cyrilzakka/clinical-trials huggingface dataset:
Er:YAG Laser for Treatment of Enlarged Pores

To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores.

* Enlarged pores are caused by multifactorial factors such as sex, genetics, aging, etc.
* The gold of the treatment is to recollagenesis of the dermis and resurfacing of the epidermis.
* Modalities that have been proved on their efficacy for enlarged pores treatment included topical retinoic acid, chemical peeling, intense pulsed light, radiofrequency device, laser such as Q-switched and Long Pulsed Neodymium-Doped Yttrium-Aluminum-Garnet (Nd:YAG) 1,064nm, Long pulse duration pulsed dye laser 595nm, etc.
* Er:YAG laser is an ablative laser which creates both recollagenesis and resurfacing. It ha been proved to be safe and effective in the treatment of atrophic acne scar.
* However, the efficacy of this laser for enlarged treatment has not yet been established.

Eligibility Criteria:
Inclusion Criteria:

* Visible enlarged pores on both sides of the face
* Fitzpatrick skin type 3-5

Exclusion Criteria:

* Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
* Patients who have photosensitive dermatoses
* Pregnancy and lactation woman
* Patients with wound infections (herpes, other) on the day of treatment
* Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
* Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Diet treatment only for at least two weeks
* Body mass index (BMI) between 22-34 kg/m2 inclusive
* HbA1C between 6.5-12.0% inclusive
* Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
* Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)

Exclusion Criteria:

* Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
* History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
* Impaired renal function, serum creatinine greater than 150µmol/L
* Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
* Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
* Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
* Patients who had a significant history of alcoholism or drug/chemical abuse
Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.

Eligibility Criteria:
Inclusion Criteria:

1. World Federation of Neurology modified El Ecorial criteria for diagnosis of patients with laboratory support probable, clinically probable, or definite sporadic and familial amyotrophic lateral sclerosis (ALS)
2. Age 18 to 80 years old
3. ALS duration no longer than 18 months(from day of onset)
4. Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea, orthopnea and respiratory insufficiency ≥3）
5. Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height and age
6. According to brain function AI analysis in accordance with depressive EEG characteristics
7. Women and men of childbearing potential should use medically acceptable contraception
8. Voluntarily participate, and sign an informed consent form

Exclusion Criteria:

1. Patients with dementia or severe neurological, psychiatric or systemic disease that is poorly controlled or may interfere with the conduct of the trial or the results of the trial
2. Pregnant women and lactating women
3. Suicide attempt or attempted suicide
4. Combined with other neurological diseases similar to ALS symptoms, or affecting the evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar spondylosis, dementia, etc.
5. Patients with history of spinal surgery after ALS onset
6. ALT or AST \> 2 times ULN，creatinine clearance \< 60 mL/min/1.73m2 (MDRD)
7. Patients who are allergic to the investigational product
8. Having participated in other clinical studies within 3 months before randomization
9. Patients that the investigator considers unsuitable for participation in the study
Efficacy and Safety of Deep Brain Stimulation (DBS) of the Pallidal (GPi) in Patients With Tardive Dystonia

The purpose of this randomized, double blind, multi-center study is to assess the efficacy and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.

Deep brain stimulation (DBS) has been established as a new reversible, neurosurgical therapeutic option for patients suffering from disabling neurological movement disorders such as essential tremor and Parkinson´s disease. Recently, deep brain stimulation has been successfully applied in patients with primary generalized and segmental dystonia. Additionally, a number of case reports suggest that pallidal deep brain stimulation may also improve tardive dystonia, which may for instance result from the intake of neuroleptics and which is notoriously difficult to treat medically. The present study will investigate the effects of pallidal DBS using a double blind, randomized design (sham- versus verum-stimulation within a 3-months interval post implantation of the electrodes).

Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30%. However, in a recent study (Damier et al., Archives of General Psychiatry, 2007), 10 out of 10 showed a successful outcome of approximately 50% decrease on the extrapyramidal symptoms rating scale score. The exact one- sided lower 95% confidence limit would be 0.794 for this result. If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82% against a placebo effect of 30% success rate. For a placebo effect of 25% one needs 16+16 patients and for the placebo effect of 20% one needs 12+12 patients. We thus decided to reduce the sample size to 36- 32- 24 patients. It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above. The local ethical committee has approved this.

Eligibility Criteria:
Inclusion Criteria:

* Operational criteria for tardive dystonia for \> 18 months after cessation of neuroleptic exposure
* 18-75 years
* Relevant functional impairment in daily living activities
* BFMDRS \> 8 or AIMS \> 16
* Informed written consent

Exclusion Criteria:

* PANNS \>60 (Schizophrenia)
* Hamilton-Score \> 18 (Depression)
* MATTIS-Score \<120 (Dementia)
* Preceding stereotactic neurosurgery
* Pronounced brain atrophy
* Increased bleeding risk
* Decreased immune status
* Botulinum Toxin treatment within the last 3 months
An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.

