cyrilzakka/clinical-trials huggingface dataset:
The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.

Spinal anesthesia has a shorter time to onset than epidural anesthesia, and the amount of local anesthetic administered is lower than that of epidural anesthesia, resulting in less systemic toxicity and superior block effect.

However, there are disadvantage that it is difficult to control the block height and the incidence of hypotension is high.

On the other hand, epidural anesthesia has the advantages of less sudden hypotension due to slow autonomic blockade, but it has a disadvantage that sensory nerve and motor nerve block time is delayed compared to spinal anesthesia.

The degree of nerve block for cesarean section surgery requires a high level of anesthesia above the T6 level, so the frequency of hypotension is high due to rapid sympathetic block after spinal anesthesia.

In this respect, hemodynamically stable epidural anesthesia is preferred when performing anesthesia for cesarean section.

The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.

Exclusion Criteria:

* Fetal distress requiring fast delivery.
* Patients with hypersensitivity, allergic response, resistance to the drugs used in this study (fentanyl, ropivacaine, lidocaine).
* Patients who is not possible for regional anesthesia
* Patients who refused to participate in this study.
* Patients who cannot read or understand the agreement.
* Patients whose weight is less than 50kg or exceeds 100kg.
AMR of Streptococcus Pneumoniae Carriage Strains

This study looks at the usage of human antibiotics for treatment of animals in Bangladesh.


Eligibility Criteria:
Inclusion Criteria:

* Bangladesh location

Exclusion Criteria:

* none
Effects of Aromatherapy on Childbirth

Aromatherapy is a form of complementary medicine that uses scented materials known as essential oils for the purpose of affecting a person's health or mood. Although aromatherapy has been used in childbirth for centuries, there are no high-quality studies examining whether the treatment works.

Methodology

We would like to see if aromatherapy affects a woman's experience of childbirth by lowering associated anxiety and pain. Consenting participants will be randomly allocated to one of these groups:

1. Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense)
2. Non-essential oil (baby oil)
3. Standard maternity care

We will gather primary data, e.g. if she's been in labour before and her awareness of complementary medicine. We will also conduct the Spielberger State-Trait Anxiety Inventory with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions to keep the swab with the oil on it near to her. She can also put more oil on the swab as she requires.

Postnatally, data will be collected from her notes regarding pain relief used, duration of labour, augmentation of labour, and any other medical interventions of note. We will also complete the anxiety scale with her once more. Before her discharge we ask the mother for any comments regarding her experience of the labour. The results from all three cohorts will then be compared. There will also be opportunity for the midwife to make any comments regarding his/her perception of the participant's labour. Finally we will hold a focus group with midwives regarding the practicalities for implementation of aromatherapy in maternity care


Eligibility Criteria:
Inclusion Criteria:

* women in labour and expecting a normal delivery,
* aged \> 16 who are able to make informed consent;
* singleton pregnancy;
* spontaneous or induced labour onset;
* prior to elective or emergency caesarean section.

Exclusion Criteria:

* preterm labour;
* pool births;
* scheduled caesarean section.
This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.

This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized).
* Has a Pfizer-BioNTech mRNA bivalent COVID-19 or influenza vaccine (any type) between 31 August 2022 and 30 January 2023 (earliest vaccine is index date).
* Aged \>=18 years on the index date
* 365 days of continuous enrolment prior to index date

Exclusion Criteria:

* Patients with a second dose of any type of bivalent mRNA COVID-19 or flu vaccine, disenrolled or died within 14 days following the first dose.
* Has prior COVID-19 diagnosis (U07.1, any setting, any position) within 90 days (per CDC guidance on length of time before receiving a vaccine) before and on index.
* Has influenza vaccine between 01 August -30 August 2022 (before study period).
* Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).
Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

This extension study is to assess the long-term safety of EC-MPS


Eligibility Criteria:
Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

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The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel

Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.

One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.

Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in cancer patients.

The investigators aim to prospectively study the association between the plasma level of alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.

Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.

One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein

Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in non small cell lung cancer patients.

