cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

Ideal bone graft should possess osteogenic, osteoinductive, and osteoconductive properties. Unfortunately, all of these are solely found within the autogenous graft that is available only in limited quantities, and it is associated with substantial post-surgical morbidity, However in this study Silica-calcium phosphate composite (SCPC) confirmed clinically, radiographically, histomorphometricand immunohistochemically the vitality and functionality of the newly formed bone. Histology and immunohistochemistry demonstrated maturation of the newly formed bone as indicated by presence of osteocytes, Haversian systems, blood vessels, compact mineralized collagen type I and high immune staining for osteopontin.

Alveolar ridge resorption following teeth extraction leads to 50% loss in bone width over one year period which corresponds to 5 -7 mm mainly from the buccal rather than palatal\\lingual aspects. Several calcium phosphates from bovine and synthetics sources are used for preservation of extraction socket; however with variable degrees of success. The aim of the present study is to evaluate clinically, radiographically and histologically the effect of Silica-calcium phosphate composite (SCPC) granules on new bone formation qualitatively and quantitatively following socket augmentation. This case series study was performed in five (n = 5) participants (one male and four females), all participants underwent socket augmentation procedures and dental implant placement in a staged approach. All participants were fully informed about the procedures, including the surgery, bone substitute materials and implants. Each participant had one extraction socket to be grafted with silica-calcium phosphate SCPC dental bone graft granules and the contralateral socket served as ungrafted control. Clinical, radiographic and histological evaluation was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients require extraction of bilateral non-restorable (premolar or anterior) tooth located in the maxillary arch and need implant restoration.
* Teeth to be extracted are free from acute periapical infection or active periodontitis.
* Buccal plate of bone is intact
* Systemic free patients
* Patients were able to swallow tablets.

Exclusion Criteria:

* Patients with remaining root accompanied with acute periapical infection or sinus tract
* Insulin dependent diabetes patients.
* Thyroid disease patients.
* Smoker´s patients
* Patients with compromised health (ASA (III or IV) - according to the classification of American Society of Anaesthesiology including drug or alcohol abuse or any significant systemic disease.
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects

JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection.

Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30 participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive investigational product or placebo treatment, respectively.

"Each participant will receive JS016 or matched placebo intravenous infusion on D1 (randomizing day). Non-pharmaceutical supportive background therapy (e.g. oxygen inhalation) for COVID-19 is allowed per clinical needs.

Investigators will be kept blinded to review the preliminary efficacy and safety data on a regular basis. Meanwhile, a study evaluation team (SET) composed of medical monitors, safety assessors and statisticians will be set up to review the study status, safety and preliminary efficacy of the participants at the pre-specified time points or as necessary.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-65 years (inclusive) ,women or man
2. SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab)
3. High homology of viral gene sequencing with the known SARS-CoV-2."
4. Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection
5. Within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of SARS-CoV-2 positive test to randomization with required viral load
6. No plan of pregnancy and being willing to use effective contraceptive measures
7. Signed the informed consent form, sufficiently understanding of the content

Exclusion Criteria:

1. positive IgM/IgG against SARS-CoV-2 prior to randomization.
2. Severeor critical illness
3. Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases
4. Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes
5. Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases
6. History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-2.
7. Use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing
8. Has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing
9. Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc.
10. Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others
Acid-Base Compensation in Chronic Kidney Disease

The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. This may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. Participants with and without kidney disease will be recruited. Each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. The investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* estimated glomerular filtration rate ≥30 ml/min/1.73m2
* serum bicarbonate 20-28 mEq/L

Exclusion Criteria:

* diabetes mellitus
* uncontrolled hypertension or recent (\<3 weeks) titration of blood pressure medications
* clinically significant volume overload on screening physical examination
* selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)
* use of alkali supplementation
* body mass index \<18.5 or \>40 kg/m2
* ideal body weight \<45.5 kg
* anemia at screening (hematocrit \<29% in participants with kidney disease or \<33% in healthy participants)
* pregnancy or breastfeeding
* allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu
* serum calcium less than 8.6 mg/dl on screening laboratories
Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.

Therefore, we should explore the most appropriate lung protection ventilation strategy to reduce the occurrence of pulmonary complications. The recommended standard of international expert group on lung protective ventilation strategy points out that the lowest concentration of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it may reduce the postoperative pulmonary complications of the subjects. However, there are few reports on the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer. This study intends to explore the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* American Association of Anesthesiologists (ASA) patients with I-II physical condition;
* Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position.

Exclusion Criteria:

* there is a history of acute lung injury with acute respiratory distress syndrome within three months;
* Heart failure (classified by new york Heart Association) is greater than grade IV,
* there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate \< 30 ml/min);
* Body mass index \> 30kg/m2；
* coagulation dysfunction;
* Operation time exceeds 10h
* The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.
Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs

This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.

The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aging from 18 to 70
* 40-60% women, 40-60% men
* Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth
* Patients who are not allergic or sensitive to the ingredients contained in the products
* The test patient consents to the restorative treatment in line with the study´s criteria (informed consent)
* Sufficiently understanding of the language

Exclusion Criteria:

* Extremely low level of oral hygiene
* Teeth with previous restorations
* Not possible adequate isolation of the operating area
* Patients with serious systemic diseases
* Devitalized teeth or with pulpitis in progress
* Periodontal problems on the elements to be restored
Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study

Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain relief, will be rotated to Methadone. We will try to find out what is the best methode to rotate, and the equivalent dosage.

