of Brain Derived Neurotrophic Factor (BDNF), Beck Depression Inventory, forward and backward digit span( WAIS),Pittsburgh sleep quality and State-Trait Anxiety Inventory (STAI) test.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* literate
* right-handed
* 18 to 65 years of age
* who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

Exclusion Criteria:

* Pregnant women
* Contraindications to tDCS
* Metal implant in the brain
* History of alcohol or drug abuse in the last six months
* History of neurological disorders
* Unexplained fainting
* Self-reports of head injury or momentary loss of awareness
* Neurosurgery.
* Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to Visit 1.
* Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
* Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).
* History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
* Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
* Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus).
* Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.
MEthods for LOcalization of Different Types of Breast Lesions

In the last decades, the proportion of breast cancer (BC) patients receiving breast-conserving surgery has increased steadily, reaching 70-80% in developed countries. Since positive resection margins are strongly associated with local recurrence risk, the goal of breast surgery is the complete tumor removal and most national and international guidelines recommend re-operation, either in form of re-excision or mastectomy, until clear margins have been reached. Re-operation rates vary widely, with population-based studies reporting a range of 15-35%, and the necessity for a second surgery can lead to increased patient anxiety, a delay in start of adjuvant treatment, worse cosmetic outcome and increased complication rates and costs. Therefore, re-operation rate has been included as a quality indicator in several countries.

Several imaging-guided techniques have been developed to guide removal of non-palpable breast lesions, the oldest one being preoperative wire placement under ultrasound or mammographic guidance, usually followed by radiography or ultrasound of removed tissue. Newer techniques, such as intraoperative ultrasound (IOUS), radioguided occult lesion localization (ROLL), radioactive seed localization (RSL), radar reflector-localization (RRL), magnetic seed localization (MSL), and radiofrequency identification (RFID) tags have been introduced as an alternative to wire-guided localization (WGL).

To date, comparative data on the rates of successful lesion removal, negative margins, re-operation rate and patient's comfort depending on the localization technique used are limited. Further, since some of these studies were funded by the manufacturer of the marker examined, a potential bias cannot be excluded. In the vast majority of the available studies, the patient's perspective with regard to discomfort and pain level has not been evaluated.

The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of malignant breast lesions with regard to oncological safety and patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed)
* Planned surgical removal of the lesion using one or more of the following imaging-guided localization techniques:

  * Wire-guided localization
  * Intraoperative ultrasound
  * Magnetic localization
  * Radioactive seed localization
  * Radioguided Occult Lesion Localization (ROLL)
  * Radar localization
  * Radiofrequency identification (RFID) tag localization
  * Ink/carbon localization
* Female / male patients ≥ 18 years old

Exclusion Criteria:

* Patients not suitable for surgical treatment
* Patients requiring mastectomy as first surgery
* Surgical removal without imaging-guided localization
Effect of Orange Juice on Glycemic Response

Orange juice naturally contains high concentrations of hesperidin, which affects glucose absorption in in vitro experiments. This study is to test if hesperidin and other components of orange juice (not other sugars or organic acids) affect the post-prandial blood glucose concentration derived from sugars already present in the orange juice.

Healthy volunteers will consume orange juice with added water or food-grade hesperidin.

Eligibility Criteria:
Inclusion Criteria:

* fasting blood glucose below 5.9 mM

Exclusion Criteria:

* fasting glucose above 6 mM pregnant
Performance Evaluation of Tattoo Removal

Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal

The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male subjects between 18 to 65 years of age
* Fitzpatrick Skin Type I - VI
* Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
* Have a tattoo contains containing single or multi-color ink.
* Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
* Must be able to read, understand and sign the Informed Consent Form
* Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
* Agree not to undergo any other procedure(s) for the tattoo removal during the study.

Exclusion Criteria:

* Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
* Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
* History of allergic reaction to pigments following tattooing.
* History of hypersensitivity to light exposure
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
* History of malignant tumors in the target area.
* Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment or during the treatment course
* Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
* History of keloid scarring, abnormal wound healing and / or prone bruising
* Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
* Suffering from coagulation disorders or taking prescription anticoagulation medications.
* History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
* History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
* History of vitiligo, eczema, or psoriasis.
* History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
* History of seizure disorders due to light.
* Suffering from Histoplasmosis, hyperparathyroidism, Lymphoma, kidney disease, sarcoidosis, tuberculosis, high levels of calcium in the blood
* Suffering from Vitamin D deficiency
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity

Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Probiotics are living bacteria which are found in the normal gut microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity.

This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class III, with follow up of 90 days.

Obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein.

Potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. Its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity.

This study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. The methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days.

Patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). Probiotics are: Lactobacillus acidophilus; Lactobacillus rhamnosus; Lactobacillus paracasei; Bifïdobacterium lactis.

At the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity C-reactive protein, albumin, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).

Eligibility Criteria:
Inclusion Criteria:

* Obesity class III (body mass index ≥40kg/m2)

Exclusion Criteria:

* Current use of prebiotics and probiotics or use in the last three months
* Intolerance to prebiotics and probiotics
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
* Histologically confirmed stage III (unresectable) or stage IV melanoma
* Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Uveal melanoma
* Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply
Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries

Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. However, few studies have investigated the role of AAT in the post-operative course in adults. This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC).

This study will be a randomized control design. Within 48 hours of admission, the study team will approach eligible patients admitted to the inpatient trauma service to discuss the study and obtain informed consent from patients expected to be admitted for 3-7 days. Consenting patients will be randomized to either a) participate in 2-3 ten-minute dog visits or b) receive 2-3 ten-minute visits with a handler alone. Within 24 hours after the last anticipated study visit, a member of the study team will administer a survey to assess participants' pain, depression, anxiety, mood, and emotional quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
* English or Spanish speaking
* Able to provide informed consent

Exclusion Criteria:

* Fear of dogs, allergy to dogs
* Immunocompromised
* Contact precautions
* Delirious, intubated, or otherwise unable to consent
Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects

The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Healthy male subjects
* Age 18-45 years, inclusive

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the first dose of study drug
* History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
* Need for concomitant medications during the study