cyrilzakka/clinical-trials huggingface dataset:
Treatment Trial for Post-Thrombotic Syndrome

The purpose of this study is to determine if complex lymphedema therapy is effective in decreasing disease severity and improving quality of life in patients with post thrombotic syndrome.

Post thrombotic syndrome (PTS) has a spectrum of disease manifestations ranging from minor skin discoloration to severe skin changes and venous ulcerations. Pain is often a prominent symptoms and PTS impairs patient quality of life. Prevention of PTS using compression stockings has been emphasized. There is a paucity of validated, effective treatments for PTS once the condition develops.

While the pathophysiology of PTS is incompletely understood, chronic venous hypertension and insufficiency may increase the workload of the lymphatic system and result in over-capacitance with secondary damage and eventual lymphatic insufficiency. In selected patients with PTS, we have noted a symptomatic improvement in patients who receive lymphedema therapy to the limb.

Complex lymphedema therapy (CLT) is a noninvasive treatment that includes four key components: meticulous skin care, manual lymph drainage, compression therapy, exercises and patient education for home management and continuation of the treatment. These techniques are designed to enhance lymph flow through intact cutaneous lymphatics and reduce swelling and restore function in the affected limb.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Diagnosis of post thrombotic syndrome.
* Median life expectancy of greater than 2 years.
* Previous history of lower extremity deep venous thrombosis.

Exclusion Criteria:

* Acute venous thrombosis of the lower extremity within the last 180 days.
* Unable to participate in lymphedema therapy due to monetary, physical or transportation limitations.
* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women and women in their first post-partum month.
High Resolution Imaging for Early and Better Detection of Bladder Cancer

The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care.
* Must be willing and able to participate and provide written informed consent
* Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation

Exclusion Criteria:

* Patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures.
* Women with the possibility of having the pregnancy.
* Patients having acute infection.
* Person with Lidocaine sensitivity.
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Females, 18 years of age or older.
* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
* Signed informed consent form, which meets all criteria of current FDA regulations.
* If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, oral or implanted hormonal contraceptives).
* Weight within + 25% from normal for height and weight for body frame as described in Novum Standard Operating Procedures adapted from the "MetLife® Height and Weight Tablets", Copyright© 1993.

Exclusion Criteria:

* Females who are pregnant, lactating, or likely to become pregnant during the study.
* History of allergy or sensitivity to metronidazole, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
* Significant history or current evidence of chronic infectious disease, system disorder or organ disorder.
* History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
* Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives or hormonal replacement therapy).
* Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to dosing.
* Drug or alcohol addiction requiring treatment in the past 12 months.
* Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
* Positive test for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
* Positive test results for drugs of abuse at screening.
* Evidence of vulvovaginitis or cervicitis (e.g. Bacterial vaginosis, vaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or history of Herpes simplex or human papillomavirus).
* Vulvar or vaginal conditions that may affect absorption of the drug.
* Clinically significant abnormal findings on PAP smear within previous 12 months.
Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in German (Munich) or Portuguese (Porto)
* Scheduled for elective minor or intermediate risk procedure

Exclusion Criteria:

* ASA status 4
* History of drug abuse
* Pre-existing neurocognitive or psychiatric disorders
* Auditory Impairments, vision diseases or other diagnosed cognitive impairments
Snare-assisted POEM for Treatment of Esophageal Achalasia

POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years
* Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
* Signed written informed consent

Exclusion Criteria:

* ASA class \> Ⅲ
* Previous endoscopic or surgical treatment for achalasia
* Esophageal malignancy
* Pregnant
Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain

Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique.

1. To evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of ALAS,and compare its differences and advantages with traditional therapy.
2. To investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway.
3. To investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency.
4. To demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated Chinese and Western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.

Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for a grade I or II injury;
* Onset time≤48h;
* The patient aged between18 and 60, gender is not limited;
* The skin of the ankle joint on the affected side is intact, without breakage or ulceration;

Exclusion Criteria:

* Combined with ankle fracture;
* Grade III injury or complete ligament rupture;
* Those who cannot comply with the treatment program. Those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment;
* Those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.
A Comparison Between Two Types of Sealers in the Healing of Periapical Lesions

This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions.

The study sample will consist of 41 patients with 65 teeth with clear periapical lesions.

Root canal obturation will be applied for all patients. BioCeramic sealer will be applied for the experimental group only.

The changes of the dimensions of the periapical lesion will be assessed using CBCT radiographs; pre- and post- treatment changes for each group will be evaluated individually.

Periapical lesions is considered as the most common symptoms associated with infected root canals.

Recently, the BioCeramic sealer has been considered one of the most common endodontic sealer that possess antibacterial properties, so it can have an effective role in the healing of periapical lesions, as well as its ability to prevent periapical leakage due to its attachment to the dentinal walls and gutta-percha cones.

This study will evaluate the effect of BioCeramic sealer on the healing of periapical lesions and the changes of the dimensions of the lesions.

Root canal obturation with gutta-percha cones will be applied in the two groups: The control group will receive the AH Plus with lateral condensation technique, and the experimental group will receive BioCeramic sealer with single cone technique.

CBCT radiographs will be gotten before and after one year of the treatment to evaluate the periapical lesion dimensions changes.

Eligibility Criteria:
Inclusion Criteria:

* One maxillary anterior tooth with a clear periapical lesion at least.
* Normal anatomic features and straight or slightly curved roots.
* The treated teeth must have complete roots and a closed apex.
* The ability to isolate the teeth with a rubber dam and restore them.
* Good oral hygiene.
* Good systemic health.

