cyrilzakka/clinical-trials huggingface dataset:
A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
* Age ≥18 years at time of nivolumab treatment initiation
* Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
* Charts/records include treatment start date of nivolumab
* Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion

Exclusion Criteria:

* Currently enrolled in an interventional clinical trial for their SCCHN
* Received systemic treatment for any other primary cancer within 6 months of study enrolment
The Safety and Effectiveness of 935U83 in HIV-Infected Patients

To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.

Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Recommended:

* PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.

Allowed:

* Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.

Patients must have:

* HIV infection.
* CD4 count 200 - 500 cells/mm3.
* No history of or current AIDS-defining indicator disease by CDC criteria.
* No antiretroviral therapy within the past 6 months.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patient with the following symptoms or conditions are excluded:

* Current evidence of chronic hepatitis of any etiology.
* Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapy.
* Other antiretroviral drugs.
* Immunomodulators.
* Foscarnet.
* GM-CSF or G-CSF.
* Erythropoietin.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior conditions are excluded:

History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.

Prior Medication:

Excluded within the past 6 months:

* Any antiretroviral therapy.
* HIV immunotherapeutic vaccine.

Excluded within the past 4 weeks:

* Cytotoxic chemotherapy.
* Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.

Prior Treatment:

Excluded within the past 4 weeks:

* Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.
Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery

Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip arthroplasty with posterolateral approach.

Exclusion Criteria:

* Known allergy to levobupivacaine and / or piritramide
* Known neurological disorders or peripheral neuropathies
* Existing drug or alcohol abuse
* Chronic use of pain medication (\> started 3 months ago) not related to the hip suffering
* Coagulopathy (international normalized ratio) \> 1.4
* Thrombocytopenia \<70,000 platelets,
* Dementia
* Pregnancy
* Local infection hip
* Hepatic and / or renal impairment
* BMI\> 45.
Association Between Muscular Tissue Oxygen Saturation and AKI in Older Patients Undergoing Major Abdominal Surgery

The aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore have the potential to be used as therapeutic targets in future.

Acute kidney injury is one of the common and serious complications after major abdominal surgeries,which a reported incidence is as high as 7.5-13.4%.The evidence shows that nearly 20% of elder patients with comorbidity are severely related to postoperative AKI,which lead to increased complications, prolonged stays in hospital and higher mortality.What'more,even smaller increases in the levels of serum creatinine (sCr) may predict worse kidney function after 1or 2 years.But there is no effective treatment or strategy for acute kidney injury at the moment.Therefore,early identification and prevention for AKI in perioperative period are key points.

The mechanism of AKI is complex and multifaceted,which includes that surgeries or anesthesia lead to renal hypoperfusion,ischemia and hypoxia. If the anesthesiologists can monitor the oxygenation status of renal tissues and improve it during surgery, it may reduce the incidence of AKI.

Near-infrared spectroscopy (NIRS) is a new noninvasive technique that continuously monitors tissue oxygen saturation by measuring the relative concentrations of oxygenated and deoxygenated hemoglobin within a local tissue area.It has been improved that perioperative muscular oxygen saturation is related to patients outcome.A observational study showed an association between lower intraoperative tissue oxygen saturation monitored on both sides of paraspinal muscle and higher risk of postoperative AKI in patients having cardiac surgery, suggesting a potential similarity of tissue perfusion and oxygenation between renal and muscular tissue beds.

Therefore,in this study, the investigator hypothesizes that monitoring muscular oxygen saturation during period may reflect some part of renal tissue oxygen saturation and associate with postoperative AKI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years old,
* ASA scoreⅠ-Ⅲ,
* Scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries

Exclusion Criteria:

* Urological surgery or procedure related to renal tissue may be performed during surgeries.
* Nephrectomy or partial nephrectomy was performed before surgeries.
* Preoperative glomerular filtration rate\<30ml/1.73m2, or end-stage renal disease or renal transplant.
* Poor hearing or vision and language barrier impeding postoperative assessment.
* Skin condition incompatible with the adhesive oximetry probe.
* Refuse to participate in the trial.
KIDScore D3 Clinical Study

The aim of this study is to demonstrate that the KIDScore D3 may be used to identify those embryos on Day 3 that are most likely to form blastocysts.

