cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants

The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.


Eligibility Criteria:
Inclusion Criteria:

* Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure \>140 or diastolic \>90 mmHg + day-time systolic blood pressure \>135 or day-time diastolic blood pressure \>85 mmHg)
* Metabolic syndrome (ATP III criteria)

Exclusion Criteria:

* Secondary arterial hypertension
* Severe liver or kidney disease
* Immunological disease
* Cardiac arrhythmias
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Is a healthy Chinese female.
* Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.

Exclusion Criteria:

* Has a history of known prior vaccination with an HPV vaccine.
* Has a history of severe allergic reaction that required medical intervention.
* Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
* Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
* Has a history of a positive test for HPV.
* Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma

the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients developed thigh soft tissue sarcoma, defined as lesion located below the plane of the lesser trochanter and above the plane of the femoral condyle.
2. received primary limb-salvage surgery at our center.
3. soft tissue sarcoma with only cortical contact of the adjacent bone based on preoperative imaging
4. minimum of 2-year follow up

Exclusion Criteria:

1. diagnosis was well differentiated liposarcoma
2. patients with metastatic disease at the time of presentation
3. soft tissue sarcoma displayed frank osseous invasion (eg. medullary canal invasion)
Immunotherapy of Cervical Cancer With V3-Cervix

The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

Cervical cancer (CC) is a malignant neoplasm that occurs in the cervix. Histologically, there are two main types: adenocarcinoma and squamous cell carcinoma. Cervical cancer is most common in middle-aged women (35-55 years of age), in 20% of cases it is found over the age of 65 years. Cancer of the body and cervix are the most common type of malignant tumor of female genital organs. It is believed that human papillomavirus (HPV) is the main risk factor causing cervical cancer. Cervical cancer combines surgical treatment, radiotherapy and chemotherapy. Current immunotherapies did not show much success. The prognosis depends on the stage of the disease: 5-year survival rate at the first stage is 78.1%, at the second stage - 57%, at the third - 31%, at the fourth - 7.8%. There is no specific cervical cancer marker, usually a panel of markers is used including CA125, beta-hCG, CEA, SCC, CA19.9 and CA27.29. The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

Eligibility Criteria:
Inclusion Criteria:

confirmed diagnosis of cervical cancer available baseline measurement of tumor size and burden presence of tumor markers associated with cervical cancer, i.e., CA125, beta-hCG, CEA, SCC, СА19.9 and СА27.29 -

Exclusion Criteria:

metastases to other sites hysterectomy

-
Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer

We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.

Endometrial cancers are among the epithelial malignancies of the lining in the uterine cavity. Standard treatment is surgical, which includes a hysterectomy. The invasion of carcinoma into the lymphovascular space (LVSI - lymphovascular space invasion) is considered a risk factor for the course of the disease Based on the recommended procedures of ESGO-ESTRO-ESP (2020) in the management of endometrial cancer, in the event of significant LVSI positivity, the female patients are included in the upper-medium risk group. A confirmation of LVSI in the preparation is of diagnostic, therapeutic and theoretical importance. During endoscopy approach, we use two types of uterine manipulators, namely the Koh-RUMI manipulator (Cooper Surgical) and the Hegar dilatator along with the McCartney tube (LiNA Medical). We analyzed data and compared the impact of intrauterine manipulators on the incidence of LVSI. In addition, we analyzed tumor grading, invasion and primary histology obtaining methods - curettage or hysteroscopy in correlation to incidence of LVSI.

Eligibility Criteria:
Inclusion Criteria:

* endometrioid endometrial cancer,
* planned primary surgical treatment - hysterectomy,
* medical condition enabling anesthesia and surgery,
* pre-surgical clinically-determined affecting of the uterine according to MRI or ultrasound - cT1a or cT1b

Exclusion Criteria:

* non-endometrioid type of tumor in definitive histology,
* stage 2 of a disease and higher,
* previous chemo or radiotherapy,
* inability to adequately complete the surgery,
* uterine perforation during surgery
Obese Patients With Untreated Dyslipidemias

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia


Eligibility Criteria:
* BMI must be greater than 27 and less than 40
* Patients with untreated dyslipidemia
* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
Optimal Protein Dose Per Meal During Weight Loss in Perspective to Maintaining Muscle Mass

The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. In addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.

Aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss.

The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men.

Methods: Forty women (\~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses. The muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* Postmenopausal women

Exclusion Criteria:

* Smoking
* Metabolic and/or chronic diseases
Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis

Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. Ultrasound (US) and landmark (LM) small \& medium joint arthrocentesis are both performed within the clinical setting. Both techniques are considered standard of care. Selection of which technique to use is dependent upon the physician's preference. There is currently limited data comparing the two methods. The investigators hope to determine if one modality is more effective in terms of success rate, number of attempts, and time to complete the procedure.

Patients presenting to the Emergency Department who are 18 years old or older, who do not belong to a vulnerable group, requiring small or medium joint arthrocentesis will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts to tap the joint, success rate, and time for procedure to be completed. The arthrocentesis will be performed by PGY-3 residents only. A 21 gauge needle will be used for the arthrocentesis.

