cyrilzakka/clinical-trials huggingface dataset:
Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.

Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.

Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology \& Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.

Patients and methods:

Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.

Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.

Eligibility Criteria:
Inclusion Criteria:

* all patients with clinical diagnosis of vitiligo

Exclusion Criteria:

* children =or \<2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
New Modality for Post Covid Syndrome Patients

Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.


Eligibility Criteria:
Inclusion Criteria:

* age will be ranged from 30 to 40 years
* patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
* patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
* patients will be recruited after 2 weeks post the negative pcr
* patients who want to participate and complete the study till the end

Exclusion Criteria:

* patients with photosensitivity
* pacemaker plantation pregnant women
* BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)

The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30\<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.

1. There will be two groups of patients.

   1. The first group (n=167) will receive weight management intervention during up to four months prior to IVF treatment.The group randomized to intervention will start an intensive weight reduction plan. The aim of the weight reduction is to reach as close to normal BMI (\<25.0 kg/m2) as possible during a time of approximately 4 months. The purpose of the dietary intervention is to create a negative energy balance to induce weight loss. The intervention starts with 12 weeks of a low calorie liquid formula diet (LCD) and thereafter, diet re-introduction and weight control stabilization until IVF treatment begins. Should the patient for some reason be unable to fulfil the LCD-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her IVF-treatment.
   2. The second group (n=167) will start their IVF-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. The group randomized directly to IVF-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle.
2. Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.

Eligibility Criteria:
Inclusion criteria

* Indication for IVF/ICSI for the couple
* Woman's age \>18\< 38 years at randomization
* First, second or third IVF/ICSI treatment
* BMI \> or = 30.0 \<35.0 kg/m2
* Willing to participate and to sign informed consent

Exclusion Criteria:

* Diabetes mellitus treated with insulin
* Oocyte or sperm donation planned
* Preimplantation genetic diagnosis (PGD) treatment planned
* Azoospermia known at randomization
* Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
* QEWP-R questionnaire indicating binge eating disorder for the woman
* Previous participation in the study
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Subjects must be 18 years or older at the time of signing the informed consent.

Exclusion Criteria:

* Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
* Subjects who have any other skin disease that may interfere with assessment of CSU or HS.
* Subjects who have an active infection or history of infection(s) as follows:

  1. Any infection requiring systemic treatment within 14 days prior to baseline.
  2. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
* Subjects with known progressed liver disease (Child-Pugh B or C)
Investigation of Plasma Mitochondrial DNA Level in Septic Patients

To determine the plasma levels of mtDNA in ICU department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. Plasma from control, septic and severe septic patients will be collected. The level of mtDNA and systemic cytokine will be measured.

Clinical protocol:

Patients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response.

Methods:

Plasma levels of mtDNAs were measured using real-time quantitative polymerase chain reaction. Levels of mtDNAs were compared among each group, and linear regression was used to assess the association between mtDNAs, IL-6, TNF a and IL-1b in patients with sepsis. The correlation between plasma mtDNA and severity, systemic inflammation and outcomes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sepsis and severe sepsis was according to the following guild-line. "Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012"

Exclusion Criteria:

* Patients lost following-up. Patients who refuse to sign the consent form.
Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone

Particle steroid drug such as triamcinolone has been used widely for epidural steroid injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone become only candidate drugs for ESI in Korea and the investigators are curious about the effectiveness and safety of both drugs due to limitation of information about comparison of two drugs in previous literature. So, this study aims to compare the effectiveness and safety of both drugs and our hypothesis is that there is no difference of the effectiveness between dexamethasone and betamethasone at 2 weeks after ESI.


Eligibility Criteria:
Inclusion Criteria:

1. patients with spinal pain (i.e.neck pain, back pain, or radiculopathy..)
2. patients with informed consent
3. visual analog scale (VAS) is five or more in 10-point scale at screening
4. sustained spinal pain, regardless of sufficient conservative treatment (i.e. oral medicine, physical therapy..)

Exclusion Criteria:

1. age of patient less than 19 years
2. relative contraindication of epidural steroid injection, as follows:

   * pregnant or breast-feeding state
   * uncontrolled coagulopathy
   * suspected of active infection state
   * uncontrolled diabetes mellitus
   * previous history of adverse event related to epidural steroid injection
Effect of a Higher Blood-pressure on Right Ventricular Function

Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. The current study is designed to evaluate the effect of a higher blood pressure on the RV function in post cardiac surgery patients.

Goal: To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine.

Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery patients admitted at the ICU.

Intervention:

* Group 1: (N=22): RVEF\<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
* Group 2: (N=22): RVEF \<20% and MAP≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
* Group 3: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
* Group 4: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.

Endpoints: Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF. Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV end-diastolic pressure, cardiac index, and fluid balance.

