cyrilzakka/clinical-trials huggingface dataset:
The Effects of Cold Adaptation on Skin Blood Flow, Hand Function, and Comfort in Healthy Adults

In cold weather environments, blood flow to the extremities is significantly reduced, which severely impairs hand function and induces thermal discomfort. Prolonged or repeated cold exposure elicits an adaptive habituation response that is characterized by blunted skin vasoconstriction and thus may be an effective strategy to improve peripheral perfusion, reduce thermal discomfort, and maintain hand function during cold weather military operations. Since mission conditions often involve low ambient temperatures, countermeasures that reduce cold-induced decrements in hand function and thermal comfort are important to enhance Warfighter readiness in cold weather battlefield environments. The goals of this study are to 1) evaluate the effectiveness of cold habituation in improving skin blood flow, hand function, and thermal comfort during cold exposure and 2) identify the mechanisms that contribute to improvements in skin blood flow following habituation.

Participants (n=15, 18-39 yrs) will complete a preliminary cold air exposure (baseline testing) followed by 8 days of repeated cold air exposures with minimal clothing. The cold exposures will be 2 hours in duration and will be conducted in 8°C (46°F) conditions. Before and after the repeated cold exposures, participants will undergo hand function tests, assessments of thermal comfort, and skin blood flow testing.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-39
* In good health as determined by OMSO (Office of Medical Support and Oversight)
* Willing to refrain from exercise and caffeinated or alcoholic beverages for 12 hours before each testing session
* Willing to refrain from smoking or tobacco use 8 hours before each testing session

Exclusion Criteria:

* History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains).
* Raynaud's syndrome.
* Cold-induced asthma/bronchospasm
* Previous hand/finger injuries that impair dexterity and hand function.
* Metal hardware (plates/screws) in the forearms and hands.
* Current use of medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control (e.g., anti-hypertensives, statins).
* Known allergies to medical adhesives.
* Heart, lung, kidney, muscle, or nerve disorder(s)
* A planned MRI during the study or within 2 days after completing a cold test.
* Women who are pregnant, planning to become pregnant, or breastfeeding.
* Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)
PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography

The contrast induced kidney toxicity has been known to affect the mortality and morbidity in the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive effects for contrast induced kidney toxicity with its antioxidant effects.The statins have been reported to have many other effects other than the lipid lowering effect-including antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent the contrast induced kidney toxicity.

The simvastatin may prevent the contrast agent induced acute renal failure in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of simvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Angina patients
* Patients who is required the coronary catheterization
* creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula Patients who undergo coronary catheterization
* Age of 19 or over 19

Exclusion Criteria:

* pregnancy
* lactation
* having received contrast media within 7 days of study entry
* emergent coronary angiography
* acute renal failure
* end-stage renal disease requiring dialysis
* history of hypersensitivity reaction to contrast media
* cardiogenic shock
* pulmonary edema
* multiple myeloma
* mechanical ventilation
* parenteral use of diuretics
* use of N-acetylcysteine
* use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery

Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.

However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Esophageal and esophago-gastric junction cancer is the seventh most common malignancy and the sixth leading cause of cancer-related mortality worldwide.

Surgery remains the primary treatment for esophageal cancer and is one of the most technically challenging interventions in oncological surgery. In addition, esophagectomy is associated with high risks of postoperative complications, with rates varying from clinic to clinic. Esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively.

The problem with the available studies of the course of the postoperative period is the significant heterogeneity of research methods, which does not allow us to obtain a true picture of the results of surgical treatment of the esophagus and esophagogastric junction cancer in the Russian Federation.

To improve the quality of further studies and recommendations on standardization of surgical treatment of esophageal and esophagogastric junction cancer and its morbidity, there is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024

Exclusion Criteria:

* Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers.
* Esophagogastric Junction Siewert III malignancy
* Patients submitted to Emergency surgery or surgery without curative intent
* Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy
The Effect of Alginate Supplementation on Weight Management

This project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period.

To achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. Volunteers will be randomly allocated into active or placebo arm of the trial, both will receive capsules with the same appearance.

The volunteers will have their height, weight, waist circumference, body composition, and fasting levels of circulating glucose, triacylglycerol and cholesterol measured at each for the four visits.

The study will last approximately 12 weeks depending on your availability.

Volunteers will be asked to come to the research facility in Newcastle University, before they have had any breakfast, on four separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea or coffee.

Each time the volunteers come in, their height (first assessment only), weight, waist circumference and body composition will be measured. Body composition is measured using scales which can determine the percentage of their body is fat or bone or muscle. This is done using a small harmless electrical current passing through their body, they will not detect or feel this at all. Their height will also be measured at the first visit. Cholesterol, triglyceride and glucose levels in the blood will also be measured at each visit. This will be done through a single finger prick blood sample.

Enough capsules will be given to the volunteers to last you four weeks at the first three visits. The capsules will be filled with either alginate or another dietary fibre believed to have no effect on weight management.

Volunteers will be asked to take four of these capsules with their three main meals per day over the 12 week study.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* BMI over 20

Exclusion Criteria:

* Pregnant, lactating,
* BMI under 20
A Study Of PF-06647263 In Patients With Advanced Solid Tumors

To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
* Performance Status of 0 or 1
* Adequate bone marrow, kidney, and liver function
* Part 2 includes advanced triple negative breast cancer patients.

Exclusion Criteria:

* Brain metastases requiring steroids
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
* Active and clinically significant bacterial, fungal or viral infection
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE

This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.

trial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
* Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
* AF first detected ≤1 year prior to randomization
* Informed consent

Exclusion Criteria:

* End-stage cancer or life-expectancy \< 12 months due to other advanced co-morbid illness
* Prior AF ablation or surgical therapy of AF
* Patients not suitable for rhythm control of AF due to cardiac conditions
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women

Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate.

Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in Sweden. The investigators chose an initial study period in late spring to reflect the effects of the dark season with little ultraviolet B radiation that affects vitamin D production. Study 1 was carried out in a short period of time. The recruitment was performed in a retrospective design in order to neglect the seasonal effects of ultraviolet B radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71).

Study 2: Examines the results on muscular performance, i.e. grip strength and squatting ability, from intervention with advice and prescription of vitamin D3 and calcium for 10 months, in all the women from study 1 with 25-OHD levels \<50 nmol/L or 50 nmol/L of 25-OHD.

Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery outcome in birth protocols starting 2016.

Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and strength in the group of Somali women by focus interviews among the Somali women from above.

A possible fifth study will explore correlations between 25-OHD and pain distribution and pain parameters.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant or new mother from Sweden or Somalia living in Borlänge and registered the antenatal clinic in Borlänge maximally 21 months prior to study start.

Exclusion Criteria:

* Severe metabolic, medical or mental disease (ex. deranged type I diabetes or psychosis).
New Vital Pulpotomy Medications in Primary Molars

Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.

Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:

1. Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.
2. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Eligibility Criteria:
Inclusion Criteria:

* -Clinical criteria

  1. Restorable mandibular primary molars with deep carious lesions.
  2. Absence of gingival swelling or sinus tract.
  3. Absence of spontaneous pain
  4. Absence of pain on percussion. B-Radiographic Criteria: Absence of

  <!-- -->

  1. Discontinuity of lamina dura
  2. Internal root resorption.
  3. External root resorption.
  4. inter-radicular or periapical bone destruction (radiolucency)

Exclusion Criteria:

1. Excessive bleeding during pulp amputation.
2. Non vital/necrotic teeth.
3. Any sort of medical history contraindicating the pulp treatment.
4. Teeth approximate exfoliation
5. Patient's guardians are not intending to be part of the study.
6. Retreatment of previously pulpotomy treated molar -
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation

Exclusion Criteria:

* Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections
Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.

A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Duration of pregnancy \< 12 weeks.
* Age ≥18 years

Exclusion Criteria:

* Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC

The patients with anaplastic thyroid cancer were treated with CAR-NK immune cells combined with PD-1 monoclonal antibody, and the safety and tolerability of the patients were observed and evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years (including boundary values), male or female.
2. Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm.
3. Liver and kidney function is good, and can tolerate treatment.
4. Be able to cooperate with the completion of treatment and follow-up work.
5. No other systemic diseases, including other malignancies.

Exclusion Criteria:

1. Need to breastfeed the baby or have fertility needs；
2. Immune system diseases;
3. Diseases of the blood system;
4. Mental system diseases;
5. Interstitial pneumonia, lung disease, etc.;
6. Failure to follow rules of this study.
Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity

Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age \> 55 years
* body mass index \> 25 kg/m2

Exclusion Criteria:

* no history of H2 supplementation within the 4 weeks before study commenced
* no major chronic diseases, as evaluated by pre-participation health screening and clinical chemistry
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.

The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study.

Presbyopic subjects aged 45 to 55 years were the primary age group in this study.

Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.

Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3.

The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment.

There were two secondary endpoints:

1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to 55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75 or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or Placebo treatment.
2. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in all subjects after UNR844-Cl or Placebo treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Impaired near vision in each eye and when using both eyes, without any near correction
* Need a certain level of near correction

Exclusion Criteria:

* Impaired distance vision in either eye, with distance correction (if any)
* Severe short- or long-sightedness
* Any significant medical or clinical conditions affecting vision, the eyes or general health
Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds

Singapore has one of the world's highest diabetes-related lower limb amputation rates in the world. Between 2008 - 2017, 4724/5306 (89.0%) of all major amputations and 6656/7227 (92.1%) of all toe/ray amputations performed in Singapore were for diabetic patients. Diabetic foot ulcers are generally slow to heal and poor wound management may lead to infection and subsequently major amputations. Hence, adequate wound care to achieve wound healing efficiently and effectively is of utmost importance.

In the investigators' clinical practice, Negative Pressure Wound Therapy has been the dressing of choice to aid wound closure and prevent infective complications. Drainage of wound exudates helps to reduce and prevent infection, promote granulation tissue proliferation and induce cell growth. When used in combination with dermal substitutes, graft uptake is improved by further promoting proliferation and encouraging tissue regeneration.

Wounds can also be closed surgically though primary closure, where the skin is closed and serves as a physical barrier against infection. The technique is not without its pros and cons. Primary closure may decrease healing time and reduce need for additional surgery, but these patients are also at risk of recurrent infection and may require more proximal amputation. These may be circumvented with delayed primary closure, which is the surgical closure of the amputation wound at a delayed timing after amputation. This gives the clinical team time to optimize the wound and ensure that there is no underlying infection prior to closure.

The experience of NPWT + Kerecis Omega 3 and delayed primary closure have been positive. To the investigators' current knowledge, there is only one case series reported for the use of fish skin graft in combination with NPWT for the treatment of acute pediatric wounds and two case series for the use of NPWT in diabetic foot wound that has undergone surgical closure. The proposed study would be the first RCT to evaluate effects of combination therapy in both open and closed diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-100
* First or last toe ray amputation
* Adequate perfusion (either \>50% stenosis on duplex ultrasound or undergone successful revascularization with \<30% residual stenosis)

Exclusion Criteria:

* Amputations not at first or last toe
* Venous ulcers
* Heel ulcers
* Osteomyelitis
* Active Infection
* Patients on imunosuppressant
* Patients with known allergy to fish
* Patients unable to give informed consent.