cyrilzakka/clinical-trials huggingface dataset:
A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume

This is a prospective study to collect a nomogram of intra-abdominal volume correlated with height and weight for O\&G patients undergoing minimally invasive surgery.

This is a prospective study from the date of approval of the study for a period of 24 months.

The potential participants are from O\&G department who will be undergoing laparoscopy

The participant's height, weight, and total volume of carbon dioxide gas infused into the abdomen are collected from CPSS to create a standard operative pneumoperitoneum of 18mmHg for all patients undergoing laparoscopic procedures.

Patients with an abdomino-pelvic mass, or pelvic masses larger than 12 weeks size, or assessed to have an abdominal mass are excluded. Pregnant and/or breast feeding women are also excluded.

Specific patient identifiers will not be collected into the data collection and are not necessary to the study or to achieving to the objective of the study. Therefore data will not contain any identifiers.

Eligibility Criteria:
Inclusion Criteria:

* O\&G patients that are undergoing laparoscopic surgery.

Exclusion Criteria:

* Patients with an abdomino-pelvic mass
* Patients with pelvic masses larger than 12 weeks size
* Patients assessed to have an abdominal mass
* Pregnant and/or breast feeding women
Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

The primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
2. Nonsmokers
3. Periodontally healthy patients
4. Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth

Exclusion Criteria:

1. Medically compromised patients, especially uncontrolled diabetes
2. Pregnancy, lactation, or suspicion of pregnancy,
3. Poor oral hygiene
4. Recessions associated with caries or restoration
Probiotic Yoghurt Effect on Experimental Gingivitis

The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.

Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.

Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.

Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* No or minimal clinical signs of gingival inflammation
* Gingival Index ≤ 1
* No probing depth (Probing depth \> 3 mm)
* No approximal attachment loss \> 2 mm
* Non smokers

Exclusion Criteria:

* Systemic diseases
* Antibiotics and anti-inflammatory drugs within 3 months before the study
* Untreated caries lesions or local retention factors
* Mouth-breathing
* Allergies
* Previous probiotic supplements in diet
Molecular Breast Imaging in Women With Atypia and LCIS

We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.

Management of atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), and lobular carcinoma in situ (LCIS) diagnosed by breast needle core needle biopsy is controversial. Current practice is to recommend excisional biopsy to rule out malignant lesions, which have been reported in more than half of cases in some series. No consistent clinical, pathologic, or radiologic factors have been identified to select patients who do not require surgical excision. This is due, in part, to overlap in the mammographic features of benign and malignant lesions. Furthermore, reliance on mammography for surveillance of these high-risk patients is problematic. This highlights the need for a complementary imaging modality to improve the radiologic distinction between benign and malignant tumors and improve post-biopsy surveillance.

We are evaluating a new semiconductor-based gamma camera which we call Molecular Breast Imaging (MBI) which improves resolution by a factor of 2-3 compared to conventional gamma cameras, and, unlike mammography, is not affected by breast density. Preliminary clinical studies (IRB 0-1761-01)) have shown that scintimammography (SM) using Tc-99m sestamibi and the CZT camera (CZT-SM) has a high sensitivity and specificity for the evaluation of small (5-10 mm) lesions seen on mammography. We hypothesize that the MBI will reliably distinguish lesions that require excisional biopsy from lesions that do not. A secondary aim is to compare the role of MBI with mammography in post-biopsy surveillance.

We aim to enroll 50 Mayo patients who have received a diagnosis of ADH, ALH, or LCIS on core biopsy, who have not yet undergone excisional biopsy, and who consent to undergo MBI of both breasts. For images in which there is discordance with mammographic findings, ultrasound will be used to determine if additional abnormalities warrant excision. Using pathologic correlation, we will determine: 1) If residual foci of ADH, ALH, and LCIS are visible on MBI images; and 2) If MBI images can reliably predict contiguous or separate foci of malignant lesions in either breast.