Exclusion Criteria:

* Root caries.
* Root fractures or resorption.
* Signs of occlusal trauma on the treated tooth.
* Internal or external resorption.
* Active periodontal disease.
* Pregnancy or lactation.
Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Cancer

The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SABT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.

The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SBRT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. The schedule of SBRT is 25 to 50 Gy in 5 fractions and the PD-1 blockers are monoclonal antibodies targeted to PD-1 molecules on the T lymphocytes.

All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. LRPC confirmed by pathologic or imaging diagnosis and LAPC confirmed by pathology;
2. disease size ≥1 cm;
3. KPS≥70;
4. adequate hematological reserves, hepatic function, renal function and heart function;
5. expected survival \> 3 months.

Exclusion Criteria:

1. unconfirmed mass;
2. The upper abdomen was previously treated with radiotherapy;
3. the patients previously underwent immunotherapy of PD-1 or PD-L1 monoclonal antibody;
4. a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency or other immune-related conditions requiring long-term oral hormone therapy;
5. patients with active infectious disease, trauma and severe wounds;
6. patients with any mental disorder;
7. patients with other somatic comorbidities of clinical concern;
8. pregnancy and lactation.
Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma

This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with renal cell carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks.

The drug being tested in this study is called cabozantinib tablets. This tablet is being tested to treat people who have radically unresectable or metastatic renal cell carcinoma.

This study is an observational (non-interventional) study and will look at occurrence of adverse drug reactions (or adverse events) of cabozantinib tablets in the routine clinical setting. The planned number of observed patients will be approximately 300.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

Patients with radically unresectable or metastatic renal cell carcinoma who do not meet the following exclusion criterion are eligible.

Exclusion Criteria:

A patient who has a history of hypersensitivity to any component of cabozantinib.
FeetSee Thermal Images Collection Protocol

The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation.

The aim of this study is to collect a database of thermal images of the diabetic persons' feet, and non-diabetic control groups' feet images, which in turn will enable us to build a system based on a mobile thermal camera and a mobile application for possible indication of signs of inflammation in feet. Enrolled participants will undergo a detailed history and physical examination of the foot at the beginning of the procedure day. Then the thermal images of the patient's feet will be taken. Participants will be also asked to take thermal images of their feet according to very well-explained instructions provided by the sponsor. Thermal images using the reference thermal camera will be taken following the Feetsee thermal camera. The images will be unidentified, collected, and stored for the development and performance evaluation of the Feetsee device Algorithm. At the end of the study procedure, participants or their caregivers will receive a short questioner on their experience with using the study device.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

Group 1/2: Diabetic with/without ulcers

1. Male/Female, 18 years or older
2. Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.
3. Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist
4. For Group 1: Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment For Group 2: Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
5. Must be able to read, understand and sign the Informed Consent Form Control: Generally Healthy Non-diabetic

1. Male/Female, 18 years or older 2. No diabetes mellitus or other diseases that may have signs of polyneuropathy or impaired blood circulation in the foot. 3.No damage to the skin or the soft tissues of the examined feet. 4. Must be able to read, understand and sign the Informed Consent Form

Exclusion Criteria:

1. Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
2. Active Infection/Gangrene
3. Active malignancy
4. Immunosuppressive disease
5. History of alcohol or drug abuse
6. Pregnant women (verbal confirmation or confirmation obtained within current medical records)
7. Cognitive deficit
8. End-stage renal disease
9. History of amputation proximal to the Trans-metatarsal (TM) joint
10. Other issues that, at the discretion of the investigator, renders the subject ineligible for participation.
Interaction Between Immune Cells and Bacteria Associated With Periodontitis

This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.

Periodontitis is a prevalent, multifactorial inflammatory disease characterized by the interaction between microorganisms organized in biofilms on tooth surfaces and host immune cells, leading to an inflammatory destruction of the tooth-supporting tissues and - if left untreated - eventually tooth loss. Periodontitis affects up to 50% of the population in the United States of America, and is classified in an aggressive and a chronic form depending on genetic factors, age of onset, speed and severity of attachment loss.

The onset of periodontitis is caused by an immunologic imbalance between host immune cells and residing microorganisms in subgingival pockets. The host immune cells are capable of enhancing both a protective and a destructive inflammatory response towards the microorganisms through the release of inflammatory mediators e.i. proinflammatory and antiinflammatory cytokines.

The role of antibodies in periodontitis is also unclear. Some studies show an excessive antibody level against bacteria associated with periodontitis e.g. Porphyromonas gingivalis (P.g.).

In general, this study contributes to a profound understanding of the host immune cells role in the onset and pathogenesis of periodontitis by comparing healthy versus diseased donors immunologic responses toward pathogene and apathogene microorganisms and their genetic background.

Eligibility Criteria:
Inclusion criteria for chronic periodontitis donors:

* 50-60 years of age.
* Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
* Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
* Visible radiographic bone loss.
* Medically healthy donors.

Inclusion criteria for aggressive periodontitis donors:

* 19-40 years of age.
* Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
* Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
* Visible radiographic bone loss.
* Medically healthy donors.

Inclusion criteria for healthy donors: (age: 19-40 years; 50-60 years)

* No sign of inflammatory conditions or other general systemic diseases.
* Medically healthy donors.

Exclusion criteria for all groups:

* Pregnant and breastfeeding.
* Antibiotic treatment within 6 months.
* Suffer from periodontal manifestations caused by systemic diseases e.i. genetic diseases, haematologic anomalies or syndromes.
Renal Denervation for Uncontrolled Hypertension

This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

Eligibility Criteria:
Inclusion Criteria:

* BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
* concurrent treatment with 2 anti-hypertensive drugs

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using MDRD formula)
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of child bearing potential must have negative pregnancy test prior to treatment