The investigators aim to prospectively study the association between the baseline plasma level of alpha 1 acid glycoprotein (measured on the first day of the first cycle of docetaxel) and the outcome (response rete, progression free survival, overall survival) of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, stomach cancer, prostate cancer, and bladder cancer.

Eligibility Criteria:
Inclusion Criteria

* patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin
* patients must be treated with docetaxel based chemotherapy
* patients must sign an informed consent form

Exclusion Criteria

* patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin
* patients treated with chemotherapy other than docetaxel
* patients that did not sign an informed consent form
Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

This study will develop a clinical decision support tool that assists primary care providers in carrying out substance use interventions, and then compare (in Phase 2) two clinical scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention received) and changes in drug use at 3 and 6 months, among primary care patients. Investigators will develop the Clinical Decision Support (CDS) component and then test the full SUSIT approach, using mixed methods to assess its acceptability and adoption, and gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a secondary study site to avoid contaminating the SO condition.

This study has 3 specific aims:

Aim 1 is to develop clinical decision support that assists primary care providers in carrying out a brief intervention.

Aim 2 is to assess the impact of the SUSIT on dose of substance use brief intervention received by patients.

Aim 3 is to gather preliminary evidence on the efficacy of the SUSIT approach for reducing moderate-risk drug use.

Eligibility Criteria:
Inclusion Criteria:

* Substance use screening results (collected using the tablet-based screening tool) indicating current moderate risk drug use, based on a substance specific involvement score (SSIS) indicating current (past 3 months) use of at least one drug with a moderate risk level (SSIS 4-26), in the absence of any high-risk drug or alcohol use (SSIS 27+);
* Presenting for visit with a participating PCP

Exclusion Criteria:

* Prior participation in the study (i.e. participation in the SO study phase would preclude participation in the SUSIT phase);
* Attending a formal addiction treatment program (not including informal treatment such as Alcoholics Anonymous, Narcotics Anonymous), in the past 3 months;
* Pregnant (based on self-report).
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia

The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Plan: We will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for LID in PD.

Methods: Eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. Each treatment sequence includes placebo and buspirone interventions. After randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. At the end of each two week study drug period, the participant will then have a study visit at the VA Portland Health Care System that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of LID.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosis
* Currently taking a levodopa containing medication for Parkinson's disease
* Mild to Severe dyskinesia
* Currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia.
* Stable medication regimen for at least 4 weeks prior to study.

Exclusion Criteria:

* Currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation.
* Not able to follow verbal commands
* Not able to stand unsupported for at least 60 seconds
* Not able to answer a patient questionnaire about their symptoms of Parkinson's disease and dyskinesia.
* Have proprioceptive deficits.
* Have a history of hepatic impairment
* Currently have severe renal impairment
* Currently have any other medical or psychiatric diagnosis that would preclude their ability to safely participate in the study.
* Significant cognitive impairment
* Pregnancy
* Breast-Feeding
* Unable to swallow study drug (capsule)
A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).

Study Hypothesis:

In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(\> 30% reduction after Duloxetine treatment).


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80
* Physician diagnosis of OA in hip, knee or spine.
* Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain \>5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs. \[This will identify an OA group with significant psychological distress and a desire for treatment.\]
* Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.

Exclusion Criteria:

* Cannot read and write English
* Significant cognitive impairment
* History of psychosis or mania
* Current suicidal ideation

  * Current substance abuse or dependence
  * Current use of opioids or any antidepressant medication
  * Use of investigational drug within the past month
The Effects of Tele-rehabilitation Interventions in Parkinson's Patients

Parkinson's Disease (PD) is the most common neurodegenerative movement disorder. The main motor symptoms of PD are tremor, rigidity, bradykinesia, and postural instability. Current treatments of the disease provide control of motor symptoms but do not change its development. Parkinson's patients should receive regular rehabilitation as part of their treatment. Telerehabilitation (TR) practices and studies examining the effectiveness of these practices are needed in order to reduce the impact of the current pandemic period and environmental and personal causes in accessing rehabilitation services.