This is an open-label (identity of assigned study drug will be known) study of daratumumab for the treatment of participants with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD. Up to approximately 150 participants are to be enrolled. The study includes screening, treatment, and follow-up phases. Participants will receive daratumumab by intravenous infusion (28-day cycles) until disease progression, unacceptable toxicity, or other protocol-defined reasons. For all study drug administrations, participants will receive pre- and post-infusion medications for the prevention of infusion related reactions. Follow-up will continue until death, loss to follow up, consent withdrawal for study participation, or study end, whichever occurs first. The study will consist of 2 sequential parts (Part 1 and Part 2). The purpose of Part 1 is to select a dose and schedule for Part 2 of the study. Assessment of tumor response and disease progression will be conducted according to IMWG response criteria. Serial pharmacokinetic blood samples and a pharmacogenomic blood sample will be collected. Safety will be monitored throughout the study. At the end of the study, participants who are benefiting from treatment with daratumumab will have the option to continue treatment.

Eligibility Criteria:
Inclusion Criteria:

* Documented multiple myeloma according to protocol-defined criteria
* Evidence of disease progression on the most recent prior treatment regimen based on International Myeloma Working Group criteria
* Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
* Laboratory values and electrocardiogram within protocol-defined parameters at screening

Exclusion Criteria:

* Received daratumumab or other anti-CD38 therapies previously
* Nonsecretory multiple myeloma
* Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
* Exhibiting clinical signs of meningeal involvement of multiple myeloma
* Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
* Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
* Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Evaluation of Respiratory Heast Loss as a Physiologic Patient Monitor for Acute Care Medicine

To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.

Respiratory Heat Loss Measured in Joules Per Minute

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical procedures.

Exclusion Criteria:

* Severe pulmonary disease.
MightySat - Clinical Performance Comparison Study

This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 breaths per minute.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

* Younger than 18 years old, older than 45 years old
* ASA physical status of III, IV, and V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Refusal of male subjects to agree to shave hair off areas where sensors will be applied (neck)
* Excluded at Principal Investigator's discretion
A Comparison of Endoscopic Ultrasound Insertion Methods

Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon inflation while EUS insertion could result in decreased throat damage and pain, there is no data to back up. We designed a single center randomized pilot study to compare throat pain caused by EUS insertion with conventional vs balloon inflation method.

All patients who are undergoing EUS with radial type echoendoscope will be asked for an informed consent. Subjects will be randomized to conventional insertion arm and balloon inflated insertion arm. All patients will be sedated according to SNUH endoscopy center protocol. Conventional insertion will be done in conventional insertion group, and balloon inflation before the start of procedure will be done in balloon inflated insertion arm. After the EUS procedure is finished, subject will be moved to a recovery room. As soon as the subject is recovered from sedation, throat pain will be assessed in NRS scale and be recoreded. Information of insertion failure and balloon damage during insertion will be also collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 20 to 80
* Patients undergoing EUS with radial echoendoscope

Exclusion Criteria:

* Refuse to participate the study
* Refuse EUS procedure
An INtervention TO Improve MOBility of Older Hospitalized Patients

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers.

The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources.

This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status.

The multilevel intervention will target:

1. The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet.
2. The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility.
3. The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults.

In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback.

In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.


Eligibility Criteria:
Inclusion criteria:

* Admission to a general internal medicine (GIM) ward of a participating hospital
* Age ≥60 years
* Being ambulatory during the 2 weeks before admission (self-report)
* Living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission
* Ability to understand French or German
* Planned length of stay at least 3 days after enrollment
* For the pilot-study only: Possibility to start the study within 48 hours after admission to the GIM ward

Exclusion criteria:

* Medical contraindication to walk (e.g., wound not allowing loading weight)
* Wheelchair-bound
* End-of-life
* Severe psychiatric disorder (severe depression, schizophrenia, psychosis)
* Delirium (according to the Confusion Assessment Method \[CAM\])

Additional exclusion criterion for the pilot-study only:

- Dementia (defined as Mini-Cog \<3)

Additional exclusion criteria for the RCT only:

* Cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent
* Severe visual impairment
Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients

Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of patients at diagnosis is presented resectable because the diagnosis is often delayed making the 5-year survival of this disease globally less than 5%. An early diagnosis in these patients is currently not possible given the economic disadvantages of a population-wide screening. New evidences identify patients with new-onset diabetes as a subgroup of patients at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes. Our goal is therefore to assess the different impact of Pancreatic Cancer depending on Adrenomedullin values in patients with newly diagnosed diabetes mellitus.