Eligibility Criteria:
Inclusion Criteria for Surveillance Arm:

* Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist.

Inclusion Criteria for Diagnostic Arm:

* Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist.

Exclusion Criteria:

* They are unable to understand and sign the consent form
* They are pregnant or lactating
* They are physically unable to sit upright and still for 40 minutes
* They are younger than 18 years of age.
Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties

Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A and then to the group B.

Background: Cognitive remedial interventions have been found to be effective in the treatment of various psycho-social disorders. The use of Virtual reality as a rehabilitation tool has been showing various scientific evidences in recent years like in cardiovascular, neurological and musculoskeletal rehabilitation. In mental health evidence they seem to be concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis and psychotherapy. The aim of this study is to evaluate the feasibility and the effectiveness of the first Cognitive Remedial toll in Virtual Reality (CEREBRUM) for people that has experienced in mental health.

Methods: Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a intervention of 3 months with 2 weekly session of CEREBRUM first to the group A and then to the group B

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75;
* Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
* both sexes;
* users who sign the informed consent;
* users under protection for which the informed consent is signed by the guardian

Exclusion Criteria:

* The non-satisfaction of the inclusion criteria;
* The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality
Sarcopenia and Cachexia in Patients with Lung Cancer

The PHILICA study investigates whether muscle mass, muscle strength, and muscle function are associated with treatment tolerance, quality of life and survival in patients with lung cancer. It also aims to explore why some patients face challenges in completing their treatment. The findings may contribute to improved strategies for supporting patients and developing more precise and individualized treatment plans in the future.

The PHILUCA prospective cohort study investigates the relationship between sarcopenia, cachexia, and change in muscle parameters with both treatment tolerance, quality of life and survival in patients with lung cancer (n=180). It aims to identify factors associated with difficulties in completing oncological treatment and to elucidate patterns that may inform improved patient support and individualized treatment planning. The study involves non-invasive physical assessments, patient-reported questionnaires, and the analysis of routinely collected medical data.

Assessments of muscle mass, muscle strength, muscle function, and quality of life are conducted at key time points, including at diagnosis, three months, and six months into treatment. For patients undergoing chemotherapy, muscle strength- and function tests are - in addition to the planned assessments - also performed before each treatment cycle, but no later than six months after the diagnosis. Physical tests are performed during routine hospital visits, requiring no additional appointments. Body composition analysis is performed using Computed Tomography scans obtained as part of standard care, without additional imaging procedures.

All participants receive standard lung cancer treatment, which may include surgery, chemotherapy, radiation therapy, immunotherapy, targeted therapy, or combinations thereof, based on disease type and stage. The study does not interfere with or modify standard care protocols. Participants unwilling or unable to fully participate may still contribute by completing a baseline questionnaire and consenting to the use of medical record data.

The study seeks to advance the understanding of how muscle-related parameters influence cancer treatment outcomes. The findings are anticipated to inform strategies for optimizing treatment tolerance, improving patient outcomes, and tailoring supportive care interventions for individuals with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Diagnosed with lung cancer (all types and stages) and scheduled for oncological treatment
* More than 3 months expected survival

Exclusion Criteria:

* Competing cancer
* Pregnancy
* Severe physical or cognitive disabilities preventing physical testing and informend consent
* Not able to read and understand Danish
TASALL - TachoSil® Against Liquor Leak

The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.


Eligibility Criteria:
Main Inclusion Criteria (Positive response):

• Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following:

* Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral
* Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular
* Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid
* Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition)
* Approach to the anterior fossa: Subfrontal (uni or bilateral)
* Approach to the midline posterior fossa

Main Exclusion Criteria (Negative response):

* Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months?
* Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week?
* Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks?
* The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:

  * Trans basal approach
  * Total petrosectomy
  * Trans facial approach
  * Trans sphenoidal approach
  * Endoscopic procedures
  * Trans oral approach (and any extension: Le Fort, mandibulotomy)
* The surgical approach is consistent with one of the following approaches?