This study is based on the clinical observation that patients who are not well controlled on morphine or oxycodone may benefit from switching to another opioid, in this case methadone. Although the mechanism for such switch is not completely understood, evidence indicates that opioids with different chemical structures have different characteristics, not least in relation to new knowledge about genetic variation in opioid receptors. Another challenge is that there is much uncertainty regarding equianalgesic dose ratios for morphine and methadone. It seems that the higher the morphine doses, the relatively lower methadone doses are needed to substitute morphine. Furthermore, there is uncertainty to which switching procedures one should use, the most common ones are "stop and go" and a three days switch. Finally, it is reported that methadone may increase the QT interval of the ECG, and thus increase the risk for the ventricular arrhythmia Torsade de pointe. The aim of this randomized, open label, multicenter study is primarily to compare the switching procedures, but it will also provide more knowledge about equianalgesic dose ratios, the effect of methadone on the QT interval, genetical factors that may characterize patients needing opioid switch as well as their response to it, and finally if pharmacokinetic factors plays a role.

Eligibility Criteria:
Inclusion Criteria:

* • Malignant disease.

  * On morphine and in need of opioid rotation. (A patient in need of opioid rotation is defined as having insufficient pain control with or without unacceptable side effects from opioids).
  * Able to complete the planned assessment schedules.
  * Above 18 years of age.
  * If out-patient, the patient lives with someone who can observe him/her.
  * Given informed consent according to the ethical guidelines.

Exclusion Criteria:

* Not able to read or write in Norwegian
* The patient has participated in a clinical study 4 weeks prior to inclusion
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance
* On diet/exercise therapy
* Unlikely to conceive
* Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) \<6.1%, Fasting Plasma Glucose \<126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and \<200 mg/dL

Exclusion Criteria:

* History of diabetes mellitus
* Disease or condition of clear or likely glucose tolerance disorder
* Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug
Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or documented infection
* Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
* Serum lactate levels \>2 mmol/L
* Norepinephrine infusion of \> 0.2 mcg/kg/min

Exclusion Criteria:

* Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
* Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
* Lithium treatment
* Treatment with other vasopressor or inotropic drugs.
Name Generator Order Effects in Social Networks

The objective of our study was to determine the extent to which the order of specific items in a multiple name generator survey affects how social networks are measured.

Interpersonal relationships are one feature of the social environment that have been shown to have important influences on health and health behaviors (Berkman et al., 2000; Berkman \& Syme, 1979) and mental health (Tsai et al., 2014). While the majority of these studies have been conducted in resource-rich settings, studies conducted in resource-limited settings have similarly demonstrated associations between social networks and health (Perkins, Subramanian, \& Christakis, 2014). In this literature, the tie between two persons is the important unit of measurement. Classically, the social tie is typically elicited using a "name generator" survey that inquires about ties based on the affective content of the relationship (Laumann, 1966; Wellman, 1979) or normative bonds such as kinship ties (Kleiner \& Parker, 1976).

Another popular approach to eliciting social ties has employed multiple name generators inquiring about specific types of interactions, such as discussions about important matters or exchanges of money (Burt, 1984; Marsden, 1987; McCallister \& Fischer, 1978). These types of name generators have strong face validity, are less likely to be subjectively interpreted in different ways by different respondents, and are therefore likely to be more reliable. These are accompanied by a heavy respondent burden, however, and single-item name generators may perform comparably to multiple name generators only under limited circumstances (Marin \& Hampton, 2007). It remains unclear, however, whether the order of name generators may affect study participant responses. While no studies have examined this empirically, there is a broad literature on public opinion polling suggesting that alternative specifications of question ordering can have important effects on respondents' answers (McFarland, 1981).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Emancipated minors aged 16-18 years
* Considers Nyakabare Parish their primary place of residence
* Capable of providing informed consent

Exclusion Criteria:

* Minors younger than 18 years, with the exception of emancipated minors
* Does not consider Nyakabare Parish their primary place of residence
* Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia
* Persons with psychosis, neurological damage, acute intoxication, or an intelligence quotient less than 70, as determined in the field by non-clinical research staff in consultation with a supervisor
RGD-K5 in Head and Neck Cancer Patients

1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
2. Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients (including nasopharyngeal cancer)
* Age equals or more than 20 years old
* Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
* Willing to sign the informed consent

Exclusion Criteria:

* Patient who is pregnant or lactating;
* Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
* Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
* Unable to give informed consent
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
2. Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology

Exclusion Criteria:

1. Patients requiring stoma formation as part of the operative procedure
2. Patients undergoing loop ileostomy or colostomy closure thru the stomal site
3. Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values)
4. Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification \>2
Role of Procedural Videos in Teaching the Surgery Residents

A randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS) Islamabad after approval from the Institutional ethics review board. Fifty-four surgical residents in training and who have completed at least 3 months of surgical training were enrolled in the study. After the residents had performed the procedure initially, 27 were made to watch the procedural videos and learn the steps of the procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure. GARS (global assessment rating score) was calculated for each individual during their second procedure. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment of the GARS (global assessment rating score).

This study was conducted in 2 phases. In Phase-I just after the enrollment, all the residents performed the procedure from which initial GARS (global assessment rating score) assessment was made. Phase-I was followed by allocation into the groups i.e., study and control groups. In phase-2, a video of surgical procedure was obtained through internet. After all residents have done the procedure initially, 27 participants of the study group were made to watch the videos and learn the steps of procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure again. GARS (global assessment rating score) was calculated for each individual in their second procedure which included following scores:

1. Respect for tissue
2. Time and motion
3. Instrument Handling
4. Depth perception
5. Bimanual Dexterity All elements scored between 1-5 with a total of 25 score. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment according to the GARS (global assessment rating score).

Eligibility Criteria:
Inclusion Criteria:

* All the postgraduate trainees in surgery and allied specialties
* Age 25 to 35 years
* Both Genders
* Any year of training with at least 3 months of surgical training.

Exclusion Criteria:

* Those residents who did not wish to participate
* Those with less than 3 months of training.
* Consultant surgeons