cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries

The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

Exclusion Criteria:

* Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.
A Chinese Herbal Medicine for IBS-C

This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.

This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.Primary Objective: To determine the efficacy and safety of CDD-2105 granules for treating IBS-C.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years adults
* Fulfill the clinically diagnosed with IBS-C based on the ROME IV criteria
* Abdominal pain intensity: weekly average of the worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0 to 10 point scale (based on the 2-week E-diary in screening)
* CSBM ≤ 2 times/week (based on the 2-week E-diary in screening)
* Understand and be able to follow written and oral instructions in Chinese
* Provide informed consent
* Able to use and complete 2-week E-diary for screening

Exclusion Criteria:

* Drug-induced or secondary causes of constipation
* Use of medications and/or supplements that may confound the study outcomes (including but not limited to antibiotics, steroid, analgesic drug, neuromodulator, prebiotics, symbiotics, or probiotics)
* Clinically significant colonoscopy or sigmoidoscopy examination findings after the onset of symptoms for patients who (1) is ≥50 years old; and/or (2) has family risk of colon-rectal cancer or familial polyposis syndromes; and/or (3) has alarm symptoms within 6 months before screening (unintentional weight loss: \>10% in 3 months, blood in the stools not caused by hemorrhoids or anal fissures, fever of unknown origin, anemia)
* Clinically significant laboratory or imaging findings within 6 months before screening
* Recent history of mushy or watery stools within one month
* Allergic to Chinese herbal medicine or G6PD
* Abdominal surgeries within the past year (except laparoscopic appendectomy)
* Pregnancy, breastfeeding or plan to become pregnant with the study timeframe
* Any disease(s), condition(s) or habit(s) deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
* Any disease(s), condition(s) or habit(s) deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research, at the discretion of the investigators
The Translational Initiative to Map Epigenetics in Aging (TIME-A)

The Translational Initiative to Map Epigenetics in Aging (TIME-A) study aims to advance our understanding of the connections between epigenetics, lifestyle, demographics, and health and aging.

TIME-A is a longitudinal research initiative. Anyone who has ever taken an Index test registered through Elysium Health is eligible to participate. Participation involves answering questions that will be administered via a survey format. Research participants' survey responses will be combined with their epigenetic Index data with the primary aim of identifying the contributions of 1) environmental and lifestyle factors, 2) general health, and 3) medical history, on biological age. Exploratory aims include the development of epigenetic signatures that are predictive of health status, and exploring the relationship between epigenetically-derived health phenotypes and biological age. These findings will lay the foundation for personalized health recommendations using Index (including, but not limited to: workout routines, diets, supplement regimens, medications, lifestyle changes).

Eligibility Criteria:
Inclusion Criteria:

* All adults aged 18 and above
* Have registered at least one Index kit via the Elysium Health website
* Able and willing to provide digital consent to the Research Consent Form, and the TIME-A Research Subject Consent Form

Exclusion Criteria:

* Consent to participate not given
IP Peru, Bioavailability of Iron From Potatoes

To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Irish Potato (IP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron IP variety and a normal market level IP variety. The study is conducted in Peruvian women of reproductive age with marginal iron status.

The 40 women enrolled will consume test meals consisting of 500g steamed and mashed high iron Irish potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57 for a period of 10 days. The order of test meal type is random. A baseline blood sample will be taken on the first meal feeding day prior to consumption of any test meals, study day 15 (before switching to the other test meal IP variety), on study day 26 (14 days after completion of the first test meal period) and on Day 40 (14 days after completion of the second test meal period). Erythrocyte incorporation of the stable isotope labels will be measured in these blood samples using an ICPMS and will be used to calculate fractional and total iron absorption from the two different type of test meals.

