cyrilzakka/clinical-trials huggingface dataset:
Abutment Macro Design and Peri-implant Tissues

The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.

Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.

Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).

Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).

The patients will be restored with single crowns 3 months following implant installation.

A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.

Eligibility Criteria:
General Inclusion criteria:

* - Age more than 21 years
* Absence of relevant medical conditions
* Availability for 12 month follow-up

Specific Inclusion criteria:

* One missing tooth in the maxillary premolar region
* Presence of two adjacent teeth at the implant site
* Absence of periodontal disease
* Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm

General Exclusion Criteria:

* - Pregnancy at the screening visit.
* Smoking more than 10 cig/day

Specific Exclusion criteria:

* Adjacent implants
* Presence of periapical radiolucency at the adjacent teeth
* Missing adjacent teeth
PFU Vs. UDS in SUI

The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is:

Is Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years

Exclusion Criteria:

* Medical history of neurological disorders, cognitive disorders, dementia, Alzheimer's disease, or uncontrolled DM.
* Surgical history of continence or prolapse procedure.
* Examination showing anterior or middle compartment decent with POP-Q staging greater than stage 1, or urogenital fistula.
* Known lower urinary tract or genital tract anomalies or tumors.
A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs

The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy (HAART). This study also examines the effect tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.

Patients are enrolled sequentially into the next available dosage cohort. Each cohort receives a single dose of tucaresol, is observed for 2 weeks, and then receives 3 alternate-day doses of drug and careful safety monitoring, including 4 weeks follow-up after the final dose. Dose cohorts receive drug sequentially, the lowest-dose cohort receiving the drug first. Dose escalation may not proceed to the next higher-dose cohort until all patients from the prior lower-dose cohort have completed the 4-week follow-up after the multiple dosing, adverse events are within the described bounds, and the FDA has reviewed the safety information from the treated cohort and approved the dose escalation. The drug is administered 4 times within the 8 weeks of the study period. Weekly visits are required. Patients receive financial compensation.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Have more than 300 CD4 T cells/microL at screening.
* Are taking certain anti-HIV drugs.
* Have been taking these anti-HIV drugs successfully for at least 6 months.
* Do not expect to change their anti-HIV therapy while they are in the study.
* Have had plasma viral load less than 50 copies/ml while on their anti-HIV therapy.
* Have viral load that cannot be detected at screening and baseline tests.
* Are able to complete weekly visits.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Cannot give informed consent.
* Have abnormal laboratory test results at baseline.
* Are pregnant or breast-feeding.
* Have had certain short-term or long-term illnesses (such as heart disease, sickle cell disease, anemia, or lung problems).
* Have received a vaccination within the 30 days prior to enrollment.
* Have received any other experimental drug within 60 days of enrollment.
* Are taking abacavir (Ziagen, GW1592) or drugs that affect the immune system, such as IL-2, GM-CSF, corticosteroids, or cyclosporine.
* Have a history of tumors.
* Are actively using illegal drugs (methadone is allowed).
* Have hepatitis B or hepatitis C.
Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.

The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.

1. Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers.
2. Methods

   1. design: a randomized controlled single-blind design is used with 3 measurement moments. We measure at baseline (before start of OT intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement).
   2. patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot study (Graff, et al., 2003).
   3. intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guideline.The control group receives no OT intervention, but usual care.
   4. main outcome measures are: Assessment of Motor and Process Skills, Interview in Deterioration of Daily Activities in Dementia (IDDD)and Sense of Competence Questionnaire (SCQ)
   5. Analysis: analyses of covariance on intention-to-treat basis (Last Observation Carried Forward (LCOF))will be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. Also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis.
   6. Cost-effectiveness: the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out.

      3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or older
* mild to moderate dementia (MMSE 10-24)
* living in the community at maximum of 50 kilometers from the Memory Clinic
* having an informal primary caregiver who was involved in the care for the patient at least once a week

Exclusion Criteria:

* depression: score \> 12 on the Geriatric Depression Scale
* severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
* severe illnesses, judged by a geriatrician
* no OT goals, determined by the researcher or research assistant
* caregivers having severe illnesses
Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)

Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.


Eligibility Criteria:
Inclusion Criteria:

Positive COVID test Endotracheal Intubation P:F \<150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.

Exclusion Criteria:

Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (\<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for \>48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions

The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.

Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
Study of WPV01 in Healthy Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects signed an informed consent form with full understanding of the test content, procedure and possible adverse effects
* Chinese healthy male or female subjects between aged from 18 to 45 years
* Subjects must agree to comply with the contraceptive requirements during the trial and for 3 months after the last dose
* Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index in the range of 18.0 \~ 28.0 kg/m2 (including 18.0 and 28.0)
* Subjects must be willing to understand and comply with study procedures and limitations, have the ability to complete the trial as planned, and be able to communicate effectively with the investigator

Exclusion Criteria:

* Participants who have special dietary requirements and cannot abide by the provided food
* Pregnant or lactating women; Women who have pregnancy plan 1 month before trail, during trail or within 3 months after last dose; Women with positive serum pregnancy tests at screening or baseline
* Participants who have evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
* Participants who have history of any other acute or chronic illness
* Participants who have known allergy to any ingredient in the study treatment drug
* Participants who are judged by the investigator to be unsuitable to participate in this study
Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)

This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.

