cyrilzakka/clinical-trials huggingface dataset:
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Same Wrinkle Severity (either both Moderate \[3\] or both Severe \[4\]) of marionette lines and upper peri-oral rhytids

Exclusion Criteria:

* Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
* Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the Nasolabial Fold area
Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer

This exploratory study aims to evaluate the effect of a self-compassion training developed for health professionals on leaders of self-help groups.

Hypothesis/primary goal: An online group intervention adapted from the "Self-compassion for health-care communities program" validated for health professionals leads to an increase in self-compassion among leaders of cancer self-help groups. Secondary goals: level of self-compassion at the end of the course as a mediator for therapeutic variables after 6 weeks, decrease in caregiver fatigue, secondary traumatic stress/burnout risk, personal distress and sick leave, decrease in fears of self-compassion/compassion for others; increase in mindfulness, self-efficacy, compassion for others and resilience; direct costs; safety;

Intervention:

Online group intervention: led by a certified mindfulness teacher for Mindful Self-Compassion and additional qualification in Self-Compassion in Healthcare Communities (duration: 6 weekly appointments of 90 min each); control intervention: waiting group


Eligibility Criteria:
Inclusion Criteria:

* Group leaders of a self-help group for cancer patients
* written informed consent

Exclusion Criteria:

* Medical or mental condition that, in the opinion of the investigator, does not allow the participant to take part in the study or to provide a legally valid signature of the informed consent (e.g. insufficiently controlled pre-existing mental illness or post-traumatic stress disorder)
* Lack of willingness to store and share personal health data as part of the protocol
* Participation in another mindfulness study
* Lack of knowledge of German
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy

The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.

Study type : Interventional Study Design : Allocation: Randomized Control: no treatment Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Primary Outcome Measures : Heart rate variability(HRV) Index

Secondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension Questionnaire(EQ-5D)

Eligibility Criteria:
Inclusion Criteria :

* Established Cardiac Autonomic Neuropathy in type 2 diabetes.
* aged 20 years to 80 years
* Capable of giving informed consent

Exclusion Criteria :

* History of other significant disease such as the nerve system (Parkinson's disease, epilepsy, multiple sclerosis), hepatic disease, hypothyroid, etc Other medical condition or treatment likely to affect the autonomic nerve system
* HbA1C \> 11%
* Not controlled hypertension (SBP≥160mmHg, DBP≥100mmHg)
* Diagnosed ketoacidosis within 4 weeks
* Unstable cardiac disease (unstable angina or myocardial infarction )
* Pregnancy
* Involvement in other clinical trial in last 4 weeks
* Known or suspected sensitivity to trial products
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential.
* Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information.
* Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening.

Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.

* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
Coping Strategies with Pain Among Older People

Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. The study also aimed to explore cultural differences in pain experience and management.

Methods:

337 older adults with chronic pain participate 100 from Turkey, 131 from Croatia and 106 from Romania. Semi-structured interviews will explore four main topics, including factors influencing pain, coping strategies, management strategies, and health-related quality of life.

The questionnaire which was prepared by researchers will be performed by older adults. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* women and men aged between 65-85 years
* living in their own homes or in a nursing home
* older adults with chronic pain for at least 6 months,
* independent in activities of daily living, and independent in walking (with or without assistive walking devices).

Exclusion Criteria:

* Elderly adults with communication problems
CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children

The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 7 years months to 11 years;
* Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)

Exclusion Criteria:

* Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker

Acute kidney injury (AKI) is characterized by a rapid decrease in renal function. It is frequent in hospitalized patients and its incidence is higher in critically ill patients. It is associated with high rates of morbidity and mortality.

