cyrilzakka/clinical-trials huggingface dataset:
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients from 9 months of age up to 98 years of age.
* Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.
* The patient, and if applicable the parent or guardian, is able to give informed consent
* Females of child bearing potential have a negative urine pregnancy test.
* Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.

Exclusion Criteria:

* Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.
* Subject who has been enrolled in a clinical trial within the last 30 days.
* Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.
* Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator
* Subjects who have taken oral antibiotics within the last 7 days.
* Subjects with known sensitivity to the study medication.
* The subject is pregnant or breastfeeding
Neurofeedback as a Treatment for Trauma-affected Refugees

Neurofeedback (NF) is a form of treatment that can assist individuals in learning to control their brain wave activity. NF-studies have shown promising results in reducing PSTD-symptoms among military veterans, but there are no published peer-reviewed studies with refugees. However, preliminary studies from Malmö and Sydney indicate that refugees could benefit from NF. Therefore, at the Competence Centre for Transcultural Psychiatry (CTP) a longitudinal feasibility study, testing NF for trauma-affected was started. The study contains both a quantitative and a qualitative substudy. In in the quantitative substudy, where a total of 32 participants have been included, the aim was to evaluate the feasibility of NF with trauma affected refugees using a quantitative perspective. The NF intervention offered was 12 training sessions of 12-20 minutes NF, and the outcome measures were self-administered questionnaires and semi-structured interviews collected before and after the intervention. In a subsample of eight participants of those included in the quantitative substudy, qualitative in-depth interviews were carried out. The participants were offered two interviews; one before the first NF training and one during the treatment course. The aim of the qualitative substudy was to evaluate the feasibility of NF with trauma-affected refugees by examining the participants' thoughts and expectations prior to participating in NF treatment as well as their experience with the treatment after a few sessions.


Eligibility Criteria:
Inclusion Criteria:

* Refugee or a person who had been family reunified with a refugee
* Diagnosed with PTSD (ICD-10 diagnosis F43.1) and experienced a psychological trauma in another country than Denmark.
* Informed consent.

Exclusion Criteria:

* Current abuse of drug or alcohol (F1x.24-F1x.26)
* Diagnosed with a severe psychotic disorder (F2x) or a manic disorder (F30.1-F31.9).
* No informed consent.
Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.

Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type)
* Tumor staged as III-IVA (according to the 8th AJCC edition).
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
* Age between 18 and 65 years old.
* Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* Evidence of distant metastasis
* Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Other previous or concomitant cancer.
* Pregnancy or lactation.
* Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery

The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients
* Preoperative platelet count higher than 150,00/ mm3
* Patient who required bilateral mandibular third molar extractions

Exclusion Criteria:

* Smokers patients
* Alcoholics patients
* Patients whom the inferior second molar was missing
* Patients who had acute pericoronitis on the inferior third molar
* Severe periodontal disease
Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

Neck pain is a common, multifactorial condition. In the case of degenerative cervical spinal disease, it can result from changes in the intervertebral discs, muscles, intervertebral joints, or sagittal imbalance. Anterior cervical discectomy and fusion (ACDF) is a currently widely accepted procedure for treating cervical degenerative spine disease, with a high patient satisfaction rate. In the current state of knowledge, it is not used for treating axial neck pain, but rather in cases of discopathy causing spinal myelopathy or cervical radiculopathy, in which neck pain often coexists or predominates. The current literature provides ample evidence of the significant effect of ACDF in improving axial neck pain in the conditions mentioned previously. However, little information exists on which patients achieve improvement. The aim of this prospective study is to analyze the outcomes of ACDF in patients with neck pain and to identify predictors of reduction in axial neck pain after ACDF.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology

Exclusion Criteria:

* Previous cervical spine surgery
* Previous cervical spine trauma
* Other diseases causing neck pain include rheumatoid arthritis, lupus, polymyalgia rheumatica, myositis, seronegative inflammatory diseases, and fibromyalgia
* Drug abuse
* Myelopathy
* Spinal infection
* VAS neck pain score less than 3 (Inability to achieve an MCID which is calculated as 2.5 for the VAS scale)
Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 20 years old during the recruitment phase
2. Clinical diagnosis of CTS：

   1. Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
   2. Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase
3. Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
4. The subject is willing and able to comply with the procedure and requirements of this trial
5. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements

Exclusion Criteria:

1. Wrist fractures or cysts at the CTS affected side
2. Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
3. Receiving upper limb (including neck) surgery
4. Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
5. With a past medical history of diabetic polyneuropathy
6. With a past medical history of rheumatoid arthritis
7. With a past medical history of epilepsy
8. Body Mass Index (BMI) \> 40 kg/m2
9. Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
10. Active infection at the stimulator contact site during the recruitment phase
11. Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
12. Patients with implanted medical devices that are electronic products, such as implantable cardioverter defibrillators, pacemakers, spinal cord stimulation systems, or spinal cord drug infusion pumps
Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?

