cyrilzakka/clinical-trials huggingface dataset:
Multi-Center, Clinical Evaluation of the Cutera Secret RF Device

The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.

This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, age 18 and older
3. Willing to undergo treatments with Secret RF.
4. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
5. Subject must adhere to the follow-up schedule and study instructions.
6. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment area during the study and has no intention of having such procedures performed during the course of the study.
7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
8. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
2. History of clotting disorders and/or current use of blood thinning medications.
3. History of autoimmune disorders or diabetes.
4. Cardiac pacemaker or active implantable metal device in the treatment area.
5. Allergies to metals i.e. gold.
6. Has a history of squamous cell carcinoma or melanoma in the treatment area.
7. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
8. History of any disease or condition that could impair wound healing.
9. History of keloid formation or abnormal/delayed wound healing.
10. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
11. Use of topical agents one week prior to treatment that may cause facial sensitivity.
12. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne

The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.

Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.

This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* No known active skin infection.
* Presence of mild or moderate acne on face (clinical diagnosis or self-report)
* Willingness to give written consent and comply with study procedures.

Exclusion Criteria:

* Active skin infection.
* Inability to understand instructions or procedures involved.
* Known allergy to ingredient(s) in products being used for study.
* Pregnant women, prisoners, and vulnerable populations.
* Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
* Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator.
Antioxidant Functions of Lipoic Acid

The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

As per Brief Summary

Eligibility Criteria:
Inclusion criteria:

* Lipid criteria for inclusion are a plasma LDL between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl)
* Less than 2 coronary risk factors, and already on a cholesterol-lowering diet.

Exclusion criteria:

* Overt or clinical atherosclerosis
* Diabetes
* Currently taking cholesterol-lowering medication.
* Subjects with other lipid disorders
* Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.
Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?

Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective diagnostic EGD
* American Society of Anesthesia (ASA) criteria to be class 1 to 2

Exclusion Criteria:

* History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
* American Society of Anesthesia (ASA) criteria to be class 3 to 4
* Pregnancy
* Alcoholism
* Drug abuse
* Taking psychotic medications
* Allergy to midazolam.
A Single-center Study of Setmelanotide in Patients With Prader-Willi Syndrome

This is a Phase 2, single-center, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 26 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of Prader-Willi Syndrome (PWS)
* Age 6 to 65
* BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex
* Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
* Patient and/or guardian is able to communicate well with the Investigator, understand and comply with the requirements of the study, and understand English and sign the written informed consent.

Exclusion Criteria:

* Use of weight modulating medications
* Abnormal HbA1c, eGFR, ALT, AST, bilirubin, T4 values
* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
* Participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose
* Hypersensitivity to setmelanotide
* Diagnosis of severe psychiatric disorders
* Pregnant and/or breastfeeding

Other protocol defined Inclusion/Exclusion criteria may apply.
Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma;
2. According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
3. Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
4. Male or female, age between 18 and 75 years old ;
5. ECOG PS 0\~1；
6. Expected survival period ≥ 3 months or more
7. Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
8. Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
9. Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
10. The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds
11. No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
12. Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered;
13. Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
15. Sign the informed consent.

Exclusion Criteria:

1. Pregnancy, nursing mothers, or female patients with fertility but no contraception.
2. Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
3. Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
4. With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
5. With a bleeding tendency
6. Researchers believe that patients should not participate in this test.
Impact of a Mindfulness-Oriented Psychoeducational Program on the Mindfulness, Anger and Interpersonal Relationship Styles

Aim: This study aimed to investigate the impact of a mindfulness-oriented psychoeducational program on nursing students' levels of mindfulness, anger, anger expression, and interpersonal relationship styles.

Background: Mindfulness of anger, which significantly influences interpersonal relationships, is especially crucial for the professional practice of nursing. Although numerous studies have explored anger and interpersonal relationships among nursing students, research on the impact of mindfulness interventions within this context remains limited.

Design: This study was a single-blind, randomized controlled trial with pre-test, post-test, and one-month and three-month follow-up assessments.

Methods: The study was conducted at the Faculty of Nursing, Aydın Adnan Menderes University, during the 2022-2023 academic year with first-year nursing students. A total of 84 students (Experimental: 42, Control: 42) were included in the study sample, determined through randomization. The experimental group participated in a six-week mindfulness-oriented psychoeducational program, with weekly sessions lasting 60 to 90 minutes. Data were collected using the Personal Information Form, the Mindful Attention Awareness Scale (MAAS), the Trait Anger/Anger Expression Inventory (TAXI), and the Interpersonal Style Scale (ISS).


Eligibility Criteria:
Inclusion Criteria:

* To have higher mean scores of "trait anger"

Exclusion Criteria:

* Completion of formal training in mindfulness, anger, and interpersonal relationships
Efficacy and Tolerability of Zoledronic Acid With Radiotherapy in Pts With Advanced Osteolytic Bone Lesions

It is the aim of this multicentric clinical study to assess the efficacy and tolerability of zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone lesions in terms of the reduction of pain and analgesic consumption.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of at least one cancer-related bone lesion in cancer patients, confirmed by X-ray, MRT or computer tomography
* Severity of pain ≥ 5 on item 3 of the BPI which is caused by the bone lesion(s) and requires radiotherapy
* Adequate liver function - serum total bilirubin concentration less than 1.5 x the upper limit of normal value
* Expected survival time ≥ 6 months
* If the patient is of child-bearing potential: negative pregnancy test at screening
* ECOG performance status of 0, 1 or 2.
* Written informed consent

Exclusion Criteria:

* Prior treatment with an oral bisphosphonate for more than 3 months or more than 3 intravenous (i.v.) bisphosphonate applications
* Bisphosphonate treatment within 6 months before study start
* Previous radiotherapy of the painful areas to be irradiated. An initiation of radiotherapy for the target area(s) up to 3 days at maximum prior to the first infusion is allowed.
* Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
* Initiation of a new chemotherapeutic treatment regimen during the last 2 weeks prior to the first infusion of trial medication
* Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dL)\]
* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L).
* Patients with clinically symptomatic brain metastases
* History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
* Pregnancy and lactation
* Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device \[IUD\], vaginal diaphragm or sponge, or condom with spermicide)
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Other protocol-defined inclusion/exclusion criteria may apply.
Mass Treatment T Solium Community Study

Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.

This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.

Eligibility Criteria:
Inclusion Criteria:

* All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)

Exclusion Criteria:

* Pregnancy (for antiparasitic treatment only).
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)

The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
* Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must include the most recent assessment) above 110 g/L.
* Males or females \> 18 years of age at the time of informed consent
* Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential
* The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be \> 31.8 pmol/L (300 pg/mL) and \< 84.8 pmol/L (800 pg/mL)
* The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be \> 2.1 mmol/L (8.4 mg/dL)
* Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before ANY study specific procedures are initiated

Exclusion Criteria:

* Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1
* Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
* Hypersensitivity to Sensipar or any of its components
* Are currently breastfeeding
* Have had a parathyroidectomy in the 3 months before day 1
* Experienced a myocardial infarction within 3 months prior to day 1
* Have had a red blood cell transfusion within 3 months prior to day 1
* Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
* Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
* Have a disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements
* Have previously enrolled in this study or participated in other trials of Sensipar
Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children

The purpose of this pilot study is to improve inpatient monitoring of severely-ill children admitted to the hospital in low resource settings at Kenyatta National Hospital in Nairobi, Kenya. Given the high ratio of patients to medical staff in these settings, the lack of reliable patient monitoring tools, and the high rate of early inpatient mortality, we will prospectively train parents as monitoring aids of their hospitalized children. Early recognition and intervention in critical illness is important to avoid (further) organ failure. Parents will be taught how to assess their child's mental status, work of breathing and capillary refill time which will inform a 3-point severity of illness scale. The severity of illness will be conveyed by the parents to the medical staff via color-coded flag system. The goal is to increase the healthcare provider patient reassessment rate according to patients' level of severity to assist in early recognition and treatment of patients' deterioration.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Kenyatta National Hospital with severe febrile illness which includes presumed malaria, sepsis or septic shock, pneumonia, meningitis or encephalitis
* Available adult caregiver
* Enrollment within the first 8 hours of admission to the pediatric ward (modified to 16 hrs later)

Exclusion Criteria:

* Primary cause of admission is major bleed or hemorrhagic shock, severe trauma or burn, major surgery, known congenital heart disease
* Previous study enrollment
* No available adult caregiver
* Caregiver unable to give informed consent
* Caregiver not proficient in English or Swahili
Evaluation of Local Anesthetic at Incision Site

Patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random.

The clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied.

Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess the timing of local anesthetic injection affects postoperative pain.

This is a prospective randomized-controlled pilot study of 100 pediatric subjects, recruited through Phoenix Children's Hospital and Pediatric Surgeons of Phoenix, who will undergo a laparoscopic appendectomy (LA) for acute non-perforated appendicitis. The reviewer and subject will be blind to the treatment to help prevent bias. The subjects will be randomized by envelope using a random number generator, and the infiltrated solution will be given to the surgeon by the pharmacy.

The subjects will be approached preoperatively and will be divided into three groups: pre-incisional injection of local anesthetic, post-incisional injection of local anesthetic, and (pre or post) injection of saline as the control.

All patients will have a standard 3 port laparoscopic appendectomy, port placement, port and instrument type, and operative technique will be determined by the surgeon's usual practice.

On induction, the following protocol will be utilized: a 2 mg/kg bolus of propofol, 1.5 mg/kg of lidocaine, 0.1 mg/kg of morphine, and 0.6 mg/kg of rocuronium. A standardized anesthetic, using a mixture of sevoflurane in oxygen and air, will be utilized. Once the appendectomy is complete, a single dose of 0.5 mg/kg of ketorolac will be given prior to extubation. A total of 0.5 mL/kg of 0.25% Bupivicaine or saline, up to a maximum of 30 cc, will be injected using a 22g needle. Pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; post-closure local will be injected intradermally after closure.

The subjects will be assessed for postoperative pain immediately upon wakening, and then 1, 2, 4, 8, 12, and 24 hours after the LA procedure by the bedside nurse by using the VAS and by measuring the total amount of opioid use.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between 9-17 years old

Exclusion Criteria:

* n/a