cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.

Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C\&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C\&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C\&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.

Eligibility Criteria:
Inclusion Criteria:

* Well-defined primary, not previously treated nodulo-cystic BCC
* Size of the lesions: ≤ 1cm diameter
* Facial lesions
* Patient compliance competent
* Patient physically able to apply the treatment (cream)

Exclusion Criteria:

* Recurrent lesions
* Superficial, morphoeic or pigmented BCC
* Lesions close to vital structures; i.e. where C\&C is not considered a standard treatment (eyelids, inner canthus, free borders)
* Lesions within 1 cm of the eyelids, nose, lips and hairline
* Immunosuppressed patients
* Women in childbearing age, pregnancy and breast-feeding
* Ages \<50 or \>90
* Patients compliance incompetent
* Patients physically incapable to apply the treatment (cream)
* Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)
Infrared Imaging in Complex Regional Pain Syndrome

This research proposal aims to investigate the potential use of Infrared (FLIR) imaging to monitor the successful achievement of the sympathetic blockade in patients with complex regional pain syndrome (CRPS).

Sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain. Despite the frequent use of these blocks, there remains a need for an objective method to determine the achievement of a sympathetic block in the clinical setting.

Current clinical practice assess the success of a sympathetic block by observation of clinical signs of sympathetic blockade. These signs include monitoring skin temperature, pulse amplitude, blood oxygen, or any combination of these methods. However, clinical signs of sympathetic blockade often demonstrate an unpredictable or delayed response and can make monitoring difficult.

Therefore, it is necessary to develop an objective monitoring method that is reliable, rapid response, and not affected by the other confounders. One potential method is the use of thermal camera imaging (FLIR).

Such a monitor could increase procedural accuracy and efficiency, thus improving patient care. To plan the prospective treatment options, objective confirmation of successful sympathetic block is essential to differentiate sympathetically mediated pain (SMP) versus sympathetically independent pain (SIP).

In this context, utilization of a monitor with a rapid response and easy clinical applicability, would serve as an objective endpoint for evaluating sympathetic blockade both clinically and for future research.

Therefore, this research proposal aims to investigate the infrared (FLIR) thermal camera as an objective method for determining the achievement of sympathetic block in the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between 18 and 85 years old
* Providing CRPS diagnostic criteria by using Budapest Clinical criteria \[16\]
* The patient has had pain and other symptoms for more than 3 months
* Not responding to conventional medical treatments and multidisciplinary approach
* High NRS detection in pain assessment despite appropriate treatment (NRS = and \> 6/10).
* Pain is a limitation in the patient's functional capacity despite appropriate treatment.

Exclusion Criteria:

* Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
* Systemic or local infection
* Coagulation disorders
* History of allergy to contrast material
* Malignancy
* Pregnancy
* Uncontrollable medical and psychiatric condition
* The patients diagnosed with dysautonomia, sympathetic dysfunction (such as Raynaud disease or Buerger disease), sweating disorders (such as acquired idiopathic generalized anhidrosis), and patients on vasoactive drugs, the mechanism of action is directly on the vascular tone.
Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Either sex but must be aged \>=18 years.
* Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster \>=6 months after the herpes zoster skin rash has healed.
* Pain score over the last week of \>=3 and \<=8 on the PI-NRS
* If female, the subject must be postmenopausal , surgically sterilized for \>=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
* Willing and able to comply with all study procedures.

Exclusion Criteria:

* Severe pain caused by diseases other than PHN.
* Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
* History of seizure, excluding pediatric febrile seizures, or currently has seizures.
* Stroke or transient ischemic attack (TIA) \<=6 months before the screening visit.
* History of or a current diagnosis of schizophrenia or bipolar disorder.
* Major depressive disorder or generalized anxiety disorder \<=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study.
* Clinically significant alcohol or substance dependency \<=1 year before the screening visit
* Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit.
* Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety.
* Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed \>1 year before screening and has not recurred).
* Condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Illness within 30 days before screening.
* History of hypersensitivity to calcium channel blockers.
* Multiple drug allergies
* Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose capsaicin patch (Qutenza) \<=30 days before the screening visit.
* Moderate or strong cytochrome P450 inducer within 30 days before the screening visit.
* Digoxin or prohibited medications that cannot be discontinued before randomization.
* Other exclusions apply.
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis

This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and/or GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR/GCA to GCs.

Polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) are closely related inflammatory rheumatic diseases. The first-line treatment of both PMR and GCA are glucocorticoids (GC). In PMR, initial oral prednisone equivalent doses in between 10 and 25 mg/day are given. In contrast, GCA is usually treated with significantly higher steroid doses (starting dose 1 mg/kg body-weight) to prevent vascular complications.

The dose and duration of steroid treatment needed to control disease in patients with PMR and GCA vary and about half of the patients experience relapses, early upon GC dose tapering or after discontinuation of treatment. The reasons for the inter-individual differences in steroid-response are not known. Data from this controlled prospective study will help to identify subjects with GC resistance which would allow to use intensified treatment strategies (higher dose or alternative immune modulatory therapy) to overcome resistance. On the other hand, strong responsiveness to GC would provide a rational for rapid steroid tapering or treatment with lower doses, both resulting in reduced risk for GC related adverse events such as osteoporosis, infections, diabetes and mood disorders. Detailed understanding of the relation of individual GC signaling and GC metabolism with patients' response to steroid treatment will help to define steroid responder profiles. This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and/or GCA.

At inclusion and at all follow-up visits, the clinical evaluation will be documented in the SCQM database. All participants with PMR will be treated according to our local treatment protocol: starting dose is 15 mg prednisone/d, tapered by 2.5 mg every second week once symptoms are controlled. After tapering to 10 mg/d, prednisone dose is further reduced by 2.5 mg every month.

All patients with GCA are treated according to published guidelines with prednisone starting at 1mg/kg body-weight followed by reduction to 0 mg at week 26 (GIACTA protocol).

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria
* Consent to participate in the SCQM database
* Treatment according to our standardized regimes

Exclusion Criteria:

* Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion
* History of GCA and PMR in the past
* Inability to give informed consent
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.

Eligibility Criteria:
Prospective Cohort Inclusion Criteria:

* Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.

Retrospective Cohort Inclusion Criteria:

- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.

Prospective Cohort Exclusion Criteria:

1. Patients unable to understand either an English or Spanish consent will be excluded.
2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure

The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure

There are now \>500 million adult humans in the world who are overweight \[body mass index (BMI) of 25.0-29.9 kg/m2\] and 250 million who are obese (BMI 30 kg/m2). This growing epidemic threatens both industrialized and developing countries and has been accompanied by worldwide increases in obesity-related disorders, including type II diabetes, hypertension, cardiovascular pathology, and nonalcoholic fatty liver disease. In the United States, 64% of adults are overweight or obese, prompting the Surgeon General to designate this condition as the most important public health challenge of our time.

The worldwide obesity epidemic is stimulating efforts to identify host and environmental factors that affect energy balance. The Human gut contains an immense number of microorganisms, collectively known as the microbiota. This community consists of at least 1013 citizens, is dominated by anaerobic bacteria, and includes 500-1,000 species whose collective genomes are estimated to contain 100 times more genes than our own human genome. The microbiota can be viewed as a metabolic "organ" exquisitely tuned to our physiology that performs functions that we have not had to evolve on our own. These functions include the ability to process otherwise indigestible components of our diet, such as plant polysaccharides, and therefore may have an impact on our energy balance.

Comparisons of the distal gut microbiota of genetically obese mice and their lean littermates, as well as those of obese and lean human volunteers have revealed that obesity is associated with changes in the relative abundance of two dominant bacterial divisions, the Bacteroidetes and the Firmicutes. Turnbaugh et al demonstrated through metagenomic and biochemical analyses that these changes affect the metabolic potential of the mouse gut microbiota. Furthermore, this trait is transmissible: colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota'. These results identify the gut microbiota as an additional contributing factor to the pathophysiology of obesity. It has been suggested, therefore, that the obese microbiome has an increased capacity to harvest energy from the diet.

Eligibility Criteria:
Inclusion criteria

* 40 patients that refers to helicobacter pylori treatment
* Aged 20-60 years old
* 22 Kg/m2 ≤ BMI ≤ 30 Kg/m2
* Functional GI trace with permanent stool number
* Keeping on a permanent diet
* Written informed consent
* Stated availability throughout the study period
* Mental ability to understand and follow the protocol

Exclusion criteria

* Use of laxatives
* Confirmed GI tract infections or inflammatory bowel disease
* Any major chronic illness
* Pregnancy
* Participation in other clinical trials
* Use of oral or intravenous antibiotics during 8 weeks prior to recruitment
A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110

The purpose of this first-in human (FIH) study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple doses of KRRO-110 in both healthy adult participants and in clinically stable patients with Alpha-1 antitrypsin deficiency (AATD).