The study is defined as prospective observational. The research project involves the recruitment prospectively for all consecutive patients aged between 45 and 75 years receiving a new diagnosis of diabetes, according to the criteria established by the American Diabetes Association (ADA) (fasting glucose greater than or equal 126 mg / dl, or random blood glucose greater than or equal to 200 mg / dl, or glycated hemoglobin greater than or equal to 6.25%). The recruitment will take place at the Sant'Andrea Hospital. The suitability of a subject to be included in the study will be evaluated by medical history, physical examination and any further investigations carried out by a medical researcher of the team, according to the inclusion and exclusion criteria. The research team will be multidisciplinary, translational, composed of medical specialists belonging to the departments of General Surgery, Internal Medicine, Diabetology and Occupational Medicine. An informed consent will be mandatory for the recruitment in the study. At recruitment Adrenomedullin serum levels will be recorded along with every relevant clinical and laboratory data. An annual telephone follow-up will be applied and if necessary the patient will benefit of an outpatient examination. A sample size of 440 patients will achieve 80% power to detect a statistically significant difference. The 3 years clinical follow-up will allow the detection of symptoms and signs that could be related to the presence of a pancreatic mass (jaundice, pain, weight loss), further investigations will follow in such cases to confirm Pancreatic cancer diagnosis and proceed to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 75 years
* Diagnosis of diabetes mellitus made within the two years preceding the date of observation (new onset diabetes)
* Adherence to the study documented the voluntary signing of an informed consent
* Availability to follow a telephone follow-up

Exclusion Criteria:

* Remote medical history (\> 2 years) positive for diabetes mellitus
* Previous history of malignancy
* Pregnancy
* Renal Failure
* Documented diabetic microangiopathy
* Sepsis
Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria

The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.

Chronic urticaria is a distressful disease, which negatively affects the quality of life. Pathogenesis isn't exactly clear, treatment is relatively palliative and results are usually suboptimal. 30-40% of the patients have autoimmune origin. Patients are forced to use immunosuppressive treatments which have systemic effects. Some of the treatments have effects as severe as the disease itself.

Mesenchymal stem cells (MSCs) are the most common used cells in clinical trials. These cells can provide efficient immunosuppression in severe conditions like immunosuppressive resistant Graft versus Host Disease. With this study at the first time and quite a different approach from conventional treatment, it will be tried an experimental treatment that used in the MSCs for the chronic autoimmune urticaria patients without of definitive treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with chronic autoimmune urticaria (at least six months before)
2. Patients who have \>20 and over of urticaria activity score \[according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines\].
3. Patients who capable of own daily findings record.
4. Patients who could not be controlled despite the use of a treatment agent in the fourth step for 3 months (according to EAACI / GALEN guidelines).

Exclusion Criteria:

1. Patients who have heart, liver or renal failure.
2. Patients who have epilepsy, cerebrovascular or ischemic attack.
3. Patients who have atopic dermatitis or another underlying itchy skin disease.
4. Patients who have parasitic infection.
5. Patients who have antibiotic allergy.
6. History of malignancy.
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

The DS Prime Taper EV dental implant system was recently launched on the implant market by Dentsply Sirona (York, PA, USA).

Dental implant systems are undergoing rapid evolution, ultimately driven by their broad therapeutic indications. As manufacturers strive to keep up with the demands of a growing market, designs are changing faster than clinical evaluation. This means that the time needed to assess medium- and long-term clinical outcomes before designs change again cannot be met.

Clinicians need to have a "real" analysis of the clinical performance of implants before using them. Therefore, reporting of results is necessary to avoid use in patients without proper practical checks even before the recommended 10- and 15-year follow-up periods.

The DS PrimeTaper implant has macro-design features that differ from its predecessor, the OsseoSpeed EV implant (AstraTech Implant System EV, Dentsply Implants, Mölndal, Sweden) with which they share a common surface and internal connection.

Its macro-design has been modified through the introduction of variable thread forms and a more pronounced taper, ultimately making it more aggressive in terms of cutting ability.

While its predecessor, the OsseoSpeed EV implant, has sufficient scientific support, this new system recently introduced on the market does not. All the scientific contributions that can be made will therefore be a first guide for the clinician who wishes to start using this dental implant system.

Eligibility Criteria:
Inclusion Criteria:

* All the patients whom received at least one DS Prime Taper implant.

Exclusion Criteria:

* When dental implant surgery is contraindicated.