cyrilzakka/clinical-trials huggingface dataset:
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.


Eligibility Criteria:
Left Sided Impella

Inclusion Criteria:

* Left-sided Impella with bicarbonate in the purge

Exclusion Criteria:

* Known LV thrombus

Right Sided Impella

Inclusion Criteria:

* Right-sided Impella with bicarbonate in the purge

Exclusion Criteria:

* Known pulmonary thromboemboli
* Known DVT
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
2. No previous systemic anti-tumor treatment;
3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;
4. Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
5. ECOG: 0-1;
6. Adequate organ and bone marrow function;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
2. Prior therapy as follow:

   1. Anti-PD-1 or anti-PD-L1;
   2. Any experimental drugs within 4 weeks of the first dose of study medication;
   3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;
   4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
4. Subjects with any active autoimmune disease or history of autoimmune disease;
5. Pregnancy or breast feeding;
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.

Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rosacea
* Good health with the exception of rosacea
* Papsules and pustules minimum and maximum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of rosacea
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.

The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life.


Eligibility Criteria:
Key Inclusion Criteria:

1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Key Exclusion Criteria:

1. Uveal melanoma
2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
6. Participants with a history of myocarditis
7. Adolescent patients (≥12 to \<18 years old) with body weight \<40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Cognitive Training to Promote Brain Health: Implementation and Engagement

Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Dementia is the most devastating consequence associated with age-related cognitive decline. Recent studies indicate that improving cognition by means of intensive computerized brain training can mitigate some aspects of agerelated cognitive decline, and may even have a role in preventing or delaying dementia onset. Critically, the capacity of a given individual to improve their cognitive performance after training is fundamentally related to engagement with the exercises. Currently, little is known about how to apply intensive computerized cognitive training effectively in the health system, ensuring engagement and best progress. This project aims to tackle this challenge by developing, applying and testing personalized approaches to implement cognitive training in daily life of older adults that were recently evaluated at Memory Clinics and their care partners. The community readiness approach will be implemented using semi-structured interviews, conducted with subjects that may be interested in cognitive training, key informant, and key stakeholders. Using this information, the investigators will design an individualized training program and follow up its application in a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3 months, in computerized cognitive training. Subjects will be assessed after completion of the intervention for training adherence and individual gains on the computerized exercises. In order to gain insight about regional specificities of the approach the investigators will perform a parallel project using the same methodology in Brazil. This project is expected to inform the future implementation of cognitive training in public health policies for older adults.


Eligibility Criteria:
Inclusion Criteria:

* Being evaluated at a memory clinic in the last year, or be the care partner of a person evaluated at a memory clinic
* Adequate visual and auditory acuity to allow practice on the computerized training exercises
* Physical ability sufficient to allow performance of the computerized training exercises
* Provide signed and dated informed consent form.
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Any medical condition that precludes performing the computerized training exercises
* Advanced dementia.
N-of-1 Trials In Children With Hypertension

The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control compared to usual care. This trial aims to advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.

Pediatric hypertension, a growing problem, often requires prescription of antihypertensive medication. Pediatric hypertension specialists lack an evidentiary base on which to establish definitive clinical practice guidelines for first-line therapy. Significant practice variation is an unsurprising consequence. Routine choice of the same first-line therapy for most patients with hypertension, absent testing other options, may delay correction of blood pressure for months or years. Failure to incorporate patient preferences in medical decision-making may also contribute to decreased patient satisfaction and adherence.

Large parallel-group, comparative effectiveness trials are likely not on the horizon for this population. Moreover, heterogeneity of treatment effects would minimize the generalizability of such a trial to all patients.

This is a parallel-group, randomized clinical trial to compare the n-of-1 trial approach to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.

Eligibility Criteria:
Inclusion Criteria:

* treating physician determines that pharmacologic therapy is indicated for treatment of hypertension
* ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment

Exclusion Criteria:

* age \< 10 years
* resistant hypertension (requiring ≥ 3 drug therapy)
* absolute contraindication or allergy to any of the tested drugs.
IS Reduces Rib Fracture Complications

The incentive spirometer (IS) is a mechanical device that helps lung expansion. It is commonly used to prevent postoperative lung atelectasis and decreased pulmonary complications in patients who received cardiac, lung, or abdomen surgery.This study aimed to explore the effect of the IS on the improvement of lung function and decrease in pulmonary complication rate in rib fractures patients.

Adult patients (\>18 years old) seen at our institution between June, 2014 until May, 2017 with traumatic rib fractures were included. For inclusion, a patient had to have at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan. We excluded patients with unconsciousness, history of chronic obstructive pulmonary disease, asthma, or an Injury Severity Score (ISS) ≥ 16. Patients were divided into two groups using a randomized envelope technique: in the study group, patients were advised to use the IS and in the control group patients did not received the IS. All patients were managed with the same oral analgesic protocol. A CXR was obtained on the 1st and 5th day of admission and performed by a radiologist. The Pulmonary Function Test (PFT) was administered on the 2nd and 7th day of admission and performed by a pulmonologist. A numeric rating scale (NRS) was used to define the severity of chest pain on the 1st and 5th day of admission.