Eligibility Criteria:
Inclusion Criteria:

Part A SAD cohort Inclusion Criteria (Healthy Volunteers)

* Adult male or female participants, 18 to 65 years of age
* Documented PiMM genotype
* Participants who are willing to and able to provide signed written informed consent

PiZZ Genotype (Part A SAD and Part B MAD cohorts) Inclusion Criteria (PiZZ Genotype)

* Adult male or female participants 18 to 70 years of age (inclusive)
* Documented PiZZ genotype
* Baseline blood total AAT level \< 11 µM/L

Exclusion Criteria:

Exclusion Criteria (Healthy Volunteers)

* Female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception
* Body mass index (BMI) \> 32 or \< 18.5 kg/m2
* History or current clinical evidence of hepatic disease
* Evidence of active infection
* History of medical condition(s), eg, advance cardiac disease, current or recent malignancy, organ transplantation, or other illness
* Serology result indicative of any exposure (past or active) to hepatitis C, hepatitis B, or human immunodeficiency virus (HIV)
* Respiratory or other acute illness within 8 weeks
* Tobacco use of any kind within 6 months

Exclusion Criteria (PiZZ Genotype)

* Female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception
* BMI \> 32 or \< 18.5 kg/m2 or weight \> 90 kg
* History of FEV1 \< 50%
* History or current clinical evidence of advanced hepatic disease and/or pulmonary disease
* Use of an experimental therapy except KRRO-110 within 6 months or 5 half-lives for the experimental therapy, whichever is greater
* Tobacco use of any kind within 6 months
* Use of conventionally dosed AAT augmentation therapy within 5 half-lives
* Serology result consistent with exposure to HIV, or serology consistent with active hepatitis B or hepatitis C infection
Materialise X-ray Knee Guides for Total Knee Arthroplasty

The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Physically and mentally able and willing to comply with the protocol
* Be treated for a primary total knee arthroplasty
* Are fluent in Dutch or French
* Sign the Informed Consent Form
* Comply with the indications listed in the Instructions for Use
* Be able to undergo a CT scan

Exclusion Criteria:

* Fulfilling one of the contraindications mentioned in the Instructions for Use
* Pregnant
* A prisoner
* Reported to have mental illness or belonged to a vulnerable population
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)

Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia.

This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be informed about the study, and will have read; understood and signed the informed consent
* Subjects of either gender that are at least the age of 18 years
* Subjects will be undergoing ileostomy reversal with retromuscular placement technique of the Phasix biosynthetic mesh reinforcement

Exclusion Criteria:

* Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
* Subjects with parastomal hernia or midline incisional hernia
* Subjects who required midline laparotomy during ileostomy reversal
Emotional Association Bias Modification Training in Individuals With IGD

This project aims to investigate (1) the efficacy of emotional association bias modification (EABM) training on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy

As with the efficacy, the experiment aims to test whether EABM training will reduce positive emotional association bias towards gaming, compulsive choice of gaming pictures, cue-induced craving for gaming, the severity of gaming behaviors in individuals with IGD.

As with the underlying neural mechanisms, the experiment aims to test whether EABM training will alter the activation of reward circuits in response to gaming pictures, the activation of executive control network (mainly refering to the prefrontal cortex) regarding regulation ability for craving and response inhibition ability.

Eligibility Criteria:
Inclusion Criteria:

1. the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder :

   the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.

   engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.
2. the scores of the Young-Internet addiction Test ≥ 50

Exclusion Criteria:

1. current or history of use of illegal substances and other addictions;
2. current or history of psychiatric or neurological illness;
3. current use of psychotropic medications.
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women

Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.

Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder (HSDD) in women has been demonstrated in studies including naturally and surgically menopausal women, either alone or in combination with estrogen, with or without progestin therapy.

Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.

There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido.

Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment.

Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants.

Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known.

The primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS).

In line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status.

In this present study these factors will be analized in 12 weeks interval

Eligibility Criteria:
Inclusion Criteria:

* a body mass index between 18 and 35 kg/m2
* diminished libido complaints
* no evidence of severe clinical depression
* participants in good health based on history and physical examination.

Exclusion Criteria:

* a past history of neurological disorder
* recent psychiatric or systemic illness
* use of psychoactive medications
* alcohol excess consumption or any other drug abuse.
* women who had under gone treatment for cardiovascular disease, genital bleeding, acne, depression, dyspareunia or those who had received oral androgen therapy in the previous 3 months were excluded
* in addition women taking medications known to interfere with sex steroid metabolism were also excluded.