AKI affects over 13 million people per year globally, and results in 1.7 million deaths. It is diagnosed in up to 20% of hospitalized patients and in 30- 60% of critically ill patients. It is the most frequent cause of organ dysfunction in intensive care units and the occurrence of even mild AKI is associated with a 50% higher risk of death. AKI has been associated with longer hospital stays, in-hospital mortality, cardiovascular events, progression to chronic kidney disease and long-term mortality. It results in a significant burden for the society in terms of health resource use during the acute phase and the potential long-term sequelae including development of chronic kidney disease and kidney failure. Yunos et al. have focused on chloride, which is the most abundant strong anion in extracellular fluid. Progression of hyperchloremia in the ICU was identified as a predictor of increased mortality in a large retrospective cohort study of critically ill septic patients. Sadan et al. have shown associations between hyperchloremia and an increased incidence of AKI in patients with subarachnoid hemorrhage, as well as in patients who have undergone abdominal surgery. Abnormal blood chloride concentrations were associated with metabolic acidosis, which may worsen patient outcomes. Moreover, hyperchloremia may be caused by inappropriate fluid management with chloride-rich solutions.

Importantly, chloride-rich solutions were reportedly associated with hyperchloremia and major adverse kidney disease, including death, in intensive care settings. Urine samples are relatively easy to collect in ICU, and real-time urinary electrolyte monitoring device is available for clinical use. In addition, recent development of urinary AKI biomarkers has enabled clinical evaluation of kidney function. Komaru et al. examined associations among urinary chloride, mortality, and AKI incidence in ICU patients and concluded that lower urinary chloride concentration was associated with increased mortality and incidence of AKI in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age from 21 years old and above.
* No history of chronic kidney disease (CKD).

Exclusion Criteria:

* Age under 21 years old.
* Patients leaving the ICU within 24 hours for any reason.
* Anuric patients.
* Patients on maintenance hemodialysis.
* Patients those without day 1 urinary or blood tests.
* Refusal of patient or his/her relative participation in the study
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).


Eligibility Criteria:
Key Inclusion Criteria:

* Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
* Female patients must be:
* postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
* surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* abstinent, or
* if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

* Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
* Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
* Patient has a history of diverticulitis within 6 months prior to Prescreening
* Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.
Dermatosis Papulosa Nigra

DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face.

The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Able to give informed consent.
* Desires removal of lesions.
* Willing to come back for six week follow-up.
* Willing to fill out post operative questionnaire.
* At least 4 lesions less than 7 mm.
* Diagnosis of Dermatosis Papulosa Nigra (DPN)

Exclusion Criteria:

* Less than 18 years of age.
* Pregnant.
* Sensitive to laser energy.
* History of Collagen Vascular Disorders.
* History of Keloids.
* History of post inflammatory hyperpigmentation.
* Incarcerated.
* Unable to give informed consent.
* Unable to follow up for post operative evaluation.
* Unable to complete patient visual analogue scale.
* Unable to understand consent process or risks.
* Unable to accept risk of scar, infection, minor bleeding, permanent or prolonged hyperpigmentation and hypopigmentation.
AMNIOmics: A Prenatal Rapid Genome Validation Study

The purpose of this study is to validate Whole Genome Sequencing (WGS) on amniotic fluid to reduce the time to diagnosis and enhance the care for the fetus/neonate.


Eligibility Criteria:
Inclusion Criteria

* Fetus with multiple anomalies/suspected genetic disease.
* Pregnant patient already planning on having an amniocentesis for another reason separate from this study.

Exclusion Criteria

* Parents under the age of 18.
* Parents lacking the capacity to consent.
* Institutionalized (i.e., Federal Medical Prison).
Monitoring Ovarian Cysts in Pregnancy

This prospective study will primarily aim to determine what monitoring is required of ovarian cysts when they are diagnosed in pregnancy, as well as what intervention, if any, is necessary. It also aims to identify the prevalence of ovarian cysts in pregnancy and the nature of these cysts, as well as their natural history throughout pregnancy.

The Royal College of Obstetricians and Gynaecologists currently publish guidelines for the management of ovarian cysts in both pre and post-menopausal women. The guidelines for pre-menopausal women do not specifically include pregnant women, and it is known from previous research that the characteristics of ovarian cysts can differ in pregnancy, and therefore appear different on ultrasound scan. Also, where intervention is needed, it is usually surgical which can have high risk implications in pregnancy.