  * Translabyrinthine approach
  * Retrolabyrinthine approach
  * Transcochlear (limited transpetrosal) approach
* Did the arachnoid membrane and the CSF containing system remain intact during surgery?
* Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?
* Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of moderate to severe rheumatoid arthritis.
* On stable dose of methotrexate.
* 18 to 80 years of age.
* Less than 275 lbs.

Exclusion criteria:

* Joint replacement surgery within 60 days of the start of drug dosing.
* Intra-articular cortisone injections within 28 days of the start of drug dosing.
* Pregnancy.
* History of severe allergic or anaphylactic reactions.
* Active bacterial, viral, fungal, mycobacterium tuberculosis.
* Positive PPD test.
* History of any opportunistic infection.
* Serious persisting local or systemic infection.
* History of malignancy within the past five years.
* Received any vaccine within 28 days of the start of study drug dosing.
* Joint replacement therapy planned within nine months of the start of study drug dosing.
* Chronic disorders apart from RA affecting the joints.
* Significant systemic involvement secondary to RA.
* COPD, asthma, or other pulmonary disease.
* Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing.
* Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing.
* Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing.
* Liver disease or abnormal hepatic function.
* Serum creatinine level \> 1.5 mg/dL.
* Platelet count \< 125,000 cells/mm3.
* WBC count \< 3,500 cells/mm3.
* Seropositive for hepatitis B surface antigen.
* Seropositive for hepatitis C antibody.
* Known seropositivity for HIV.
Comparing Infectious Morbidity Among Women with Meconium-stained Amniotic Fluid At Term, Between Those Treated with Prophylactic Antibiotics Zinacef Vs. Placebo

Our randomized controlled double blind clinical trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo.

The relationship between meconium staining and chorioamnionitis, as well as neonatal sepsis, has been documented, yet the precise mechanisms remain unclear. Additionally, the correlation between prolonged labor and meconium staining was described in the past. In light of these findings, our randomized controlled double blind trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo. Additionally, we aimed to assess the distribution of pathogens in chorioamnionitic swab cultures relative to the antibiotic treatment

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy at term
* meconium-stained amniotic fluid

Exclusion Criteria:

* Intrauterine fetal death
* GBS carriers
* zinacef allergy
* antibiotic treatment for other indication
The Effects of Subgingival Air-polishing, as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Parameters and Patient Satisfaction in Patients With Periodontitis

Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.

Several studies reported the additional benefits provided by the use of air-polishing devices in combination with ultrasonic debridement in the treatment of gum disease, their use may reduce postoperative pain and discomfort while providing improvement in gum status.

The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined air-polishing and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).

Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland). Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over.
* Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.
* Good compliance and commitment to attend follow-up review appointments.
* Absence of systemic disease that will may affect the treatment outcome.
* Willing to provide informed consent.

Exclusion Criteria:

* Received periodontal treatment in the last 12 months.
* Received systemic anti-inflammatory or antibiotic in the last 6 months or during the study period.
* Use of medication known to affect the gingival growth.
* Chronic bronchitis.
* Asthma.
* Participants that require prophylactic antibiotic.
* Pregnant or breastfeeding participants
Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.

All the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation or control group with conventional pharyngeal anesthesia without further treatment. And the investigators compared their baseline characteristics, past history, sedation or not, and frequency of retching and belching were measured during the endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room, Cheju Hall General Hospital.

Exclusion Criteria:

* advanced older or younger age (\> 90, or \< 15 years)
* comorbidities scored greater than III of American Society of Anestheiologists Physical Status Classification System (ASA) score
* history of hypersensitivity reaction to lidocaine
* he pregnant
* therapeutic or emergency endoscopy
A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)

The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
* Has a body mass index (BMI) 18.0 to 32.0 kg/m\^2 (inclusive)

Exclusion Criteria:

* Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
* Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)