cyrilzakka/clinical-trials huggingface dataset:
Crestal vs Lateral Sinus Lift Augmentation

The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.

Each patient having bilateral edentulism in posterior maxillae was randomised to receive one partial fixed prosthesis supported by one to three implants placed either with a crestal or with lateral window sinus lift procedure.

Eligibility criteria for participants

Only healed implant sites were considered (at least 3 months after tooth extraction). The vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.

Patients were not admitted in the study if any of the following exclusion criteria was present:

general contraindications to implant surgery subjected to irradiation in the head and neck area immunosuppressed or immunocompromised treated or under treatment with intravenous amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended for implant placement acute or chronic infection/inflammation in the area intended for sinus augmentation/implant placement referred only for implant placement who cannot be rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading follow-up. Smokers were included and patients were categorised into three groups according to what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii) heavy smokers if smoking more than 10 cigarettes/day.

Patients were recruited and treated in one private practice in Tirana, Albania by two operators: Marco Tallarico who performed all surgical interventions and Erta Xhanari who performed all prosthetic and maintenance procedures.

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patient
* Bilateral edentulism in posterior maxillae (premolars and molars)
* 18 years or older
* Able to understand and sign an informed consent.
* At least 3 months after tooth extraction
* Vertical bone height at the implant sites between 2 to 6 mm
* Bone thickness at least 6 mm as measured on CBCT scan

Exclusion Criteria:

* general contraindications to implant surgery
* subjected to irradiation in the head and neck area
* immunosuppressed or immunocompromised
* treated or under treatment with intravenous amino-bisphosphonates
* poor oral hygiene and motivation
* untreated periodontal disease
* uncontrolled diabetes
* pregnant or lactating
* substance abusers
* psychiatric problems
* unrealistic expectations
* lack of opposite occluding dentition/prosthesis
* acute or chronic infection/inflammation
* augmentation/implant placement
* referred only for implant placement
Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial

The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria;
2. Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled.
3. Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously).
4. With measurable foci, defined as: lymph nodes with long diameters\>15mm，extra-nodal foci\>10mm on CT scan;
5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;

Exclusion Criteria:

1. Invasive NK cell leukemia;
2. Primary CNS lymphoma or CNS-involved lymphoma;
3. Patients with hemophagocytic syndrome;
4. Patients with lymphoma invading large pulmonary vessels;
5. Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

Three month treatment of acute VTE with Fragmin in pediatric cancer patients

Primary study objectives include are to determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (VTE), using anti-Xa (Xa) levels and a population PD analysis methodology, and to determine the median dose required to achieve therapeutic anti- Xa levels (0.5 to 1.0 International Units \[IU\]/mL) based on subject age and weight.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Follow-Up of the Prevision® Hip Stem

The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem.


Eligibility Criteria:
Inclusion Criteria:

* All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019
* Written informed patient consent

Exclusion Criteria:

- Patients \< 18 years at surgery
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria:

1. Primary outcome: patient satisfaction via surveys used in prior publications
2. Secondary outcome: length of time to return to work
3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's
4. Secondary outcome: complication rates


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18 and 75
2. Documented clinical and electromyography (EMG) proven carpal tunnel syndrome

Exclusion Criteria:

1. Recurrent carpal tunnel syndrome
2. Inflammatory arthropathy
3. Peripheral neuropathy
4. Diabetes
5. \< 18 or \> 75 years old
6. Pregnant at the time of enrollment
Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible for resection surgery (lobectomy or pneumonectomy)
* Age \> 18 years
* Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced expiratory volume (FEV )/ forced vital capacity (FVC) \<70%, FEV \<80% of predicted) and Exertional dyspnea stage MMRC (Medical Research Council) \> 1
* Patients must provide written consent
* Member of social security scheme

Exclusion Criteria:

* Patients refusing to participate
* COPD stage 1 Gold (VEMS \>= 80% of the theoretical value)
* Presenting an operating contraindication during the initial maximal exercise test
* Presenting cardiac or vascular contraindication to achieve the readaptation program
* Patient living alone at home
* Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation (NIV))
* With exercise hypoventilation (PaCO2 \>45 mmHg)
* Cognitive difficulty
* unable major
* pregnancy,
* patients deprived of liberty by a court or administrative decision
Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation

Pseudohypoaldosteronism is a pathology affecting children under 6 months of age, little known but which can have serious consequences.