The study will be conducted in the Early Pregnancy and Acute Gynaecology Unit at St. Thomas' Hospital. Any woman who presents with symptoms in early pregnancy (less than 18 weeks) is offered a transvaginal ultrasound scan. If, on this scan, they are found to have an ovarian cyst, they will be considered for the study. Once the ovarian cyst has initially been diagnosed, a confirmatory scan will be carried out by one of the investigators (ie. a clinical fellow, consultant gynaecologist or senior sonographer).

If the cyst is benign in nature and not the cause of acute symptoms, three more transvaginal scans will be carried out by one of the investigators at approximately 12 weeks and 20 weeks (in line with the nuchal translucency scan and anomaly scan), then at 6 weeks post partum. It is intended that all these patients will be managed without surgical intervention.

If there are concerns that the cyst is malignant, the participant would be investigated via the already established pathways. If the participant is at any point in acute pain and the cyst is thought to be the cause of this eg. ovarian torsion or cyst rupture, then a clinical decision would be made regarding surgical intervention.

The total study period will be up to 16 months. This includes a 6 month recruitment period, then following up each participant until 6 weeks post delivery.

Eligibility Criteria:
Inclusion Criteria:

- Age 16-50 Pregnant Scanned in the Early Pregnancy Unit at St. Thomas' Hospital (either as a walk in patient / a ward in-patient / referred from A\&E or another speciality) At least one ovarian cyst (excluding a corpus luteum)

Exclusion Criteria:

- Age \<16 (so as to avoid problems with consent / Gillick competence) Not pregnant (ie. attending the unit with acute gynaecology problem or for follow up after a miscarriage) Lacks capacity to consent Corpus luteal cyst only on ultrasound scan
Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

An international study in which patients with GHD were randomized to receive somatropin at a dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.


Eligibility Criteria:
Inclusion Criteria:

Patients may be included in the study only if they meet all of the following criteria:

1. Adult males and females with GHD, arising during adult life from pituitary ablation or failure, onset of GHD have taken place at least 1 year before entering the study, or,
2. Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood.
3. Demonstrated GHD as documented by a negative response to a standard GH stimulation test within the last 5 years previous year (see Section 3.4.3, part b). Maximal peak must be less than 3.0 ng/ml.
4. Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary.
5. Have given informed consent.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

1. Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes.
2. Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete.
3. Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives.
4. Patients thought unlikely to comply with the protocol.
5. Patients taking an investigational drug in the previous month.
GoalNav® Clinic Module - Pilot Trial

This is a pilot study to test the feasibility of GoalNav® Clinic, an Electronic Data Capture platform which is specifically designed to collect data on patient goals, live in a clinical setting.

Goal Attainment Scaling (GAS) is an individualized outcome measure that quantifies the effects of an intervention based on personalized goals.

Ardea Outcomes has developed an electronic data capture system called GoalNav® Clinic that is designed to capture GAS data (individual goals) in addition to other outcome measures that is useful to the doctor such as assessment information, patient demographics, cognitive status, etc..

With the help of a study doctor and/or a member of the research team trained in the process of conducting GAS interviews, patients and/or care partners set goals that are meaningful and relevant to them or their loved one's condition. Goals are then followed up in three months, and ratings are provided by the GAS interviewer and patient and/or care partner.

Eligibility Criteria:
Inclusion Criteria:

* a new or returning patient who has been referred and has a pre-scheduled appointment to the study doctor's clinic for a geriatric assessment
* of any age, with or without a disease diagnosis/memory complaint
* the patient is accompanied by a family member or friend who is willing to participate
* the patient and/or their care partner must be able to respond to questions in English
* the patient and their care partner give informed consent

Exclusion Criteria:

* the patient does not have a family member or friend who is willing to participate
* neither the patient nor their care partner can respond to questions in English
* either or both the patient and care partner decline to provide informed consent
* the study doctor deems that the patient and/or care partner is not suitable for the study
* either the patient or their care partner indicates on the informed consent form that they do not wish to be contacted by email or by telephone