Participants and healthy controls will be consented into the study. After consent, details including age, duration of disease, ALSFRS score, and grip strength will be collected. Participants will be trained to perform a grip and release task using a foam ball for 1 minute while inside an MRI scanner. Anatomical, functional and diffusion MRI sequences will be acquired during the scanning, and total scan time will be approximately 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Based on El Escorial Criteria we will select Probable or Definite ALS.
* Healthy controls age matched to ALS patients
* Subjects should be able to lie down in a scanner and undergo an hour-long MRI study
* Subjects should be able to understand instructions, provide consent and perform a hand task while inside the scanner

Exclusion Criteria:

* Unable to undergo MRI due to any reason
* Age \<18
* ALS patients having high aspiration risk
* Patients having cognitive limitations which prevents them from understanding the study requirements, providing consent or perform tasks inside the scanner.
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population

This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use.

Study primary objective is to identify the inappropriate use of PPI (overall, outpatient \& inpatient).

Eligibility Criteria:
Inclusion Criteria:

* All patients in 2015 China Health Insurance Research Association (CHIRA) database.
* Patients had PPI prescription during Jan. 2015 to Dec. 2015 will be selected to estimate the PPI inappropriate use.

Exclusion Criteria:

• Patients without data of treatment information.
CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.

Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy is recommended for advanced NSCLC patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). This category of patients represents about 20% of all patients at initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. Studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV);
* No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);
* ECOG performance status 2;
* Age: \> or = 18 and \< 70 years;
* Life expectancy at least 4 weeks;
* Normal bone marrow, hepatic and renal function defined as: neutrophils \> or = 2000/mm3, PLT \> or = 100,000/mm3, Hb \> or = 10.0 g/dl, Bilirubin \> or = 1.5 times the upper normal limit (UNL), AST and ALT \< or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits;
* Signed informed consent.

Exclusion Criteria:

* Active systemic infections;
* Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);
* Inadequate hepatic or renal function;
* Radiation therapy ongoing or concluded within two weeks prior to enrollment;
* Symptomatic cerebral metastases;
* Previous chemotherapy for advanced disease;
* Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;
* Pregnant or nursing females;
* Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
Polyurethane Foam on the Heel for Prevention in Children

The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \> 3 years underwent surgery for flat foot
* Children with intact skin at the heel

Exclusion Criteria:

* Caregivers who cannot speak Italian
* Those who refuse to give their consent to take part in the study
* Patients with lower limb casts after surgery
Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.


Eligibility Criteria:
Inclusion Criteria:

* Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery

Exclusion Criteria:

* Presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the Investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of Inflammation and / or infection;
* Present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event;
* Previous diagnosis of alcohol and drug abuse defined by DSM-V;
* Current or past history (for less than 12 months) of smoking;
* Use of illicit drugs;
* History of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage;
* Any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ECG) observation that is interpreted by the investigating physician as a risk to the participant;
* Use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the Investigator;
* Known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine);
* Women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hCG) during the study screening / selection period;
* Professionals directly involved in the realization of the present study and their relatives;
* Participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the Investigator deems that there may be direct benefit to it.
The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

Although blood transfusion is a representative treatment for acute anemia due to blood loss during surgery, it is also a powerful risk factor for postoperative cognitive dysfunction.

'Restrictive transfusion', which transfusions minimal red blood cells, is not only useful for conserving limited blood resources, but also does not worsen prognosis or mortality after surgery. Research has also been reported that severe restrictive transfusion has improved prognosis and mortality.

However, anemia is also one of the risk factors for postoperative complications, including neurocognitive impairment, it is still controversial how much anemia should be allowed in elderly people who are sensitive to ischemia or heart disease.

The purpose of this study is to determine whether the restrictive transfusion policy reduces the frequency of postoperative cognitive dysfunction than the liberal transfusion policy in patients aged 65 years or older who undergo lumbar interbody fusion.

Restrictive transfusion strategy (which initiates transfusion when hemoglobin level is less than 8 g / dL during perioperative period) // liberal transfusion strategy (which initiates transfusion when hemoglobin level is less than 10 g / dL during perioperative period)

The Aim of this study was to compare the frequency of postoperative cognitive dysfunction diagnosed 7 days after surgery between two groups.

K-MOCA (Korean-Montreal Cognitive Assessment) is used to evaluate cognitive dysfunction. In addition, plasma inflammatory markers (CRP, IL-6) and GFAP reflecting brain damage were measured before and after surgery to determine whether brain injury caused by systemic inflammatory response is associated with cognitive dysfunction

Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion

Exclusion Criteria:

* If patients have anemia (Hb is less than 13 g / dL for men and less than 12 g / dL for women)
* Those who cannot read the agreement (illiteracy, foreigner, etc.)
* Have a history of taking medication for mental illness
* Communication disorders due to neurological diseases (dementia, stroke, seizures, etc.)
* Less than 23 points on K-MoCA test
* When fluid loading and volulyte are difficult due to kidney disease
* Limited blood transfusion due to heart disease
* Refusal of blood transfusions (religious reasons, etc.)
* patients who have received a blood transfusion within 6 weeks prior to surgery
* If continuous observation is impossible after surgery
* Emergency surgery