cyrilzakka/clinical-trials huggingface dataset:
Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section

Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.

Background: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.

Aim: This study is designed to compare the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.

Methods: This was a randomized equivalence controlled trial conducted among pregnant women booked for elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital Abakaliki, comparing the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective caesarean section at term. One arm received 100mg of suppository diclofenac and the other arm received 75mg of intramuscular diclofenac. These doses were repeated every 12hours for 24 hours. Pain scoring was done at 1, 6, 12, 18 and 24 hours after administration of the drugs. The data obtained was analysed using IBM SPSS software (version 23, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Elective caesarean section at term with spinal anaesthesia;E

Exclusion Criteria:

1. Allergy to NSAIDS
2. Bleeding diathesis
3. Use of general anesthesia
4. Chronic liver disease
5. History of renal disease
6. Asthma in pregnancy
7. Emergency Cesarean section
8. Morbid obesity
9. Sickle cell anaemia patients
10. Hypertensive disorders of pregnancy
11. Refusal to give consent
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071

This study will evaluate the safety and tolerability of ascending single oral doses greater than 500 mg of AEB071 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects from 18-55 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
* Female subjects had to either have been surgically sterilized or be postmenopausal.

Exclusion Criteria:

* Smokers
* Use of any prescription drug or over-the-counter medication within 2 weeks prior to dosing, or 2 months for inducers or inhibitors of cytochrome CYP4503A4 (paracetamol acceptable)
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
* History of History of fainting, hypotension when standing up, arrhythmia, acute or chronic bronchospastic disease
* History of clinically significant drug allergy; atopic allergy or a known hypersensitivity to any of the study drugs or drugs similar to the study drugs
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study
* History of immunocompromise (including a positive HIV test result) or drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse or a current positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Additional protocol-defined inclusion/exclusion criteria may apply
Infant Formula in Infants and Children With Cow's Milk Allergy

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.


Eligibility Criteria:
Inclusion Criteria:

* Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:

  1. Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \>0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
  2. Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/L if younger than 1 year;
  3. Documented cow's milk skin prick test wheal \>10mm;
  4. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
* Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges.
* Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
* Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
* Participant is between 3 months and 12 years of age at enrollment.
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* Participant is partially or exclusively breastfed at the time of enrollment.
* Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
* Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
* Previous severe anaphylactic reaction to cow's milk within the last two years.,
* An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
* Participant is consuming baked milk products.
* Use of and/or changing dose of high potency steroids.
Cognitive Aspects of Adolescent Suicide

The purpose of this project is to pilot a new scale, The Desperation Scale, in a sample of young adolescents (aged 10-16) seen in the pediatric emergency room who require a psychiatric consultation. The proposed study is designed to assess the psychometric properties of this new scale and to provide information about the cognitive state of young suicidal individuals. It is hypothesized that this scale will be able to discriminate between those who are suicidal and those who are not. Data obtained in this pilot study will provide information about the usefulness of the construct of desperation and will guide future projects aimed at the assessment and treatment of suicidal individuals. The use of cognitive factors to predict suicidal behavior is appealing because they allow the clinician to tap into an individual's perception of his/her life circumstances. However, we believe the popular conceptualization of suicide as a result of "hopeless" thinking ignores an important aspect of suicidal behavior-the motivation to escape. We propose that a model of suicidal behavior that includes escape motivation, which we call the desperation model, will be better able to predict suicide than existing measures. We conceptualize desperation as consisting of three core elements: a sense of entrapment, feelings of anxiety/agitation, and a sense of time urgency. The current pilot study will test a 35-item scale that assesses these three elements of desperation. A pilot study of the Desperation Scale is currently being conducted at the Cornell University Medical Center (P.I. P.M. Marzuk) with depressed, adult inpatients. Our study is original in its use of the scale with an adolescent population and its focus on patients in the emergency room, when they are presumably in a "purer" suicidal state. It is hypothesized that those who are admitted to the emergency room for recent suicidal behavior will endorse feelings of entrapment, anxiety, and time urgency.


Eligibility Criteria:
Inclusion Criteria:

* young adolescents seen in the pediatric emergency room at Yale-New Haven Hospital who require psychiatric consultation and who give consent to participate

Exclusion Criteria:

* diagnosis of a psychotic or organic brain disorder or inability to read the study questionnaire due to low IQ, learning disability, or non-English speaking status
Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.

Patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, T tube trials are used for weaning. The outcomes are compared in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients for more than 24 hours
* Satisfies weaning criteria
* RSBI \< 80
* Ratio of PaO2/FiO2 \> 250
* Arterial partial pressure of oxygen more than 60 mm Hg and carbon dioxide less than 50 mm Hg

Exclusion Criteria:

* Systolic blood pressure of less than 100
* Arterial partial pressure of oxygen less than 60 mm Hg
* Poor sensorium
Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

In this research, we will use established surveys to look at the relationship between various styles of coping with a disease, religious coping styles, treatment compliance, locus of control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs, recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR mutations, and co-morbid conditions such as diabetes, depression, and liver disease). While the research is correlational, it should suggest relationships (both positive and negative) between various coping styles and desired outcomes (compliance and well-being).

