cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)

With the development of medical technology and the improvement of life treatment, people's concept of aging is also changing, people of all ages are constantly pursuing a young and healthy life, the use of lasers and fillers to correct facial wrinkles has become more and more common. For the use of fillers to correct facial wrinkles, the efficacy and safety have been fully established, to the extent that it is a minimally invasive treatment, due to its short operation time and rapid recovery, it is considered a very effective treatment for facial wrinkles.

Collagen is a kind of natural protein. As the main component of skin tissue, it has the advantages of good biocompatibility, degradability and low immunogenicity, and is an ideal material for correcting facial soft tissue defects. Collagen is implanted under the skin in a non-surgical way to increase the capacity of the dermis tissue, thus achieving the purpose of smoothing wrinkles, improving facial defects, and sculpting perfect skin. The medical collagen filling agent of Filaman (Changchun) Pharmaceutical Biotechnology Co., Ltd. consists of 3.5% bovine collagen It is composed of 0.3% lidocaine hydrochloride saline suspension, and is filled by injection to repair the shape and correct the contour to achieve satisfactory results. The product is eventually completely degraded in the human body, and the expected absorption time is 6-12 months.

In accordance with the requirements of the Medical Device Registration and Filing Management Measures, the Medical Device Clinical Trial Quality Management Standards, the Clinical Trial Registration Review Guidelines for Facial Injection Fillers (Draft for Comment), the Clinical Trial Design Guidelines for Medical devices, and the ethical principles of the Declaration of Helsinki of the World Medical Congress, To maximize the benefit of the subject and avoid as much harm as possible.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old (including 18 and 65 years old), regardless of gender; Intentional correction of forehead wrinkles (crow's feet);

Exclusion Criteria:

* Received bovine collagen fillers or hyaluronic acid within 12 months prior to enrollment

Facial area of calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA) or plastic therapy

Domain therapy, or subjects who plan to receive such therapy during study participation;
A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension

This study is a single arm trial with before-after comparison design. Three groups of patients with hypertension will be recruited: not taking antihypertension drugs and having normal renal function, taking antihypertension drugs and having normal renal function, and having abnormal renal function without regards of antihypertension drugs use. Each group includes 30 patients. Based on renal function test, the investigators provide the Manlikang containing potassium chloride to patients with normal renal function, and provide the Manlikang not containing potassium chloride to patients with abnormal renal function. All hypertension patients will use the formula salt with very low sodium (Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the decrease of patients' systolic blood pressure at the end of the trial.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 75 years old
* No planning to move out of the community in the next three months
* Not cooking at home less than 3 times or one day during the study
* Willing to participate in the study and sign informed consent

Exclusion Criteria:

* Acute myocardial infarction, history of stroke in the past 3 months, history of malignancy or expected lifetime less than 1 year.
* Hypercortisolism or aldosteronism
* Acute disease, such as upper respiratory infection, fever and diarrhea.
* Incapable of communicating, such as deaf and dumb, dementia, mental disorder.
* Families taking salt substitute currently
* Not willing to use Manlikang in family
* Liver disfunction
* Anyone with abnormal serum potassium in family
* Anyone using potassium-retaining diuretics in family
Validation of RPVi as a Parameter to Predict Fluid Responsiveness

This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of consent
* Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
* Arterial line and other standard of care line placement indicated as part of the scheduled surgical procedure

Exclusion Criteria:

* Patients diagnosed with or history of heart failure, angina, pulmonary heart disease, rheumatic heart disease, cardiomyopathy, congenital heart disease, or valvular heart disease.
* Patients scheduled for or has had a liver transplant
* Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study.
* Patients with cardiac arrhythmias
* Patients with intracardiac shunts
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
* Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
* 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)

Exclusion Criteria:

* History of atopic dermatitis of the face
* Granulomatous perioral dermatitis
* Facial acne, rosacea, facial demodicosis
* Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
* The use of topical or systemic medications that could affect the course of treatment and/or evaluation
* Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
* Use of fluorinated toothpaste
* Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
* Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
* History of or suspected hypersensitivity to any ingredient of the study drugs
* Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia

The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS).

Background and study aim: Endoscopic submucosal dissection (ESD) of large colorectal lesions requires the patient to be in a still position for a long time. Both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (ARAEs), especially in frail patients. Conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. Spinal anesthesia (SA) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. As the use of SA in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of SA in large (\>35 mm) recto-sigmoid lesion ESD.

Patients and methods: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). The secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, ESD-related adverse eventss, length of hospital stay, and median ESD duration.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* American Society of Anaesthesiologists (ASA) score I-IV
* ability to give informed consent

Exclusion Criteria:

* age \<18 years
* ASA score V
* allergy to medications used for spinal anesthesia
* pregnancy
* breastfeeding
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI \> 30 kg/m2 to ≤ 40 kg/m2
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Inability to tolerate subcutaneous (SC) injections
* Inability to be venipunctured and/or tolerate venous access
* Any sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply
A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.


