cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Patients With Chronic Liver Disease

TARGET-Liver Disease (TARGET-LD) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (CLD).


Eligibility Criteria:
Inclusion Criteria:

Disease Cohort

•Adult\* patients at the time of enrollment with a diagnosis of CLD/cirrhosis by ICD-10 code in the EHR interface

Engaged Cohort

* Adult\* patients diagnosed and managed for CLD/cirrhosis invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

Disease Cohort

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years.

Engaged Cohort

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.
A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
* Measurable disease at screening as defined per protocol.
* Has received at least 2 prior lines of therapy as described in the protocol.
* Has had documented disease progression on or within 60 days after completion of the last therapy.
* Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
* Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
* Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
* An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.

Exclusion Criteria:

* History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
* History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
* Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
* Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
* Known central nervous system involvement of MM.
* Concurrent conditions as listed in the protocol.
AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS

Aim of the study is to evaluate the prevalence and bring awareness ofcardiovascular complications in COVID-19 recovered patients. Study is conducted at single site, which is Srinivasa Heart Centre, Warangal, Telangana state in India for the duration of 4 months. The sample size is calculated 500 patients and the study is cohort, observational study. Patient consent has been taken before enrolment.

The aim of the study is to evaluate the prevalence and bring awareness of cardiovascular complications in COVID-19 recovered patients.

Objectives of the study:

1. To study causes and risk factors of cardiac disorders associated with COVID-19
2. To identify different types of cardiac symptoms patients, present with
3. To study the impact of co-morbidities on COVID-19 recovered patients
4. To study treatment patterns and duration of therapy

Plan to study:

* To select the patient based on inclusion and exclusion criteria
* To collect the patient information from case sheets and by patient interaction
* To identify different types of cardiac disorders related to COVID-19 or its treatment regimen
* To study the management of COVID-19 complication and related cardiovascular disorders

Study Sites: Srinivasa Heart Centre, Warangal (T.S) Study Design: Observational cohort study Study Duration: 4 months

Subject Eligibility:

1. Inclusion Criteria

   * Patients who are willing to participate
   * Patients having previous COVID-19 treatment record
   * Prescriptions reported during the study period
   * The prescription which is legible and complete
2. Exclusion Criteria

   * Patients who are not willing to participate
   * The patient having no history of COVID-19 and available data

Source of the data:

1. Review of patient case sheet, prescription and lab reports
2. Personal interaction with patients and caregivers

Sample size: 500 Patients

Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing to participate
* Patients having previous COVID-19 treatment record
* Prescriptions reported during the study period
* The prescription which is legible and complete

Exclusion Criteria:

* Patients who are not willing to participate
* The patient having no history of COVID-19 and available data
Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material

This double blind randomized controlled prospective clinical trial will compare the clinical success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk) and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the posterior restorations for 24 months in duration

The purposes of this clinical trial is to evaluate two composite resins used to restore Class I and Class II cavities in teeth of adults. The clinical study will evaluate the resin composite restorations placed in Class I and Class II cavity preparations for anatomic form, color match, marginal integrity, marginal discoloration, proximal contact, polishability, caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..

Eligibility Criteria:
Inclusion Criteria:• must have given written consent to participate in the trial

* must be in need of at least two restorations in natural tooth
* replacement restorations with or without caries are acceptable
* must be available for the required post-operative follow-up visits
* restorations to be in bicuspids, 1st or 2nd molars
* restorations to be in contact with opposing natural or crowned teeth
* class II restorations must have at least one proximal contact
* restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* 75% of the restorations must be Class II
* all restorations must have at least one occlusal contact in habitual closure

Exclusion Criteria:

* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) or disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
* have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
* have a history of chronic bruxism and those unavailable for long term recall
* can not tolerate the rubber dam required for tooth isolation during preparation and restoration.
* do not meet all inclusion criteria
* present with any systemic or local disorders that contra-indicate the dental procedures included in this study
* have an unstable occlusion
* have severe bruxing or clenching or need of TMJ related therapy
* have teeth with periapical pathology or expected pulp exposures
* have teeth that are non-vital or that exhibit signs of pulpal pathology
* Pregnancy
* Known sensitivity to methacrylates and/or acrylates
Immediate Breast Reconstruction With Acellular Dermal Matrix

The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
* Mastectomy weight ≤ 600 g
* Patient older than 18 years
* Ability to complete the study questionnaire
* Only for the two-stage group no later than 2 years and 4 months from breast reconstruction

Exclusion Criteria:

- smokers
The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study

Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to be in the range of 5-30%, but limited number of long-term follow-up results.

Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.

Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees in Korea at 2001.

Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched, non-infected 105 contemporary hospital employees.

Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after outbreak.

Postinfectious-IBS (PI-IBS) can be defined as the acute onset of new IBS symptoms in an individual, who has not previously met the criteria for IBS, immediately following an acute illness characterized by 2 or more of the following: fever, vomiting, diarrhea, or a positive bacterial stool culture.

Our group previously have reported clinical course of PI-IBS in a homogenous cohort which was comprised of patients recovered from Shigellosis. And in current study, we finally report a collective result of 10-year long-term follow-up of our small, but well-followed, homogenous cohort of PI-IBS after Shigellosis.

