cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Oral PCA Device - PCoA™ Acute

Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.


Eligibility Criteria:
Inclusion Criteria:

1. Operative procedure with at least 3 days' hospital stay.
2. Planned post-operative pain therapy with oral medication using a strong opioid.
3. No contra-indication for opioid therapy.
4. No contra-indication for oral pain therapy.
5. Patient was able to understand and complete the questionnaire.
6. Patient signed an informed consent form.

Exclusion Criteria:

1. Opioid or drug addiction. 2. Opioid intolerance. 3. Pain therapy using IV PCA or infusion. 4. Rejection of opioid therapy. 5. Not able to swallow medicine.

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Effect of Diaphragmatic Release on Upper Crossed Syndrome

the study aims to investigate the effectiveness of diaphragmatic release on upper crossed syndrome

Poor posture typically causes upper cross syndrome, resulting in neck pain. Neck pain is the most common reason for patients to visit healthcare professionals. This syndrome can cause dysfunctional tone in posture and muscular disparity of the head, neck, and shoulder region . Evidence suggests that 6-48% of the upper crossed syndrome population complain of pain in the shoulder girdle and cervicothoracic region.

Many disorders are linked with the upper crossed syndrome, including migraine headaches; chronic headaches; Subacromial impingement; biceps tendinitis; thoracic outlet syndrome; degeneration of the cervical spine; and joint dysfunction at the C1-C2 segment, C4-C5 segment, cervicothoracic joint, and T4-T5 segment.

Upon the available research studies, there is no study conducted to investigate the effect of diaphragmatic release on upper crossed syndrome patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 17 to 22 years .
* Body Mass Index from 20 to 25 kg/m².
* All participants have an intensity of neck pain on VAS (4-8) (moderate cases).
* The subjects were chosen from both sexes.
* All participants have kyphosis angle ≥42°
* All participants have mechanical neck pain and FHP (craniovertebral angle CVA \< 49).

Exclusion Criteria:

* Malignancy
* Fractures of the cervical spine
* Cervical radiculopathy or myelopathy
* Vascular syndromes such as vertebrobasilar insufficiency
* Rheumatoid arthritis
* Neck or upper back surgery
* Taking anticoagulants
* Local infection
* Whiplash injury
A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to provide voluntary written informed consent
2. Male and female patients ≥18 yrs and ≤75 yrs
3. Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months
4. A baseline 24-hour average daily pain intensity score ≥5
5. Women must be of non child-bearing potential, defined as post menopausal or surgically sterile

Exclusion Criteria:

1. Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
2. Other causes of neuropathy or lower extremity pain
3. Complex regional pain syndrome or trigeminal neuralgia
4. Lower extremity amputations other than toes
5. Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study
6. Major depression.
7. Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
8. Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigator's medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patient's safety or study outcome
Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.

To perform a prospective randomized controlled trial to determine the hemostatic effect of TXA soaked gauze (intervention) versus normal saline soaked gauze (control) when applied to granulating defects in the setting of Mohs micrographic surgery.

Patients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their Mohs micrographic surgery (MMS).

One arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of MMS.

A second arm will receive TXA 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of MMS.

In both arms, the telfa pads will have a standard pressure dressing placed overtop.

Eligibility Criteria:
Inclusion Criteria:

* All adult (18 years or older) patients presenting for Mohs micrographic surgery (MMS) for the treatment of melanoma or nonmelanoma skin cancer (NMSC) with a wound that will be healing by granulation

Exclusion Criteria:

* Patients must not be pregnant or breastfeeding.
* Patients must not have a known allergic reaction or sensitivity to TXA
* Patient must not have an international normalized ratio (INR) out of therapeutic range if on warfarin.
Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)

Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.

The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.

The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.

The investigators plan to recruit 20 patients.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)

  * Gestational age (GA) \< 34 weeks
  * Corrected age \< 34 weeks
  * Receiving nasal CPAP for respiratory distress
  * Respiratory "stable": FiO2 \< 30%, pCO2 \< 8,5 kPa and pH \> 7.25.
* GA \< 29 weeks: Respiratory "stable" over last 72 h.
* GA 29-33 weeks: Respiratory "stable" over last 24 h.

Exclusion Criteria:

1. Congenital anomalies
2. Ongoing treatment for hypoglycemia or infection
3. Other intercurrent disease requiring frequent blood sampling
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\^2), inclusive, and body weight ≥50.0 kg.

Exclusion Criteria:

* History of rhabdomyolysis.
* History of peptic ulcer disease or significant GI bleeding.
* History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
The Effects of Glycemic Optimization Before Gastric Bypass Surgery

Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether:

* metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission.
* metabolic surgery is safe for microvascular complications of Type 2 diabetes
* good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes.

This study aims to assess:

1. whether metabolic surgery is better for diabetes control compared to medical treatment.
2. whether metabolic surgery is safe for eye, nerve and kidney complications.
3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group).

Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.

Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia.

Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with T2DM and BMI above 35kg/m2
2. HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.

Exclusion Criteria:

* End stage retinopathy, nephropathy or neuropathy.
Tranexamic Acid for Anaemia Trial

Anaemia is a common health problem in women. It is often due to iron deficiency. Anaemia is a particular problem during pregnancy and is bad for the mother and baby. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Heavy menstrual periods are a common cause of iron deficiency and even if women do take iron, because they lose so much iron in their periods, they still become iron deficient. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)

World-wide, half a billion women of reproductive age are anaemic. Anaemia has major health consequences for pregnant women and their babies. Anaemia increases the risk of ante-partum haemorrhage, prematurity, stillbirth, neonatal death, post-partum haemorrhage and maternal death. Early intervention to reduce the risk of anaemia before pregnancy offers the potential to reduce adverse maternal and birth outcomes and improve well-being across the reproductive life course.

Unfortunately, global efforts to reduce anaemia prevalence by 2025 are far off track. Anaemia worsens bleeding through multiple biological mechanisms. Anaemia increases blood flow from bleeding vessels due to reduced blood viscosity and anaemic blood clots are more susceptible to fibrinolysis. Although iron and multivitamin replacement is the mainstay of anaemia treatment, iron stores in young women depend more on menstrual iron loss than on dietary intake. Because anaemia worsens bleeding, women with anaemia have heavier menstrual periods than if they were not anaemic. For this reason, offering iron replacement without reducing menstrual iron loss may be inefficient.

The antifibrinolytic tranexamic acid (TXA) reduces menstrual bleeding by preventing blood clot breakdown. The investigators propose that giving TXA with iron and vitamin replacement will be more effective in treating anaemia than iron and vitamin replacement alone.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (aged 18 years and older)
* Having menstrual periods every 21 to 38 days that last 2 to 9 days
* Having anaemia (Hb \< 120 g/L) according to point-of-care finger prick screening test
* Willing to provide informed consent and able to attend study visits during the trial period

(Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)

Exclusion Criteria:

* Planning to get pregnant during trial period
* Already taking TXA
* Known to have contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)
Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion

Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion

Currently, patients undergoing contraceptive implant insertion are offered local anaesthetic with an injection before insertion. This study aims to look at whether patients find using the local anaesthetic spray more acceptable or equally acceptable to using local anaesthetic injection. Both are currently licensed products for use as skin anaesthesia but the spray is potentially quicker and involves less injections. Some areas of sexual health are already offering this option but there isn't much evidence as to which patients find more acceptable.

Patients in this study will be given a choice of anaesthetic asked to complete a short questionnaire, giving a pain score , on the pain rating scale of 0 to 10, ( being no pain to 10 being extremely painful. ) In addition, they will be asked to give the reasons for their choice. The questionnaire will be anonymous.

Average pain scores will be calculated between in group and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patient has chosen to use the implant as a method of contraception
* Patients will be assessed for medical eligibility for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other.
* Age between 13 and 55
* Has capacity to consent
* Has read the information sheet and consents to the study
* This will be offered for insertions of implant only i.e. not implant removals

Exclusion Criteria:

* Has a contraindication to have a contraceptive implant
* Doesn't wish to have a implant
* Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other
* Is under 13 or over 55
Study of ZIO-201 in Advanced Sarcoma

The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.


Eligibility Criteria:
Metastatic and /or unresectable disease state after previous standard chemotherapy
Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents

The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 16-17 years old
* Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
* Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
* Available and committed to engage with the program and complete assessments for an 8-week duration
* Able to read and write in English
* U.S. resident
* Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
* If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
* Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions

Exclusion Criteria:

* Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
* Lifetime diagnosis of bipolar disorder
* Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
* Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
* History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
* Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
* Previous Woebot Application use
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.


Eligibility Criteria:
Inclusion Criteria:

* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
* Is a current full time soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in a concurrent clinical trial.
* Has a latex sensitivity.
'' Abdominal Crunch Positions With the Others in Terms of Interspinous Distance in Adult Patients ''

The most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion.

In a study by Martha L Walker et al., The maximum extension of the knees, adduction of the hip, and a modified sitting position with the back flexion, ie, the abdominal crunch position, were found to be effective in increasing the flexion of the lumbar spine.

In our study, we aimed to measure the interspinal distance with the abdominal crunch position with the help of ultrasonography (USG) and to compare the interspinal distance with the measurements obtained in traditional positions (sitting position and lateral decubitus).

Interspinal distance will be measured by ultrasonography by 3 different positions, respectively, for the patients who will undergo elective surgery and meet the study criteria and give voluntary consent.

This evaluation process is to record and compare the measurement results. Patients will not undergo any interventional procedures.

Patients who have difficulty in positioning due to hip, femur, knee and tibial fractures or arthrosis and who cannot be communicated will not be included in the study.

One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Undergo elective surgery

Exclusion Criteria:

* Patients with vertebral anomaly
* Patient with not communicated
The Future Management of Patients With Neoplasms of the Gastro-intestinal Tract

The aim of the present study is to research histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

The aim of the present study is to search for histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* PS ECOG 0-2;
* Histological diagnosis of cancer of the gastro-enteric district: intestinal, pancreatic, biliary tract neoplasms;
* Radiological evidence of resectable/locally advanced/metastatic disease on the date of the first visit;
* Availability of tumour histological material;
* At least one visit following the first oncological visit.

Exclusion Criteria:

* Absence of histological diagnosis of neoplasm of the gastro-enteric tract;
* Lack of histological specimens on which to perform examinations.
Evaluation of the Composition of Human Milk and Health Outcomes in Children

This study is an evaluation of the composition of human milk and health outcomes in children.


Eligibility Criteria:
Inclusion Criteria:

* Human milk samples from mothers from a larger birth co-hort study
* Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age
Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.


Eligibility Criteria:
Inclusion criteria:

- healthy male and female subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions