cyrilzakka/clinical-trials huggingface dataset:
Learning to Resolve Family Conflict

This study will evaluate the effectiveness of conflict resolution training for families with preschool and elementary school-aged children.

This study will examine the language, reasoning, and social skills used by preschool and elementary school children when they and their parents attempt to understand, conduct, and resolve disputes in everyday family interaction. Families will be given conflict resolution training designed to promote listening and speaking skills that result in more accurate interpersonal and emotional understanding. The training may lower the emotional volatility of family interaction, lower the rate of arguing and fighting between parents and children, increase the rate and frequency of verbal negotiation, and encourage the adoption of conflict strategies that focus on future-oriented behavior and positive outcomes.

A total of 324 working class families, representative of the primary ethnic populations in Chicago (African American, Caucasian, and Mexican American), will be selected for participation. Both parents, one 4- to 6-year-old child, and one 6- to 8-year-old sibling will participate. Single parent families will also be included; the parent will be asked to nominate a second adult or an additional older sibling in place of the second parent.

Each family proceeds through three phases. The initial phase allows assessment of conflict histories, good times, self-appraisals of psychological well-being, affective and social variables that operate within the family, and the family members' ability to discuss and negotiate ongoing problems.

In the second phase, families are randomly assigned to one of three experimental conditions. One group is given conflict resolution training and then participates in a series of tasks that focus on child-parent narration, negotiation, and negotiation assessments. A second group participates in the same tasks without training. A third group undergoes only the negotiation assessments. The effectiveness of the training will be evaluated by experimentally assessing conflict resolution skills before and after training in both home and school contexts.

The third phase is a six-month follow-up visit, during which parents and children are again observed negotiating problems. Psychological well-being and affective feelings are once again assessed. The study ends with a debriefing interview for the parents.

The study consists of 14 study visits. Each member in the family will also have four training sessions. Visits are scheduled 3 to 4 times a month, depending on the family's availability.

Eligibility Criteria:
Inclusion Criteria:

* Nuclear family with at least one biological parent
* African American, Caucasian, or Mexican American
* At least two children: one between the ages of 4 and 6 years, and one between the ages of 6 and 10 years
Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents

An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who are being treated at a participating OPAL clinic.

Exclusion Criteria:

-
Novel Breath Test to Detect Early Stage Chronic Pancreatitis

The goal of this study is to evaluate the feasibility of using a non-invasive, non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of chronic pancreatitis (CP). If successful, this method could have important advantages over existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have a clinical impact if it leads to early detection of CP and intervention to mitigate disease progression.

Disorders of the pancreas affect more than one million persons in this country with nearly $3 billion in health care costs. The incidence rate of chronic pancreatitis (CP) is rapidly increasing and may be related to expanded alcohol abuse. Advanced CP can be easily detected by imaging techniques. However, mild to moderate CP presents a more difficult challenge for clinicians. Imaging techniques fail to recognize less advanced CP cases about 40% of the time. The gold standard for monitoring early stage CP is the secretin stimulation test. However, the secretin stimulation test is only done in a few US centers.

The investigators have developed the Pancreatic Breath Test (PBT) as an alternative to the secretin stimulation test. The breath test uses a tracer dose of sodium 13C-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreatitis by a meal (liquid Ensure). A normal pancreas releases unlabeled bicarbonate upon stimulation, decreasing the ratio of 13C/12C of exhaled carbon dioxide. This ratio will change much less in a diseased pancreas.

A case-control study in 25 mild to moderate CP patients and 25 healthy controls will be utilized to show feasibility of the new breath test.

Eligibility Criteria:
Inclusion Criteria:

* Male of female greater than or equal to 18 years of age.
* Subjects must have the ability to give informed consent.
* Female subjects of child bearing potential must use a medically acceptable form of birth control and have a negative pregnancy test.
* For case subjects with mild to moderate chronic pancreatitis, they must have either an abnormal endoscopic ultrasound (greater than 4 abnormalities), an abnormal secretin stimulation test, an abnormal endoscopic retrograde cholangiopancreatography (ERCP), an abnormal CT scan of the pancreas (dilation of the main pancreatic duct or atrophy of the pancreas), a serum trypsin level \<29 ng/ml but \>20 ng/ml, or a fecal elastase of less than 200 mcg/gram stool but greater than 100 mcg/gram stool.

Exclusion Criteria:

* Females who are lactating or pregnant.
* Subjects with acute pancreatitis.
* Subjects known to have a significant medical and/or mental disease.
* Subjects receiving an investigational new drug within 30 days.
* Subjects on enzyme therapy, proton pump inhibitors, H2 receptor antagonists.
* Subjects who have had a recent febrile illness within 5 days of scheduled entry into the study. Body temperature must be normal for at least 72 hours before entering the study.
Drug-coating Balloon Treatment in Coronary Artery Disease

Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for DCB treatment

Exclusion Criteria:

* Pregnancy
* Contraindications to contrast media, antiplatelet therapy, or paclitaxel
* Expected life less than 12 months
* Cardiac shock
Randomized Controlled Clinical Trial of Hyperthermia and Hydrogen Peroxide 3% in the Treatment of Cutaneous Warts

Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc.

Hydrogen peroxide (H2O2) is a commonly used disinfectant for skin debridement. It has been reported that high concentration of H2O2 (45% H2O2) is effective in the treatment of warts vulgaris, however, high concentration of H2O2 will cause more local pain, itching and burning sensation. 3% hydrogen peroxide is commonly used as skin debridement disinfectant.

The purpose of the study is to evaluate the efficacy and safety of 44℃ hyperthermia combined with 3% hydrogen peroxide in treating verruca virus.

Mild local Hyperthermia with a certain temperature range has been successfully used to treat some diseases. The warm treatment is usually "all or nothing". "All" means that all viral warts are removed after "warm" treatment, including rashes in non-treated areas. "Nothing" means that some viral warts do not respond to heat. Therefore, further enhancing the therapeutic effect of warmth and improving the reaction of some patients is the priority. Cellular experimental studies have found that low concentrations of dioxygen can promote the secretion of a keratinocyte series of inflammatory factors induced by warming. A randomized parallel control design was used to compare the efficacy of hyperthermia combined with hydrogen peroxide therapy and single use of hyperthermia and hydrogen peroxide alone in the treatment of viral warts. Primary analysis: Modified ITT (all randomized patients receiving ≥1 treatment).Missing data: Multiple imputation using chained equations (MICE)

.Between-group comparisons: ANOVA with Tukey posthoc test for continuous variables; Chi-square with Bonferroni correction for categorical variables.Survival analysis: Cox proportional hazards model adjusted for baseline lesion size

Eligibility Criteria:
Inclusion criteria: The participants were between 16 and 65 years of age, had a clinical diagnosis of viral warts (including common warts, plantar warts, or condyloma acuminatum), and could understand and sign informed consent.

Exclusion criteria: presented with clinically atypical warts; had immunocompromised status or a history of HIV infection; received HPV vaccination within the past 6 months; used immunomodulators, immunosuppressants, or systemic corticosteroids within defined timeframes (4 months and 1 month, respectively); underwent local therapies (e.g., laser, cryotherapy, retinoids) on or near warts within protocol-specified intervals; had a history of cutaneous malignancies or current precancerous lesions; exhibited active dermatologic/systemic diseases (e.g., psoriasis, eczema) or skin conditions (e.g., sunburn) potentially increasing study risks; or were deemed ineligible by investigators for other medical or logistical reasons.
The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality

This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Were between the ages of 18-65 years old
* Resided in the city center
* Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
* Had no clotting or bleeding disorders
* Were not undergoing dialysis treatment during the study period
* Had no ulcers, physical deformities or foot calluses
* Had no history of analgesic medication, except for medication used for DPN
* Had no physical diseases, cognitive deficiencies or psychiatric disease diagnosis that would prevent understanding of the questions on the scales used for data collection.
Olmesartan Medoxomil in Hypertension and Renal Impairment

This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.


Eligibility Criteria:
Inclusion Criteria:

* Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
* Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

Exclusion Criteria:

* Malignant hypertension or sitting BP greater than 180/109 mmHg;
* Severe heart failure, severe renal disease;
* Recent history of myocardial infarction, stroke or transient ischemic attack;
* History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
* Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
* Treatment with dis-allowed medication;
* Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
* History of drug and/or alcohol abuse
Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome

Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention

All the patients will be selected and examine from the outpatient clinic of Oral and Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.

Electromyography examination will be conducted in the department of neurophysiology department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to TMJ disorders All patients involved in this study will be divided into three groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry needle, and Botox injection.

for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 weeks

Eligibility Criteria:
Accepts Healthy Volunteers

Inclusion Criteria:

* Healthy Volunteers
* MPDS patient
* Adult patients of both sexes, aged from 15 to 60 years
* signs and symptoms of pain or muscles spams
* Trigger points in masticatory muscles
* Patients had not received any other form of surgical treatment related to TMJ disorders
* Cooperative patient

Exclusion Criteria:

* Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia
* Edentulous patients, and total dental prosthesis.
* Psychologically disturbed and mental disturbance patients
* major systemic disorders (- Valvular heart disease: avoid indwelling needles)
* seizure patients
* A confirmed or suspected diagnosis of an inflammatory disorder and autoimmune.
* Patient on Medication (insulin- corticosteroids, nonsteroidal anti-inflammatory therapy or narcotics, muscle relaxants, herbal medicines.)
* Analgesic or anti-depressants over the last 2 weeks.
* Any anatomical abnormality in TMJ.
* Pregnant women.
* Allergies to metals.
The Clinical Efficacy And Safety Of SkinStylus Microneedling System

The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.

1. The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.
2. Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.

Eligibility Criteria:
Inclusion Criteria:

1. at least 23 years old
2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Exclusion Criteria:

1. Pregnancy or chance of pregnancy
2. Currently taking Coumadin/Warfarin® or heparin
3. Diagnosis of any type of bleeding disorder
4. Any history of keloid formation
5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
6. Diagnosis of mental disorders requiring inpatient treatment
7. Presence of metal implants around the proposed treatment areas
8. Diagnosis of any undefined wasting disease (Cachexia for example)
9. Diagnosis of an active infection in the treatment area other than mild acne
10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
11. Diagnosis of severe cardiovascular and cerebrovascular disease
12. Diagnosis of renal failure
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries

Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-8 years
* ASA I\&II
* Undergoing lower abdominal surgeries for example hernia repair and circumcision

Exclusion Criteria:

* Children with chest infection, respiratory disease, cardiac disease
* Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
* Parental refusal
* Allergy to study drugs
The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones

We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.

Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.

Eligibility Criteria:
Inclusion Criteria (obese subjects with type 2 diabetes):

* treatment with DJBS
* written informed consent
* antidiabetic monotherapy/or diet
* \> 18 years old
* not anemic

Exclusion Criteria (obese subjects with type 2 diabetes):

* antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug.
* anemia

Inclusion Criteria (obese subjects without type 2 diabetes):

* Treatment with DJBS
* written informed consent
* not anemic
* HbA1c \< 6,0% or HbA1c \< 6,5% and normal glucose tolerance test and normal fasting plasma glucose (\< 6,0 mM)

Exclusion Criteria (obese subjects without type 2 diabetes):

* HbA1c \> 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose \> 6,0 mM
A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).

Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.

In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age,
* Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
* Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,
* Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study,
* Patient must be covered by a social security scheme,
* Patient must be treated by one of the practitioners of the centre (at office or at hospital).

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
* Patients unable to understand scope of study or patients unwilling to participate in study.