Eligibility Criteria:
Inclusion Criteria:

1. Woman aged 18-25 years old.
2. Low/marginal iron status: serum ferritin (SF) ≤ 25 μg/L.
3. Normal BMI for age (18.5-25.0 kg/m2).
4. Weight less than 65 kg. We will give equal amounts of stable isotopes to each study participant and therefore need to set a limit on body weight in order to achieve measurable isotope enrichment in erythrocytes.
5. Willing and able to commute to the meal distribution/health centre site.
6. Able to understand and to sign written concept prior to trial entry.
7. Informed consent signed.
8. Prepared to use contraceptives for the duration of the study

Exclusion Criteria:

1. Severe anaemia Hb \<107.2 g/L (adjusted for meters above sea level)
2. Inflammation/infection (CRP \> 5 mg/100 ml).
3. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, and any other problem that will interfere with the study as determined by the screening visit and by self-report from the subjects.
4. Pregnant (urine test before entering the study) or breast-feeding.
5. Any medication or supplement which may impact iron metabolism.
6. Unwilling to discontinue vitamin and minerals supplements at least two weeks prior to the study start, as ascertained at the screening visit.
7. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation).
8. Subject who cannot be expected to comply with study procedures.
9. Presence of fever (\>37.5 °C) on the first study day
Comparative Effects of Different Stretching Protocols on Performance Enhancement in Racquet Sports.

This study intends to compare the effects of Static stretching Protocols with Dynamic stretching protocols on racquet sports players to find out how these protocols affect their performance.

In this study, two groups will be formed to find out the effects of static and dynamic stretching protocols on racquet sports players over a course of 6 weeks. One group is given the static stretching protocol, and the other group is given the dynamic stretching protocol, and at the end of the 1st, 3rd, and 6th weeks, readings are taken to compare the effects of these techniques on the performance of the subjects enrolled in this study. A total of 52 participants will be involved, and the groups will be divided into 26, 26 each. Data will be analyzed through SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Males.
* Age 20- 40 years.
* Amateur Active players with at least 1 year of regular experience.
* Free from any musculoskeletal injuries or conditions affecting participation.
* Willing to provide written informed consent.

Exclusion Criteria:

* Players with ongoing or recent (\<3 months) musculoskeletal injuries.
* Those with chronic conditions (e.g., arthritis, cardiovascular issues) affecting physical activity.
* Those suffering with any medical condition that affects their performance.
* Participants who are currently following a specialized stretching regimen outside regular squash warm-ups.
* Use of medications that could affect muscle function or perception during the Study.
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

OBJECTIVES:

Primary

* To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
* To determine the time to progression.

Secondary

* To correlate c-kit mutational status with response to therapy.
* To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
* Tolerability of imatinib.
* To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
* To correlate c-kit amplification status with response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
* History of primary mucosal or acral/lentiginous melanoma
* Histologically documented stage IV metastatic melanoma
* ECOG performance status 0,1, or 2
* Estimated life expectancy of 6 months or greater
* Age 18 years or older
* Creatinine \< 1.5 x ULN
* ANC \> 1500 ul
* Platelets \> 100,000 ul
* Total bilirubin, AST, and ALT \< 2 x ULN
* Amylase and lipase \< 1.5 x ULN
* C-kit mutation documented from either primary or metastatic tumor site
* \> 4 weeks from prior chemotherapy or investigational drug
* At least one measurable site of disease as defined by at least 1 cm in greatest dimension

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Pregnant or nursing mothers
* Any other significant medical, surgical, or psychiatric condition that my interfere with compliance
* Patient is \< 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
* Concurrent treatment with Warfarin
* Prior treatment with c-kit inhibitor
* Patient with Grade III/IV cardiac problems as defined by NYHA criteria
* No H2 blockers or proton pump inhibitors
* Known brain metastasis
* Known chronic liver disease
* Known diagnosis of HIV infection
* Previous radiotherapy to \> 25% of the bone marrow
* Major surgery within 2 weeks prior to study entry
* Patient has received any other investigational agent within 28 days of first study drug dosing
* Chemotherapy within 4 weeks prior to study entry
Clinical Outcomes and Equality in Healthcare for Emergency General Surgery Patients Undergoing Emergency Laparotomy

The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery.

The main questions it aims to answer are:

1. what factors are associated with adverse post-operative events
2. are patients treated differently based on sex or age
3. how does quality of life look like and possibly change over the coarse of a year after surgery

This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing emergency laparotomy due to general surgical indication

Exclusion Criteria:

* Children under 16
* Trauma laparotomy
* Vascular, urological or gynaecological indication for laparotomy
Follow-up Study of AAV-Mediated Gene Transfer (UX111; Previously Known as ABO-102) for MPS Type IIIA

The main objective of this study is to evaluate the safety/tolerability and efficacy of UX111 (previously known as ABO-102) in participants with Mucopolysaccharidosis IIIA (MPS IIIA).