Eligibility Criteria:
Inclusion Criteria:

* Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
* Active psoriatic skin lesions of plaque psoriasis (Ps)
* Are a candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Are unable to commit to the photography schedule for the duration of the study
* Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure

The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;
3. Patients are voluntary and signed informed consent.

Exclusion Criteria:

1. Pregnant women or plan to;
2. Participate in any drug clinical trials within 3 months;
3. Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
4. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
5. Patients refused to comply with the requirements of this study to complete the research work;
6. According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).
Quantum Menstrual Health Monitoring Study

The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.


Eligibility Criteria:
Inclusion Criteria:

* Regularly menstruating, PCOS or athlete participants aged 18-45
* Negative pregnancy test at the beginning and at the end of each cycle
* Cycle lengths 24-34 days
* Knowledge of previous 3 cycle lengths
* Able to travel to Calgary Clinic for regular ultrasounds during the study period

Exclusion Criteria:

* For regular cycles

  * Anovulation in the last 3 cycles
  * Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
  * Known conditions that impair ovulation or fertility: polycystic ovarian syndrome, endometriosis, pelvic inflammatory disease in the last year, pituitary adenomas, exclusively breastfeeding
  * Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
  * Currently pregnant
* For PCOS and athlete groups:

  * Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
  * Known conditions that impair ovulation or fertility: pelvic inflammatory disease in the last year, pituitary adenomas, exclusive breastfeeding
  * Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
  * Currently pregnant
Accelerated Mandibular Molar Protraction: Piezocision at the Time of Molar Protraction or Later?

This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and root resorption in patients treated by molar protraction with piezocision performed early at the time of protraction (Group 1), piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar protraction (Group 3).

Detailed Description: Thirty-five subjects who presented with bilaterally extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 20 subjects /20 molars where piezocision was performed immediately before molar protraction; group 2 consisted of 20 subjects/ 20 molars where molar protraction was carried on after 3 months of molar protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where protraction was carried out with no piezocision.

After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Periodontal parameters were measured and lower molar root resorption was assessed using Perapical radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 19 to 30 years
* Bilaterally extracted mandibular first molar (first molar extracted more than one year ago and with a residual extraction space of more than 6 mm).
* Class 1 malocclusion where molar protraction is indicated.
* All permanent teeth are present except for the extracted mandibular first molars.
* Healthy periodontium (gingival index score ≤ 2, plaque index score ≤ 2 and probing depth \< 4mm)

Exclusion Criteria:

* Previous orthodontic treatment
* Any systemic disease
* Smoker
* Poor Oral hygiene
A Study of Nopan Treatment of Acute Suicidality

Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.


Eligibility Criteria:
Inclusion Criteria:

* suicidal behavior or ideation (BSI\>6)

Exclusion Criteria:

* ECT history within the last month
* psychotic features within the last 3 months
* history of schizophrenia, substance or alcohol abuse within the last two years
* benzodiazepine dependence within the last two years
* any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
* pregnant women
* patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.
The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease

Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor quality of life. Recent international guidelines have stressed the importance of dyspnea alleviation and improvement exercise tolerance as a means of enhancing quality of life and other long term outcomes in this population. Modern pharmacotherapy is the first step in symptom management but the overall impact of bronchodilator therapy is relatively small. Exercise training remains the most effective treatment for ameliorating dyspnea and improving exercise endurance and was the main focus of this study.

The main objectives of the study were:

1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise before and after exercise training (EXT) compared with an untrained control group. By multiple regression analysis, the investigators will establish the main contributors to dyspnea relief after EXT.
2. To compare the magnitude of change in endurance during constant work rate cycle exercise with those measured during walk tests and the endurance shuttle walk test after EXT relative to control. To evaluate which test (constant work rate cycle, six-minute walk test, or endurance shuttle walk test) is the most sensitive test for measuring changes in endurance after EXT versus control.
3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load cycling with a variety of other activity-related dyspnea questionnaires. To evaluate which of these measurements is the most sensitive for examining changes in perceived discomfort during exercise.
4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory panic, self-efficacy) to the perceived improvement of symptoms following EXT. The investigators will use multiple regression analysis to examine associations between changes in perceived dyspnea and changes in anxiety and self-efficacy measured by validated questionnaires and Borg intensity ratings?


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD
* clinically stable
* presence of activity-related dyspnea (Baseline Dyspnea Index \< 9)
* 40-80 years of age

Exclusion Criteria:

* other significant disorders or diseases that could interfere with conduct of the intervention or tests
* body mass index \< 18 or \> 40 kg/m2
A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.

The study of extended total mesopancreas excision(eTME) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.

The objectives of the study are as follows:

1. To evaluate the perioperative safety of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.
2. To demonstrate the prognosis of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.
2. Patients with accessible medical records

Exclusion Criteria:

1. Patients with unknown chemotherapy sequence or status
2. Patients with history of previous malignant tumors
3. Patients with distant metastases