cyrilzakka/clinical-trials huggingface dataset:
Structural Changes of Subcutaneous Tissue by Ultrasonographies in Patients After Treatment With PnKCelulitis® Program

Exploratory, prospective, uncontrolled and single-blinded pilot study, with clinical and ultrasound assessments of cutaneous cellulite before and after treatment with a specific multidisciplinary programme following dietary guidelines, physical exercise and the application of a cosmetic cream.

Females older than 18, with normal weight ranges in addition to the presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy), were recruited for the study and to undergo treatment with the multidisciplinary programme.

All patients were treated with the specific multidisciplinary programme for cellulite (PnKCelulitis®). This programme consists of three phases or processes: the restructuring, drainage and toning processes, each of which combines diet, physical exercise and the application of an anti-cellulite cream that combines active lipolytic and vasodilator agents (Cellulite Gel K-Line®).

Patient's clinical assessment follow-up was performed by the prescribing doctor for the multidisciplinary treatment and was done in four visits: baseline (before starting treatment) and at the end of each of the phases (restructuring, drainage and toning). Anthropometric data were recorded at each visit and a bioelectric impedance test to assess body composition (amount of fat mass and muscle mass). The clinical evaluation of the degree of cellulite was made according to the Nürnberger-Muller classification scale.

Cutaneous ultrasound was performed by an expert dermatologist in the dermatology outpatient clinic of the hospital and subsequently assessed blinded. Two skin scans were done for each patient, one before starting the treatment and another at the end. The objective data collected on each ultrasound were total skin thickness, thickness of the dermis and hipodermis, the area of the indentations of the subcutaneous cellular tissue in the dermis and changes in the echogenicity of the dermis blinded and independently assessed by two researchers, comparing ultrasounds before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Females older than 18 years
* Normal weight ranges
* Presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy)
* Women who are going to begin treatment with the multidisciplinary programme

Exclusion Criteria:

* Pregnant or lactating females
* Contraindications of a ketogenic diet
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. Patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.

After the initial 2 hours in the research center, patients were discharged with an outpatient diary to continue (while awake) to document hourly assessments of Sore Throat Pain Intensity Scale (STPIS), Difficulty Swallowing Scale (DSS), and Swollen Throat Scale (SwoTS) through 24 hours. They used the assigned lozenges as needed every 3-6 hours, up to 5 lozenges over 24 hours. A Follow-Up Visit was conducted for the 24-hour assessments.

Patients received additional study lozenges for use as needed (up to 5 lozenges per 24 hours) over the following 6 days, rescue medication (acetaminophen 650 mg) and a Diary to document their safety and efficacy assessments immediately before and postdose after each as-needed use of a lozenge for the remaining days in the 7-day treatment period. At the end of the 7-day trial, patients returned to the research center for final assessments, review of adverse events over the week, and discharge from the study.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has a complaint of sore throat.
2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.
3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
4. The patient has provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).
2. The patient has a history of any hepatic disease or renal dysfunction.
3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)
Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer

A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA (BReast CAncer gene) 1/2 Mutation

A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
2. Female Subjects with ≥ 18 years of age
3. Subjects receiving olaparib for the following indications in ovarian cancer:

   for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
4. Subjects receiving olaparib for the following indication in breast cancer:

in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment

Exclusion Criteria:

1. Patients with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
2. pregnant and/or lactating women.
3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis.
4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment.
5. Patients who have known history of hepatitis B or hepatitis C
6. Patients with active infection such as TB.
7. Participation in another clinical study with a study drug administered in the last 3 months
Lung Ultrasonography in COVID-19 Pneumonia

Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.

In this study, it was aimed to investigate the efficiency of lung ultrasonography in diagnosis of covid 19 pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 85 years old
* Hospitalized in intensive care unit
* PCR tested
* Thoracic CT applied

Exclusion Criteria:

* Previous lung and thoracic wall surgery
* Anatomically with thoracic wall disorder
* Patients who did not consent to participate in the study
Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study

This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.

OUTLINE:

Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after completion of curative therapy for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* People with prostates ≥40 years of age
* Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.

Exclusion Criteria:

* Prior diagnosis of prostate cancer
* Medical contraindication to any of the study procedures (e.g., prostate biopsy)
* For all cancer types except non-melanoma skin cancer, any cancer treatment with curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy, immunotherapy)
* Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk
* Unable to provide written informed consent
* Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol.
Pelvic and Acetabular Fracture in Old People

It was reported that satisfactory postoperative outcome was difficult to obtain for the pelvic or acetabular fracture in old people. The less invasive surgical method was conducted in this study. Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.

Pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor prognosis for the old. The patients over 60 years were included in this study. The surgical procedure was conducted in two weeks. The less invasive methods involved Stoppa approach and novel plate. The data including surgical time, blood loss and results of follow-up were recorded. The clinical results were compared with the patients treated using traditional methods. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.