Eligibility Criteria:
Inclusion Criteria:

* All patients who require an arthrocentesis of a small and/or medium joint (defined previously)

Exclusion Criteria:

* Coagulopathic patients
* Patients on anticoagulants
* Patients with cellulitis overlying the joint.
* Patients with artificial joints
* Adults Unable to Consent
* Vulnerable Populations
The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting

The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea-vomiting and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea-vomiting and the consumption of additional analgesic and antiemetic medications.

Robotic surgery provides several advantages in the field of surgery, including a three-dimensional view of the surgical site, the elimination of surgeon hand tremors, and enhanced precision in movements. Additionally, it offers benefits such as reduced intraoperative bleeding, faster return to daily functions for patients, and decreased hospitalization duration. Consequently, the use of robots in various surgical procedures has become widespread in contemporary medical practice.

Robot-assisted laparoscopic radical prostatectomy is a surgical technique performed in a head-down Trendelenburg position with intraperitoneal insufflation of carbon dioxide (CO2). This positioning and pneumoperitoneum lead to an increase in intraabdominal pressure, as well as elevated intracranial and intraocular pressures.

End-tidal carbon dioxide (ETCO2) levels can vary during laparoscopic surgery. An increase in ETCO2 levels has been reported to cause an elevation in intracranial pressure, leading to an increased incidence of postoperative nausea and vomiting. Some studies in the literature have investigated the relationship between ETCO2 values and the incidence of postoperative nausea and vomiting in patients. Furthermore, it is believed that hypercarbia (elevated carbon dioxide levels) may have an impact on postoperative pain.

The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the ages of 18 and 80.
2. Patients with American Society of Anesthesiologists (ASA) scores I, II, or III.
3. Patients who have undergone robotic laparoscopic prostatectomy in the operating room.

Exclusion Criteria:

1. Patients under 18 years old or over 80 years old.
2. Patients with American Society of Anesthesiologists (ASA) scores IV and above.
3. Patients who refuse to participate in the study.
4. Patients undergoing emergency surgery.
Locomotor Training in Persons With Multiple Sclerosis

Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.

In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were suspended in a harness while in the Lokomat with full to partial body weight support as needed. After the training in the Lokomat, they practiced overground walking for 10 minutes.

The other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the Lokomat group for intensity, duration and frequency. they did not practice overground walking.

Primary outcome measure was speed to accomplish 25' timed walk.

Eligibility Criteria:
Inclusion Criteria:

* Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device

Exclusion Criteria:

* Ataxia
* Unable to ambulate
* Within 3 months of exacerbation
Effectiveness Study of an Exercise Program for Older Adults with Chronic Musculoskeletal Pain

The goal of this clinical trial is to evaluate the effectiveness of a multimodal physical exercise program for older adults (\> 60 years) with chronic musculoskeletal pain. The main question it aims to answer is:

What is the impact of the intervention program on participants´ pain intensity (primary outcome), function, physical performance, and somatosensory function (secondary outcomes)? Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (10 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program to be carried out over a period of 10 weeks at a frequency of twice a week.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults aged 60 years or older
* People with primary or secondary chronic musculoskeletal pain in any body site
* People able to walk independently

Exclusion Criteria:

* Individuals undergoing surgery in the last 3 months
* Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, stroke, uncontrolled diabetes, or at high risk of developing cardiovascular events
* Those with physical limitations that make it impossible for them to carry out the intervention protocols independently (e.g., wheelchair user)
* Patients who are receiving another physical therapy intervention to treat their pain.
Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.

Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.

Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character. About 10 to 25% of patients develop CF-related diabetes (DRFC), whose pathogenesis is associated with pancreatic fibrosis and destruction. Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase. Methods: Randomized clinical trial in patients with CF aged over 10 years without hospitalization in the last 4 weeks. Anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated. Oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up. The intervention group will receive a nutritional guidance at the beginning of the research.

Eligibility Criteria:
Inclusion Criteria:

* tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g of glucose between 140 and 199 mg / dl
* Stable pulmonary disease in the last four weeks

Exclusion Criteria:

* Without hospitalization in the last 3 months
Assessment of Family Planning and Immunization Service Integration in Liberia

This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities in Lofa and Grand Bassa counties in Liberia. MCSP used a longitudinal, pair-matched design to monitor the effect of integrating immunization and FP services on utilization of FP and routine immunization services. In Lofa and Grand Bassa counties, 36 facilities were pair-matched to intervention and comparison sites based on predetermined criteria. After approximately 9 months of implementation, MCSP conducted a qualitative study employing key informant interviews (KIIs) and focus group discussions (FGDs) at intervention and comparison sites, and with district-, county-, and national-level MOH supervisors and managers.


Eligibility Criteria:
Inclusion Criteria:

* 18 intervention facilities in Lofa and Grand Bassa counties
* 18 pair matched comparison facilities in Lofa and Grand Bassa counties

Exclusion Criteria:

* Facilities not included in the intervention or selected for pair matching
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers

Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433).

The primary purpose of each part is provided below:

* 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions
* 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily.
* An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions

The dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \[NCT02162199\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and/or contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has a history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results