This is a multicenter, long-term follow-up study of patients with MPS IIIA who have participated in a prior clinical trial involving the administration of UX111 (NCT02716246 and NCT04088734). No investigational product will be provided. At approved sites adjuvant immunomodulatory (IM) therapy may be administered to selected participants. The Principal Investigator and/or caregiver, in consultation with the medical monitor, will determine whether to initiate adjuvant IM therapy. Not all participants may receive IM therapy.

This study was previously posted by Abeona Therapeutics, Inc and was transferred to Ultragenyx in August 2022.

Eligibility Criteria:
Inclusion Criteria:

* Participants that have participated in a prior clinical trial in which they received UX111
* Parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule

Exclusion Criteria:

* Planned or current participation in another clinical trial that may confound the safety or efficacy evaluation of UX111 during this study
* Any other situation or medical condition that precludes the participant from undergoing procedures required in this study
Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

The purpose of this study is to examine weather treatment with anthocyanins will affect lipid profile, markers of inflammation and oxidative stress in addition to antioxidative level in serum to the better in persons with increased risk of dementia.

The purpose of this study is to examine weather treatment with anthocyanins will increase the score of relevant tests of cognitive function.

The investigators will do an open pilot study where patients receive anthocyanin for 16 weeks. 34 patients are expected to be included.

In addition we will include 20 healthy Controls.

Design, method and material:

The investigators will first do an open pilot study where 30 people will receive anthocyanins for 16 weeks.

The investigators aim to recruit persons with increased risk of cognitive reduction: persons over 50 years with stable coronary heart disease (CAD) from the cardiology department Stavanger University Hospital. In addition will persons with mild cognitive impairment or mild dementia be included from the memory outpatient clinic, Stavanger University Hospital.

Blood will be taken by venepuncture by an experienced nurse, centrifuged and handled in according to standardized procedures.

The patients will be tested in relevant tests of cognitive function at inclusion and after 16 weeks. At inclusion the patients will be tested in Mini Mental State Examination (MMSE) and Geriatric depression scale (GDS) to make sure that the patients meet the inclusion criteria. At inclusion and after 16 weeks the patients will be tested in Word List Memory Word List Recall Word List Recognition, Trail Making Test A + B and Stroop Word and Colour test.

From the healthy controls blood will be taken at inclusion and study end.

Eligibility Criteria:
Inclusion Criteria:

* Age above 50 years and coronary suspect chest pain with angiographically CAD without physiologically stenosis
* Mild cognitive impairment (ICD 10) or mild dementia, defined as fulfilling the dementia criteria (ICD 10) but with an MMSE score of 24 or higher.
* Stable medical treatment for the last 3 months.

Exclusion Criteria:

* Moderate to severe dementia (MMSE \< 24)
* Clinical significant depression (GDS-15 score of 7 or higher)
* Unstable coronary heart disease
* Heart failure in need of treatment
* Inflammatory illnesses such at rheumatoid arthritis etc.
* Another severe illness with \< 5 year expected survival time.
Surgical Treatment of Marfan Syndrome With Subluxation Lens

To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with MFS according to the revised Ghent etiology.
2. refractive errors difficult to correct.
3. pupillary block glaucoma caused by severe dislocation of the lens

Exclusion Criteria:

Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)
Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine

Observational, longitudinal, prospective, prospective, comparative study of the effectiveness of triptans before and after onabotulintoxin A initiation in a single group of chronic migraine patients.

Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.

Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.

Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.

All patients signed the informed consent and the study was approved by the Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.

Eligibility Criteria:
Inclusion Criteria:

* ICHD-3 criteria for chronic migraine (code 1.3). See Table 3.
* Older than 18 years and younger than 65 years.
* Migraine started in their lifetime before the age of 50 years.
* Migraine of more than one year of evolution since diagnosis.
* Normal cranial CT/MRI study.
* Indication for treatment with Botox
* Taking triptans as a rescue treatment for migraine attacks

Exclusion Criteria:

* Pregnant women
* Migraine of less than one year of evolution since diagnosis.
* Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
Ultrasound for Double Lumen Endotracheal Tube

The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube


Eligibility Criteria:
Inclusion Criteria:

* Surgery requiring placement of double-lumen endotracheal tube.
* ASA 1-3

Exclusion Criteria:

* History of difficult or impossible intubation.
* Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.
* Impossible placement of a double lumen tube