Eligibility Criteria:
Inclusion Criteria:

* at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan

Exclusion Criteria:

* unconsciousness,
* history of chronic obstructive pulmonary disease
* asthma
* Injury Severity Score (ISS) ≥ 16
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years hospitalized patient who needs colistin for therapy of nosocomial infection

Exclusion Criteria:

* pregnant woman
* lactating mother
* allergy to ascorbic acid
* receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
* received radiocontrast media within 1 week
* renal stone
* G-6-PD deficiency
Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)

This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).


Eligibility Criteria:
Inclusion Criteria:

* Female participants are of non-child-bearing potential.
* Male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study.
* Participant has an International Classification of Sleep Disorders diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome.
* Participant has excessive daytime sleepiness.
* Participant has been using nCPAP treatment for at least 2 months.
* Participant reported total sleep time of \>6 hours on at least 4 out of 7 nights each week
* Participant is willing to stay at the sleep laboratory for 5 overnight stays.
* Participant is willing to limit caffeine and alcohol consumption during the study.
* Participant has a valid driver's license in the past 5 years and has had at least 1 year of driving experience within the past 3 years.
* Participant's regular bedtime is between 9:00 p.m. and 12:00 a.m.

Exclusion Criteria:

* Participant has a history of cancer.
* Participant has any history of a significant neurological disorder.
* Participant has moderate or severe persistent asthma.
* Participant has a history of any of the following sleep disorders: narcolepsy, primary insomnia, Circadian rhythm sleep disorder, shift work sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, rapid eye movement (REM) behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or restless leg syndrome.
* Participant consumes more than 10 cigarettes a day or routinely smokes during the night.
* Participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab abnormality or circumstances that might confound the results of the study, or interfere with participation for the full duration of the study.
Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.

Although, to this date, there have been a number of human placental studies that concerned the evaluation of placental 3 dimensional power Doppler vascularization with the use of VOCAL technique, but there was no one in which placental vasculature has been compared between the sonobiopsy and whole placental volume.

Eligibility Criteria:
Exclusion criteria:

* multiple pregnancy,
* abnormal (\> 3mm) nuchal translucency from 11+0 to 13+6 weeks of gestation,
* the fetal or neonatal structural or chromosomal anomaly,
* inadequate localization of the placenta (placenta praevia),
* self-reported drugs, alcohol, caffeine or nicotine abuse,
* exposed to circulatory medication (oxerutins, calcium dobesilate)
* or not signing the consent form.
* If the mother suffer from er systemic disease (e.g. diabetes, autoimmune disease, vasculitis, haemophilia, thrombophilia, HIV infection, etc)

Inclusion clriteria:

* single pregnancy
* healthy pregnant women
* no anatomical alteration of fetus
* no genetical abnormality of fetus
Elosan Efficacy Study (EES)

The "Elosan Cabin" is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage in patients with chronic pain, especially those with rheumatic diseases. Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.

Included in the study can be all persons suffering from chronic pain, as it is often the case with rheumatic disease or traumata. The Elosan therapy to be investigated aims to treat chronic pain by applying an electrical charge to the body surface and by disruption of positive bio-feedback to restore physiological reflex relations between the periphery and the central regulation. The electric charge is created by a generator which can produce an electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a closed cabin and is spread over the entire body surface.

A total number of 42 patients will be included into this trial in order to show a statistically significant reduction of pain compared to reduction of pain in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* adults, age ≥ 18 years, male or female patients
* History of pain ≥ 6 months
* Suffering from chronic pain, either reumatic pain or pain caused by traumata
* Intensity of pain rated ≥ 50 mm on VAS pain

Exclusion Criteria:

* Untreated thyroid disease
* History of seizure disorder (epilepsy)
* History of or current psychosis
* Women who are pregnant, breast feeding or intending to become pregnant
* Patients who are currently participating in other studies or have participated in other studies within the last 30 days
* Patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial
* Patients with an electric or electronic implant.
Comparative Effect of Scaphoid, Hamate Mobilization and Neural Mobilization in Patients With Carpal Tunnel Syndrome

To rule out the effects bone mobilization and neural mobilization in Carpal Tunnel Syndrome.

A Randomized control study of 3 month period will be conducted at Riphah International University Faisalabad. Patients will be enrolled by purposive sampling based on pre-defined inclusion and exclusion criteria. Patients were randomly allocated into groups. The Patients of group A will receive scaphoid, hamate mobilization with kinesio taping and group B will receive neural mobilization with kinesiotaping. Group A will receive neural mobilization and Group B will receive scaphoid and hamate moilization. The Patient's outcome will be distinguished by Visual Analogue scale and the data of the patients will be noted pre-treatment and post-treatment. Informed consent will be taken from each patient. Data entry and analysis will prepare through Statistical Package of Social Sciences Version 20.

Eligibility Criteria:
Inclusion Criteria:

* At median nerve distribution, felt pain and parasthesia Phalen sign positive Tinel sign positive Increase symptoms throughout the night Symptoms that continue for at least 3 weeks

Exclusion Criteria:

* Pregnancy Diabetes Thyroid disease Rheumatoid arthritis Thenar muscle atrophy Weakness of thenar muscle Hand surgery/ bone fracture
Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Fitzpatrick Skin Type V and VI
* Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
* Individuals willing to undergo a washout period of 3 days.

Exclusion Criteria:

* Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
* Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.