Eligibility Criteria:
Inclusion Criteria:

* post operative cardiac surgery patients, full sternotomy
* admission at ICU
* informed consent
* right ventricular monitoring by pulmonary artery catheter.
* RVEF \<30% + MAP ≤ 65mmHg

Exclusion Criteria:

* no informed consent
* acute surgery
* Off pump cardiac surgery
* Severe tricuspid insufficiency
* Allergy to norepinephrine
* Severe left ventricular hypertrophy with systolic anterior movement
* Chronic use of alpha-blockers
* Irregulair heart rhythm
* Surgical reasons to maintain a low blood pressure.
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.

Bilateral drainage is more physiologic and have more long patency than unilateral drainage.

There are two methods of bilateral drainage: Y-stent and side by side.

However there are no clinical data about comparing the effectiveness of these two methods.

Therefore the investigators want to compare the clinical outcomes of two methods:

Y-stent and side by side.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* patient who have obstructive jaundice (bilirubin \> 2.0mg/dl) due to hilar malignancy

Exclusion Criteria:

* patients with endoscopic retrograde cholangiogram is not possible
* bleeding tendency (PT INR \> 1.5, platelet \< 50,000)
* poor general condition (ECOG 3-4) or cardiopulmonary deterioration
* pregnancy
Transvaginal NOTES Sleeve Gastrectomy

This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.


Eligibility Criteria:
Inclusion:

1. Diagnosis of morbid obesity BMI \> 40
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

Exclusion:

1. Pregnant women
2. BMI \< 40
Cold Plasma to Treat Hair Loss

Self applied cold plasma activated medium used for androgenetic alopecia


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild-to moderate androgenetic alopecia
* ability of applying treatment regularly
* ability to keep in-person follow-up appointments

Exclusion Criteria:

* any inflammatory scalp condition
* starting or discontinuing any hair loss treatments within 6 months of start date
* allergy to any components of the carrier solution
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
* No evidence of metastatic disease
* No prior treatment
* Adequate organ function
* Adequate pulmonary function (FEV \>= 1.0L or predicted FEV \>0.8L)

Exclusion Criteria:

* Metastasis
* Prior treatment
* Malignant pleural or pericardial effusion
* Peripheral neuropathy \>= grade 2
Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS

The study will investigate the influence that extravascular lung water index (EVLWi) could have on the efficacy and persistance of efficacy of prone position in patients with acute respiratory distress syndrome.

Prone position will increase blood oxygenation in 75% of the cases and will be persistant in half of the cases. Unfortunately, no clinical criteria has been found correlated with efficacy. The quantity of lung edema, with increased lung weight, could be a determinant factor of efficacy and the persistance of the efficacy. EVLWi, assessed with the PiCCO2 device, reflects the quantity of fluid accumulated in interstitial and alveolar spaces.

The hypothesis is that patients with higher EVLWi will have less efficacy of prone position in oxygenation and also that the beneficial effects of prone position will last shorter compared to patients with lower EVLWi.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Presence of acute respiratory distress syndrome
* Decision to perform prone position according to the physician in charge of the patient
* Hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Allemagne)

Exclusion Criteria:

* Absence of affiliation to the French Sociale security
* Patient under a tutelage measure or placed under judicial protection
* Known pregnancy
* Currently receiving ECMO therapy
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer

This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.

PRIMARY OBJECTIVE:

I. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.

SECONDARY OBJECTIVES:

I. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11.

II. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET.

III. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms.

OUTLINE:

Patients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.

After completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee \[AJCC\] 8th edition)
* Patients undergoing FDG-PET scan as standard of care testing.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing female participants
High Definition Neuromuscular Stimulation in Tetraplegia

The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.

Spinal cord injury (SCI) is an insult to the spinal cord resulting in a change, either temporary or permanent, in its normal motor, sensory, and/or autonomic function. It is estimated that the annual incidence of spinal cord injury (SCI), not including those who die at the scene of the accident, is approximately 40 cases per million population in the U. S. or approximately 12,000 new cases each year.

The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants. This study will plan to enroll up to 15 subjects who have been diagnosed with tetraplegia. The total duration of the study is expected to be about 18 months, and each participant is expected to be on the study for about 6 months.

The study design will consist of the following two (2) phases listed below. I. Baseline assessment and calibration (approximately 1 month) II. Testing motions: pre-sequenced and EEG-triggered motions; further calibration as needed (approximately 5 months)

Phase I - Baseline

* Medical history review
* Physical and neurological exam
* EMG
* Fit and calibrate external stimulator: The Battelle Neuromuscular Stimulator will be setup and calibrated to evoke wrist and hand/finger movements.

Phase II - Testing Motions After the Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.

Eligibility Criteria:
Inclusion Criteria:

* Must be 21 years or older.

  * Must be tetraplegic (C4-6 ASIA A)
  * 12 months post injury and neurologically stable
  * Participant is willing to comply with all follow-up evaluations at the specified times.
  * Participant is able to provide informed consent prior to enrollment in the study.
  * The participant is fluent in English.

Exclusion Criteria:

* No active wound healing or skin breakdown issues.

  * No history of poorly controlled autonomic dysreflexia.
  * Other implantable devices such as heart/brain pacemakers
  * Subjects who rely on ventilators