OVERVIEW: We anticipate that the data we collect will help us better understand some of the factors associated with improved coping, treatment compliance, and emotional adjustment, which, in turn, may suggest possible interventions to improve compliance, emotional adjustment, and general physical health. Specific hypotheses include the following:

1. Subjects who score high on measures of positive coping will have greater levels of treatment compliance and psychological well-being.
2. Subjects who score high on measures of negative coping will have lower levels of treatment compliance and psychological well-being.
3. Subjects who score high on measures of positive religious coping will have greater levels of treatment compliance and psychological well being.
4. Subjects who score high on measures of negative religious coping will have lower levels of treatment compliance and psychological well-being.
5. Subjects who score high on measures of internal locus of control will have higher levels of treatment compliance and psychological well-being compared to subjects who score low on measures of internal locus of control.
6. Subjects who score high on measures of treatment compliance will have higher levels of physical health.
7. We do not anticipate a positive correlation between positive coping mechanisms and general physical health; however, subjects who score high on measures of negative coping may have lower levels of general physical health (e.g., lower PFTs, increased rates and lengths of hospitalizations) probably due to third variables (e.g., if someone uses denial as a coping mechanism, it may lead to poor treatment compliance, which may lead to declines in physical health).
8. Anecdotal evidence suggests that parental education may be positively correlated with treatment compliance, but this has not been evaluated. Likewise, anecdotal evidence suggest that marital status may be correlated with treatment compliance (probably because of third variables, e.g., if, as much research suggests, divorce is related to lower SES and fewer social supports, these factors may in turn interfere with treatment compliance). Two questions on the demographic sheet will allow us to explore whether or not this may be worth exploring further.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis age 13-19 yrs

Exclusion Criteria:

* acutely ill
Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.

The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations

In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study

Exclusion Criteria:

* patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain

This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.

This prospective observational study aims to determine the limit of TcPO2 predictive of postoperative cutaneous pain in patients with ankle trauma.

A TcPO2 measurement will be performed preoperatively at the patient's arrival in the emergency room, then every day after the operation for 3 days and finally at the follow-up visits at 3 and 6 weeks.

The cutaneous pain is evaluated by a PSAS self-questionnaire (completed by the patient) and an OSAS questionnaire (completed by the surgeon). These grids evaluate the tolerance and cicatricial quality in the medium and long term by the operator and the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgery of ankle trauma

Exclusion Criteria:

* Patient who does not agree to participate
* Patient unable to express agreement (ex: unconscious)
* Minor patient
* Major patient under tutorship or curatorship
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan

N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male and female patients \> or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
* Measurable disease
* Disease site(s) must be distal to the planned site of tourniquet placement
* Available for immunohistochemical testing of N-cadherin expression tumor tissue
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG

Exclusion Criteria:

* Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
* Stage IV melanoma
* Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
* History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
* Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
* Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities
* Allergic reaction to any therapeutic peptide or to melphalan
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness. The intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps. The app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps.

The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. Throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. Following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Speaks Twi or English
* Current inpatient staying at a study prayer camp
* A diagnosis of psychosis, mania, or depression

Exclusion Criteria:

* Serious physical illness or in need of urgent medical attention
Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions

The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.

This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
3. Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
6. Subject has read and signed a written informed consent form.
7. Subject is willing to comply with adjuvant topical regimen, as applicable.
8. Subject agrees not to undergo any other procedure(s) in the treatment area during the study.

Exclusion Criteria:

1. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject
2. Use of Accutane within the previous 6 months
3. History of melanoma
4. Subject is pregnant or intending to become pregnant during the study period
5. Subject is lactating or has been lactating in the past 6 months
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with the study requirements.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)

This crossover study is designed to compare the rates of gastric emptying between two diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott Vital®. Healthy participants will be recruited and randomly assigned into either groups of Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be calculated using established algorithms.

The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare because the food needs to be cooked first and it will take time to prepare. Besides, the egg-white sandwich is not suitable for those with allergies to egg and bread and also to vegetarian patients. This gold-standard meal is also not a common meal for Asian people so some of the people may not tolerate with the meal. The aim of this study is to determine whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the gastric meal retention of both meals.

Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index (BMI)
* Able to give consent
* 18 years old above

Exclusion Criteria:

* Vegetarian
* Allergy or cannot tolerate with milk, egg, and bread
* Participants with past and current history of chronic medical illness
* Currently on medication that can affect gastrointestinal function are also excluded