Eligibility Criteria:
Inclusion Criteria:

Over 60 years old Fracture involving pelvis or acetabulum Operation was conducted within 14 days Sign the consent form

Exclusion Criteria:

Presented with a pathologic acetabular fracture Refused to participate Follow-up insufficient 12 months
Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects

This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 to ≤55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Able and willing to provide written informed consent
* Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Able to tolerate prolonged periods of quiet, motionless, supervised rest

Exclusion Criteria:

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days prior to Screening
* Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
* Prior exposure to LX4211
* Daily use of cigarettes or any tobacco products within 3 months prior to Screening and while participating in the study
* History of any major surgery within 6 months prior to Screening
* History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* Women who are breastfeeding or are planning to become pregnant during the study
* History of any active infection within 14 days prior to Screening
* History of alcohol or substance abuse within 2 years prior to Screening
* History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
* Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF \>450 msec for females and QTcF \>430 msec for males) at Screening
* \>30 premature ventricular beats per hour on the telemetry ECG monitoring at Day -2 of Period 1
* History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
* Any skin condition likely to interfere with ECG electrode placement or adhesion
* Any skin condition likely to interfere with ECG electrode placement or adhesion
* Donation or loss of \>400 mL of blood or blood product within 3 months prior to Screening
* Positive urine glucose during Screening
* Positive pregnancy test during Screening
* Positive urine screen for drugs of abuse during Screening
* Positive urine test for alcohol during Screening
* Inability or difficulty swallowing whole tablets or capsules
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla

In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.

Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest.

The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits:

1. Reduced mechanical stress at the implant neck area;
2. Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition);
3. proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space.

The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues

Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene
* Systemically healthy (free from any systemic diseases).
* Adequate native bone to achieve implant primary stability
* Have had the tooth extraction at least 3 months before implant surgery.
* Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery

Exclusion Criteria:

* Smokers
* Pregnant woman
* Had a history of alcoholism or drug abuse within the past 5 years.
* Had bruxism or clenching habits.
* Patients who refused to join the study.
* Had significant untreated periodontal disease or history of treated periodontitis.
* Had caries on teeth adjacent to the prospective implant site.
* Periapical infection.
* localized radiation therapy of the oral cavity; antitumor chemotherapy.
* poor oral hygiene
Probiotic Supplementation on Sport Performance and Gut Damage in Females

This study will be performed with the aim to evaluate the effects of probiotic supplementation on sport performance and gut damage. Participants will be divided into two groups, placebo and experimental group. With the purpose to assess the effects of probiotics on the gut damage, a strenuous exercise session will be performed, and then blood samples will be taken to observe the variation of the selected intestinal damage marker. 24 hours after this strenuous session, performance tests will be performed. After the 4 weeks of supplementation, the same procedure will be followed to evaluate the effect of probiotics.

One week before the initiation of the study participants will be required to avoid consuming drugs, alcohol, cigarettes, probiotics, and any other food or liquid which could modify gut microbiota composition. For the baseline values, height, weight and sports performance test, of the participants will be collected. The same day, a strenuous exercise session will be performed in order to observe the variation of the intestinal damage marker (blood sample extraction just after finishing the strenous exercise session). 24 hours after that session sport performance tests will be conducted. Participants will then be randomly divided into two groups, one of which will take one probiotic capsule per day containing 10 billion colony-forming units (CFU) of Lactobacillus plantarum, and the other group will take one placebo capsule per day consisting of dextrose. The supplementation period will last 4 weeks.

After the supplementation period, the same process will be followed, with the same strenuous exercise session and immediate blood sampling to determine the effects of probiotics on the intestinal damage caused by exercise. 24 hours later, performance tests will be conducted to assess the effects of probiotics on sport performance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No injuries
* 1 year of CrossFit practicing experience

Exclusion Criteria:

* Drug, alcohol, cigarettes, probiotic intake
* Injuries
Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)

The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.

We will perform a proof-of-concept study according to a prospective randomized open label blinded endpoint (PROBE) design. Patients with an acute myocardial infarction (AMI) and their healthy life partners / spouses will be randomly assigned to an immediate vegetarian diet or their habitual diet. Patients with AMI will be stratified for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI). The dietary intervention will start one week after the index event and will comprise a period of five weeks. After a stabilisation phase (six weeks), to assure normalisation of the inflammatory response secondary to the acute myocardial infarction, patients and their spouses will follow the other dietary intervention arm. Then, half of them will start directly with the other dietary intervention and half of them will start after a period of five weeks. Blood samples will be taken at the time points. Also, all participants will be asked to complete a questionnaire at baseline, after twelve weeks and at nine months follow-up. Infarct size as assessed by Cardiovascular Magnetic Resonance (CMR) imaging will be used to adjust cytokine levels.

Eligibility Criteria:
Inclusion Criteria for patients:

* Acute myocardial infarction (STEMI/NSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \<1 week before randomisation
* Body mass index between 18.5 and 35 kg/m2
* Written informed consent

Inclusion Criteria for healthy volunteers (life partners / souses)

* Body mass index between 18.5 and 35 kg/m2
* Written informed consent

Exclusion Criteria for patients and healthy volunteers:

* Already on a vegetarian or vegan diet
* Previous myocardial infarction
* Diabetes Mellitus
* Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)
* Use of immunomodulatory drugs
* Vaccination less than one month before start of intervention
* Clinically significant infections within 1 months prior to start of intervention (defined as fever \>38.5 degrees Celsius)
* Active malignant haematological disease
* Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)

Exclusion Criteria for healthy volunteers

- Use of lipid lowering therapy