There are no real figures on the prevalence of this pathology in France. The exact pathophysiology is not known and the management is not currently codified.

This is why it is interesting to study this pathology and its treatment on a national scale in order to think about the best possible treatment, as well as to raise awareness of this pathology among different health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Minor subjects aged less than 6 years at the time of diagnosis
* Diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023
* Subject (and/or their parental authority) having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject (or their parents) having expressed their (their) opposition to participating in the study
Mask Ventilation With Different Face Masks During Neonatal Resuscitation

Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.

To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher \& Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital.

The purpose of this study is to find out if one facemask is leaking less between the face and the mask.

We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher \& Paykel (FP) (Fisher \& Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask. The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher \& Paykel mask.

A Respiratory Function Monitor will be placed between the face mask and the ventilation device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a face mask. This signal is automatically integrated to provide inspired and expired tidal volume. The difference equals the leak from the face mask. It also calculates respiratory rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration, temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at 200Hz using the Spectra physiological recording program (a customised neonatal respiratory physiology program).

We will compare the % of mask leak within the two face masks.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<32 weeks gestation born at The Royal Alexandra Hospital who require resuscitation in the delivery room will be recorded.

Exclusion Criteria:

* Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.

Participants will be included in the first minutes after birth if they require mask ventilation for poor respiratory effort. Data will be collected from the Hospital chart until discharge at around 40 weeks gestation.
Promotora Navigator - Culturally Appropriate Patient Navigator

Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Identifying as Hispanic ethnicity
* Age 40-64
* Tennessee resident

Exclusion Criteria:

* Personal history of breast cancer
* Current breast symptoms (palpable mass)
Comparison Study of Lay Person Finger Stick Versus Blood Draw

This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).

This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and follow verbal and written instructions in English
2. Demonstrate a willingness to participate by providing a written informed consent
3. Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
4. Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.

Exclusion Criteria:

1. Withdrawn informed consent
2. Mental or physical impairment which would preclude participation
3. Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.
Heart Disease on the Mend

The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.

The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life. Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California. Primary eligibility was ≥ 35 years of age, one or more CVD risk factors (with or without clinical CVD), low family income, and residing in Santa Clara County. Patients in the case management group were provided counseling services by specially trained registered nurses (RNs) and registered dieticians (RDs) and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies. Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized. On average patients in case management were seen by staff 6-9 in the 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 35 years
* One or more major risk factors
* Live in Santa Clara County
* Low family income that limits access to medical care

Exclusion Criteria:

* Under active medical treatment for cancer, CVD or other major medical disorder
* Reasonable access to health care
* Under 35 years of age
* Not a resident of Santa Clara County
The Effects of Breakfast on Brain Function

To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.


Eligibility Criteria:
Inclusion Criteria:

* 8-11 years old
* Between 25th and 95th percentile, BMI-for-age

Exclusion Criteria:

* food allergies or some intolerances
* uncorrected vision
* IQ \< 80
* Other chronic conditions thought to interfere with the study as determined by the investigator
Optimal Number of Pleural Biopsies During Pleuroscopy

A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who require pleuroscopies will be enrolled to the study.
* Age ≥ 18

Exclusion Criteria:

- Inability to provide informed consent
Cognitive Behavioral Therapy for Paranoia in Schizophrenia

The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that combines group and individual modalities to reduce paranoia-biased information-processing and social avoidance, and to increase insight and reality testing capacity.

This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory delusions will be recruited from outpatient clinics in New York City Metropolitan area. Participants will be randomly assigned to either experimental or control group. The experimental group will receive PFCBT in addition to standard care and the control group will receive standard care alone. PFCBT will include participation in one group session and one individual therapy session weekly over the 15 weeks. The preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and at 6-months post-termination follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Met DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder, confirmed by the Clinical Structural Diagnostic Interview (SCID, First et al, 1997) -Reported persistent and distressing paranoid delusion(s);
* A minimum severity score of 4 point Persecution subscale on The Positive and Negative Syndrome Scale (PANSS)
* Had an adequate trial (6 months or more) and were stabilized on antipsychotic medications (no change in psychiatric medication prescribed in the last month

Exclusion Criteria:

-Substance misuse or medical disorder identified as the primary cause of delusions