Eligibility Criteria:
Inclusion Criteria:

* Shigella sonnei infected patients

Exclusion Criteria:

* refused to participate in these surveys
* pregnant or had history of abdominal surgery or chronic organic gastrointestinal disorder
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects over 18 years;
2. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
3. Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

Exclusion Criteria:

1. Subjects with evidence of disease or major surgery;
2. History of drug allergy;
3. Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
4. Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
5. Those who have heavy smokers, alcoholics or drug abuse
6. Lactating female subjects or fertile female subjects
7. Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics

The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.

The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders.

Employing within-subject pre-post design to assess 1) patterns of aggregate risk data from video analysis in the OR for resident and attending surgeons over time and for different types of surgical tasks, 2) concurrent reliability assessment of the Rapid Upper Limb Assessment and Rapid Entire Body Assessment scores calculated from the software and visual analysis, 3) changes in pain data after review of the SOTER Task ergonomic outputs. The feasibility of using the system in the OR will also be assessed for open and laparoscopic surgery.

The study team will collect data, perform assessments, collect information from self-proctored surveys, and video record surgeon activities in the operating room on 20 surgeons. The video recordings will take measurements to assess risk factors for work-related musculoskeletal disorders. Following the fifth surgical case, the study team complete an education intervention by reviewing measurements established in the video recordings and supply a brief presentation on Ergonomics for Surgeons. A summary of observed body positioning for each subject is provided. Post intervention, five additional surgical cases will be observed in the manner of the previous cases to identify change in ergonomic risk.

Eligibility Criteria:
Inclusion Criteria:

• Any general surgery operative case by a surgeon from the Division of Acute Care Surgery. These cases will be conducted in what has been designated as the "Acute Care Surgery OR" for the day.

Exclusion Criteria:

* Any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case.
* Any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome

The main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to:

1. Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
2. time to prepare a set of body marker in order to execute a gait analysis;
3. walking activity over treadmill, with immersive virtual reality;
4. proprioceptive stimulatione provided by the GRAIL platform;
5. cognitive-attentive span time to the activity proposed. The secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by Rett syndrome


Eligibility Criteria:
Inclusion Criteria:

* subjects affected by Rett Syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of Rett Syndrome Gross Motor Scale)

Exclusion Criteria:

* subjects unable to walk and with a complete incapacity to undestand verbal directions
The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES).

Background: Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES).

Methods: This is a split-mouth and controlled study. Thirthy-eight Class I or II gingival recession defects at canine teeth were treated in the control (SCTG) (n=19) and test groups (n=19) (SCTG+EMD). The root coverage esthetic score were evaluated by 2 blind periodontists 1 year after the treatment using RES. The agreement between the two periodontists was assessed by kappa analysis. Complete root coverage rate was evaluated for both groups. Two groups were compared with statistically methods in terms of RES parameters and gingival recession height /width.

Eligibility Criteria:
Inclusion Criteria:

* The patient had no systemic disease, did not smoke cigarette and tobacco products, did not have a pregnancy and breastfeeding period, had class I and class II gingival recession according to the Miller gingival classification, had a recession depth of ≥2 mm, have not had a restoration and have had an operation in the relevant dental region that had no previous gingival surgical procedure were included in this study.

Exclusion Criteria:

* systemic disease
* multiple gingival recession
* miller class III and IV recessions were excluded
Cortical Bone Trajectory With Patient Guide

The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.

This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer

Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.

After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up

Eligibility Criteria:
Inclusion Criteria:

1. those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
2. those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
3. those who signed consent form to participate to the study
4. Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
5. Patients with BMI ≤ 35 kg/m2
6. non responsive or unsufficient resposive to non -invasive treatment such as analgesics

Exclusion Criteria:

1. Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
2. Patients \<18 years
3. Patient who is pregnant or intends to become pregnant during the study
4. Known substance or alcohol abuse
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.

Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.

Eligibility Criteria:
Inclusion Criteria:

* Males and postmenopausal females at least 40 year old
* BMI ≥25 and \<40 kg/m2
* Waist circumference ≥ 102 cm for men, ≥88cm for women
* CANRISK score ≥21 which indicates an elevated risk for type 2 diabetes

Exclusion Criteria:

* Diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L)
* Restrained eating habits
* Gastrointestinal conditions (Celiac's disease, Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease)
* Renal Conditions
* Hepatic Conditions
* Surgery or major medical event within 3 months of study start date
* Select medication use (Glycemia medications, cholesterol-lowering agents, antibiotics within 6 months of the study, other medications known to influence blood glucose insulin, cholesterol, triglycerides, incretin hormones of the digestive tract microbiome)
* Select natural health product (NHP) use (Phytosterols or phytosterol functional foods, other NHPs intended for glycemic or cholesterol control)
* Gluten allergy or intolerance
* Alcohol consumption \>15 drinks/week for men and \>10 drinks/week for women
* Significant international travel within 6 months of the starting the study, or plans to travel internationally during the study.