In this thesis, in order to examine the effects of two different TR methods on physical parameters and activities of daily living in Parkinson's patients, Parkinson's patients who are eligible the inclusion criteria will be randomized according to the row of application and divided into 2 groups. Evaluations to determine the functionality, activities of daily living, falling activity, quality of life and fatigue level will be applied both groups. One group will be applied video exercise program prepared individually via TR system, and the other group will receive an exercise brochure via the TR system and patients will be asked to do the exercises 3 days a week for 8 weeks. Then the initial evaluations will be repeated. It is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels with exercise training to be applied to people with Parkinson's.

Investigators think that present study not only will contribute to the field of TR applications in PD, but also will provide access to rehabilitation services and help control symptoms of Parkinson's patients who cannot go to hospital, rehabilitation centers and cannot access rehabilitation services at home.

Hypotheses:

H0-TR applications have no effect on the level of independence in physical parameters and activities of daily living in individuals with PD.

H1-TR applications have positive effects on physical parameters and independence in activities of daily living in individuals with PD.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Parkinson's disease at least 1 year ago by a neurologist
* Hoehn and Yahr score ≤3
* Have an internet infrastructure where the system can be accessed at home
* Not participating in a standardized physiotherapy program in the last 3 months

Exclusion Criteria:

* Presence of blurred or low vision problems
* Hearing and speech impairment affecting participation in the system
* Epilepsy
* Presence of pregnancy
* Having any cognitive problems that prevent using the system
Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients

The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>18 years of age at time of consent.
2. Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 \< 50% predicted and FEV1/FVC ratio \< 70% predicted.
3. Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration

Exclusion Criteria:

1. Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
2. Subject has respiratory rate at rest \> 28/min
3. Subject requires \> 5 L/min nasal O2/min to maintain O2sat \> 90%
4. Subject has severe dyspnea at rest
5. Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
6. Subject has history of pneumothorax secondary to lung bullae.
7. Subject is too cognitively impaired to give subjective ratings for visual analog scale
8. Subject has sensitivity or an allergy to lidocaine
9. Subject has known history of oxygen intolerance.
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.


Eligibility Criteria:
Inclusion Criteria:

1. Has had knee pain in study knee lasting at least 3 months
2. Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.

Exclusion Criteria:

1. Current tobacco use or has quit within 3 months of study enrolment.
2. Substance abuse history.
3. Diabetes mellitus, HbA1c\>8
4. High surgical risk due to pre-existing conditions.
5. Currently pregnant or has plans to become pregnant prior to surgery.
6. Active infection or history of chronic infection in study knee.
7. Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation. (Meniscal tears, including chronic, are acceptable if no repair is required)
Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Charcot-Marie-Tooth disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use.

Through this research, researchers hope to identify future treatments or even cures for Charcot-Marie-Tooth disease.

Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. These "pluripotent" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly.

Additionally, researchers perform genetic testing to learn more about DNA, a material in most cells that contains instructions for the body's development and functions (such as traits like eye color and risk of certain diseases). A piece of DNA that determines the specific role of a cell is called a "gene." If the instructions in a gene are abnormal, this can lead to disease.

Participation in the study involves: (1) completion of health questionnaires, (2) providing a skin and/or blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future followup to provide additional information or learn about other research studies.

This study is not a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 5 years or older.
* Diagnosis of Charcot-Marie-Tooth (CMT) disease or healthy controls.
* Adults must provide written informed consent unless physical limitations preclude signing.
* Minors undergoing skin collection for research purposes must have a CMT diagnosis and must participate with parent/guardian consent.
* Minors undergoing blood and/or saliva collection for research purposes or who transfer biological samples from a procedure outside the research may have a CMT diagnosis or serve as a healthy control and may participate with parent/guardian consent.

Exclusion Criteria:

* Wards of the state.
* For prospective skin samples: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.
* For prospective blood samples: coagulation disorder or other medical conditions that increase the risks associated with blood collection.
* For all prospective sample collections: Subjects who refuse to adhere to NYSCF's and/or a collaborating site's safety protocols will be excluded. Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter of blood will be excluded due to increased risk of infection.