The purpose of this study is to determine the effect of relaxation exercises on pain level and pain medication use after arthroscopic rotator cuff shoulder surgery


Eligibility Criteria:
Inclusion Criteria:

1. Males and nonpregnant females aged 18 years or older
2. full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery

Exclusion Criteria:

1. Patients with an irreparable tear, revision shoulder surgery, multiple shoulder surgeries, concomitant severe glenohumeral arthritis, concomitant adhesive capsulitis
2. worker's compensation claim
3. diagnosed psychological disorder
4. history of alcohol or drug abuse
5. patients on preoperative narcotic therapy
6. patients who already practice relaxation techniques (i.e. mindful meditation, guided imagery, breathing exercises, yoga, etc.).
Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy levels and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday's responsibilities, at its worst, depression can lead to suicide. Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80% of those affected and can be delivered in primary care.

In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Mild antidepressant effects of rTMS applied to the left sided dorsolateral prefrontal cortex (DLPFC) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. First hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be more effective to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

Eligibility Criteria:
Inclusion Criteria:

* Episode of depression (unipolar or bipolar)( ICD-10)
* Female or male between 18 and 70 years old
* Skills to participate in all study procedures
* 18 or more points in the Hamilton rating scale or depression
* Stable antidepressant drugs
* Written informed consent

Exclusion Criteria:

* Clinically relevant unstable internal or neurological comorbidity
* Evidence of significant brain malformations or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorders affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Epilepsy or a pathological EEG
* Heart pacemaker
* High dose tranquillizers
Postoperative Recovery Index, Patient Expectations and Satisfaction With Prenatal Care Instrument in Pregnant Patients With COVID-19

The aim of this study is to provide optimum care to postoperative patients diagnosed with COVID-19 (after cesarean) and to help them with recovery, to determine and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with COVID-19

Exclusion Criteria:

* Patient giving Preterm Labor
Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]

This research aims to confirm that the therapeutic effect of EMDR is associated with changes in the interaction between cognitive function and emotional stimuli in PTSD patients compared to a controlled therapy in a randomized, single-blind study.On the other hand, this study aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a control therapy.

This investigation would improve the understanding of the mechanisms of action of the EMDR, still unknown to date.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with PTSD according to DSM 5 criteria (APA 2013) related to a single traumatic event,
* Aged 18 to 65 years,
* Signed informed consent.
* Patient with social security affiliation or State Medical Aid (AME)

Exclusion Criteria:

* Neurological disorders
* No other major psychiatric disorders than PTSD (DSM 5)
* Severe and/or unstable somatic pathologies,
* Patient not affiliated with social security,
* Patient hospitalized under stress in psychiatric care at the decision of the state representative or in psychiatric care at the request of a third party,
* Patient under guardianship,
* Patient participating in parallel with other biomedical research,
* Change of antidepressant during the last three months,
* Patient not fluent in French
* MR-specific criteria for not inclusion:
* women of childbearing age without effective contraception or a positive pregnancy test,
* patients carrying pacemakers or electrical or electronic devices, clips or metal prostheses,
* subjects with neurological disorders, cerebral abnormalities or suffering from claustrophobia.
A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients

The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.


Eligibility Criteria:
Inclusion Criteria:

* More than 19 years old
* Those who meet the fasting serum lipid levels along table
* Those who are under 350 mg/dL of TG level when fasting

Exclusion Criteria:

* The patient of acute arterial disease
* The patient of severe heart failure(NYHA class III or IV)
* Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders
* Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later)
* Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
* Fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (HMG CoA reductase inhibitors) in patients with muscle -related adverse drug experience of the system
* Drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( Crohn's disease , ulcers , acute or chronic pancreatitis , etc. )
* Patients with history of malignancies including leukemia and lymphoma within the past five years
* If severe renal impairment or in patients with impaired liver and hematological findings following the same
* Patients who have participated in another clinical trial within the previous 30 days or Prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient IND
* Those having a known hypersensitivity to hyperlipidemia treatment
* Patients with hypersensitivity or allergy to cruciferous plants
* Patients with a history of drug or alcohol abuse within the last 12 months
* Female patients of childbearing age
* In the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in Section 15
* Patient who are inappropriate by investigator's decision
Evaluation of Cessation Preferences of Menthol Smokers

The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified as African American or Black;
* Aged 18 years or older;
* High school graduate or GED;
* Smoking at least 10 cigarettes daily for the past year;
* Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;
* Good physical health (no unstable medical condition);
* No contraindications for nicotine inhaler or gum use, such as mouth sores or significant dental or jaw problems;
* Stable, good health.

Exclusion Criteria:

* Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
* Currently using other tobacco or nicotine products other than cigarettes;
* Pregnant or nursing.
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).


Eligibility Criteria:
The main inclusion criteria include but are not limited to the following:

* Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
* Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations
* Cohort BI: VHL Disease-associated tumors:

  * Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis
  * Must be ≥18 years of age
* Has a life expectancy of at least 3 months

The main exclusion criteria include but are not limited to the following:

* Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan
* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* Any of the following: A pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure
* Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention