cyrilzakka/clinical-trials huggingface dataset:
Endorphin Massage Application to Women Who Gave Birth Vaginally

In this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.

Massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. In addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. It is also known as the happiness hormone.

It is stated that back massage will increase the release of endorphin hormones by relaxing the mother. In other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort.

Studies have shown that endorphin massage applied to pregnant women reduces back pain. In another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. In the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety.

When the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. The fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. It is aimed to determine the effect on endorphin level.

Eligibility Criteria:
Inclusion Criteria:

* 37-40. Those who gave birth vaginally in their gestational week,
* In the first 24 hours postpartum,
* Primiparous,
* Episiotomy applied,
* Having a VAS value of at least 5 points,
* Having given birth to a single baby,
* Your baby's APGAR Score is between 7-10,
* Skin-tissue integrity,
* No communication problem,
* The spoken language is Turkish,
* Voluntary to participate in the study

Exclusion Criteria:

* The baby was admitted to the neonatal intensive care unit,
* Having a cesarean section,
* Experiencing risky labor,
* Postpartum bleeding,
* Epidural analgesia applied
* Having a psychiatric disease (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
* Having chronic disease (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD),
* Postpartum women diagnosed with risky pregnancy (Pre-eclampsia, Eclampsi, Pregnancy-related hypertension, Gestational diabetes, bleeding conditions during pregnancy)
fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study

Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery


Eligibility Criteria:
Inclusion Criteria:

* OA Group

Unilateral Knee OA No previous knee surgery Able to give informed consent Age \> 40 years

- Healthy Volunteers Group

No OA or knee pain Able to give informed consent Age \> 40 years

Exclusion Criteria:

-OA Group

Major medical, psychiatric, neurological Cx Other chronic pain condition (fibromyalgia) Contraindications to MRI Active Cancer Neuropathic drug treatment

-Healthy Volunteers Group

Pregnancy Lower limb pain or previous knee surgery Contraindications to MRI Active Cancer Major medical, psychiatric, neurological condition
Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes
* Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study
* Be willing to provide written informed consent
* Be willing and able to follow instructions
* A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential)

Exclusion Criteria:

* Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye
* Prior or anticipated concurrent use of an investigational drug or device
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation
Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa

Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa


Eligibility Criteria:
Inclusion Criteria:

* children under 18 years epidermolysis wounds requiring dressing changes
Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer

Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.

In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged between 20 and 50 years.
* Signed voluntary written informed consent.
* Body mass index between 16.0 and 30.0 kg/m2.

Exclusion Criteria:

* History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
* History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
* History of any kind of medication(s) within 1 week before screening.
* Presence of clinically significant electrocardiogram abnormality at screening.
* aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
* Serum creatinine levels : greater than 1.5 × upper normal limit.
* Platelet counts lower than 100,000 / μL
* Serum potassium : greater than 5.5 mmol/L
* Female who is pregnant, breastfeeding, or intends to become pregnant.
* History of noncompliance with medications.
* History of alcohol abuse.
* Participation in drug study within 30 days before screening.
* Galactose intolerance
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise

The study aims to examine the effect of a New Zealand blackcurrant (NZBC) supplement on markers of muscle damage and recovery following strenuous resistance exercise. The investigation will compare responses between an experimental (NZBC capsule, 300 mg/day) and placebo (PLA capsule, 300 mg sugar) group. Participants will attend a screening session where they will consent to the study, complete a pre-activity medical questionnaire and have their height, weight and resting blood pressure measured. If the participants meet the inclusion criteria they will perform a familarisation session on the muscle strength assessment. Participants will be randomized to NZBC or placebo groups, and consume one capsule in the morning (between 6-10 am) for 12 days. This is a double-blinded study, which means that the participant and the study team will not know which group the participants are assigned to until the study is over. On day 8 participants will perform a strenuous bout of upper body resistance exercise on the isokinetic dynamometer (exercise device). Muscle strength and soreness, arm circumference, and elbow range of motion will be measured, and a fasted blood sample will be collected, before and 24, 48, 72 \& 96 hours after the muscle fatigue protocol (on days 9, 10, 11 \& 12). A marker of muscle damage (creatine kinase \[CK\] concentration) will be measured in the blood samples. Participants will also be asked to complete a 6-day dietary record, beginning on day 7 and ending on the final day of testing (day 12).


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 18 - 45 years old
* BMI: 19 - 29.9 kg/m2
* Healthy: no active disease process that could interfere with endpoints measured as determined by medical history

Exclusion Criteria:

* Smoking and tobacco use
* Takes medication \[excluding contraception\]
* BMI ≥ 30 kg/m2
* Hypertensive (diastolic \> 90 and/or systolic blood pressure \> 140 mmHg)
* History of musculoskeletal upper limb injuries
* Performs regular resistance exercise (\> 2 sessions per week)
* Uses dietary supplements that could influence muscle recovery or function (e.g. protein supplements, antioxidants etc)
Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients

The patients in the experimental group received the relevant knowledge education in the recovery period 30 minutes before anesthesia. The operation time, anesthesia time, cooperation degree score, total cooperation rate and patient satisfaction were observed and recorded. Results: there was no significant difference in operation time and anesthesia time between the experimental group and the control group (P \< 0.05). The percentage of patients in the experimental group was 20.12% and 70.89% respectively, while that in the control group was 40.32% and 20.73% respectively (P \< 0.05). The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group. There was significant difference between the two groups (P \< 0.05). The satisfaction of patients in the experimental group was 95%. 65% of the patients in the control group were satisfied (P \< 0.05). Conclusion: preoperative psychological intervention for patients with general anesthesia and endotracheal intubation can significantly reduce the restlessness and uncooperative phenomenon during extubation, and improve the cooperation rate and satisfaction of patients.


Eligibility Criteria:
Inclusion Criteria:

the patients who will undergo cholecystectomy surgery

Exclusion Criteria:

the patients who can not well communicate
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer

This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed SCLC with known UGT1A genotype.
* Patients who have received at least 1 prior platinum-based chemotherapy.
* Life expectancy of 3 months or more.
* Measurable disease.

Exclusion Criteria:

* Patients with UGT1A polymorphism.
* Currently receiving chemotherapy.
* Pregnant and nursing women.
Patient Preferences in Anesthesia for Abortion Care

This study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. We will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.

This study will utilize an open-ended semi-structured interview format to elicit a broader understanding of the multi-dimensional pain experience of woman undergoing an abortion procedure. This study seeks to provide further evaluation of the pain experience and preferences of women receiving alternative methods of pain management such as oral sedation and nitrous oxide.

The study will use semi-structured interviews to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion and will include a procedural pain outcome using the visual analog scale (VAS) to create a more patient centered experience.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing first trimester surgical abortion choosing between oral anesthesia or nitrous oxide for pain management
* women who are able to read and understand English
* women who are 18 years old or older

Exclusion Criteria:

* under the age of 18
* women unable to consent and/or are cognitively impaired
* women who are incarcerated
* women who do not speak English
Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

the aim is to measure the level of adherence of knee osteoartheritis patients to a Carefully curated program that follows the American College of Rheumatology/Arthritis (ACR) recommendation guidelines and investigate the factor that might affect the patient's adherence to the prescribed protocol.

2.3. interventional protocol (for intervention group only): For the Intervention group: A face-to-face semi-structured interview was carried out with each participant separately. The interview (30-45minuts) included a health education program explaining the nature of the condition(KOA causes, pathological changes, and natural course of the disease), we explained the recommendations for the treatment of KOA, teaching the patient a home exercise program of 5 exercises (targeting knee extensor and hip muscle ), selection of a physiotherapy program suitable to the patient clinical condition, recommendations to increase daily physical activity ( e.g. brisk walking) with joint protection measures along with a weight reduction regimen proposed in overweight and obese patients and prescribing a suitable pharmacological treatment to the patients mentioning side effect that might occur. At the end of the interview, each participant received a booklet including the recommendations for the treatment of knee osteoarthritis according to the ACR.

As for the control group, they were assigned the traditional approach for KOA management, they were told their diagnosis if they were not already familiar with it, received the treatment for KOA according to ACR guidelines, they were offered physical therapy modalities if their condition required but they were not given the health education program or the other interventional steps.

2.4. Follow-up period: Throughout the following three months after enrollment, participants were followed up every ten days; asking about persistence on the prescribed treatment and exercise program, the level of their daily activity, and their diet plan. For participants who failed to attend for any reason, a telephone call was performed to provide behavior change support in both groups. The telephone call aimed to observe adherence to treatment in the control group and to increase levels of participation in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria

Exclusion Criteria:

* Patients with a

  1. A history of knee trauma or injury
  2. patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis)
  3. severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.
Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help their pain, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses less pain as a primary desire
* Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* The calculated validated health survey (PRO) score during enrollment represents less than mild severity
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in a clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAOIs (monoamine oxidase inhibitors)
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).


Eligibility Criteria:
Inclusion Criteria:

* Has a BMI between 18.0 and 40.0 kg/m2, inclusive
* Has a diagnosis of schizophrenia
* Has a diagnosis of alcohol use disorder (AUD)
* Has experienced an acute exacerbation of schizophrenia within the past 6 months
* Additional criteria may apply

Exclusion Criteria:

* Is pregnant or breastfeeding
* Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
* Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
* Has current or pending legal charges with the potential for incarceration
* Has a positive drug screen for opiates
* Additional criteria may apply