The safety and effectiveness of the KIDScore D3 was investigated in a prospective study. The study was performed as a single arm, multicenter clinical study conducted at six sites in the United States. This was a non-interventional clinical study where the KIDScore D3 was not used during patient treatment. Briefly, the purpose of the study was to collect data to evaluate the safety and effectiveness of the KIDScore D3's ability to predict which embryos are most likely to develop to blastocyst stage. This was evaluated by using the KIDScore D3 as adjunct information to traditional morphological grading. Imaging data was collected on embryos cultured to day 5. Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores.

This study aims at analyzing the utilization of established morphology methods with adjunct outcome of an algorithm (KIDScore D3) that provides a score (1 - 5) from timings of morphokinetic events.

A double-blinded, multi-center study, designed to evaluate the odds ratios and other measures for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3 morphology with KIDScore D3 results as adjunct information.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF treatment

Exclusion Criteria:

* Less than 5 actively dividing embryos
Infiltration Anesthesia vs. Block Anesthesia

Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction

Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration. In comparison, the second group will receive a conventional inferior alveolar nerve block technique with 2% lidocaine with epinephrine (1:80,000). Pain will be measured para-operatively using a verbal rating scale.

Eligibility Criteria:
Inclusion Criteria:

* The systemic condition must be normal.
* Patient has no cardiovascular, metabolic, or transmitted disease.
* The patient has a Mandibular 1st. Molar tooth indicated for extraction.
* The tooth is non-restorable.

Exclusion Criteria:

* Chronic cardiovascular condition, metabolic, or infectious disease.
* Pregnant women.
* The tooth is restorable.
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test

This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The reliability of the triglyceride results in this test are compared to the reliability of the glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically accepted metabolic test.


Eligibility Criteria:
Inclusion Criteria:

* Free of chronic disease
* Normal (healthy) fasting glucose and triglycerides

Exclusion Criteria:

* Presence of pace-maker
* Pregnant
* Using tobacco products
* Using medications or dietary supplements that could modify primary outcomes
Research on the Diagnostic Value of Machine Learning Model Based on Clinical Data in Patients With Coronary Heart Disease

Based on the clinical data of patients, a machine learning model for coronary heart disease diagnosis was established to evaluate whether the model could improve the accuracy of coronary heart disease diagnosis, and to evaluate its authenticity, reliability and benefits.

A total of 300 patients with CHD WHO were hospitalized in the First Affiliated Hospital of Xinjiang Medical University from August 2021 to February 2022 were selected, all of whom met the DIAGNOSTIC criteria of CHD formulated by the World Health Organization (WHO) and excluded diseases such as highly severe valvular disease and congenital heart disease.A total of 300 healthy subjects from the First Affiliated Hospital of Xinjiang Medical University during the same period were selected as controls.Observation indicators included: Clinical indicators collected included: General conditions: gender, age, medical history;Blood biochemical indexes, such as blood routine, liver function, kidney function, blood lipid, blood glucose, myocardial markers, electrolyte, serum creatinine concentration, body mass index, BNP and other indicators;Related tests such as ELECTROcardiogram, holter electrocardiogram, cardiac ultrasound (left atrial diameter, ascending aorta, ventricular septal thickness, left posterior wall thickness, right ventricular diameter, ejection fraction, abnormal ventricular wall motion, evidence of infarction or ischemia, valve abnormality, congenital heart disease, etc.);Signs include: audio data of heart sounds in nine parts of precardiac area;Medication status.All blood biochemical indexes and examinations were completed in the laboratory department and ultrasound department of our hospital, and the physical signs were completed in the ward.The results of coronary angiography, pre-hospital and post-hospital echocardiography and other related data were recorded.Machine learning model was constructed based on clinical data to assist diagnosis of patients with coronary heart disease

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the diagnostic criteria for CHD set by the World Health Organization

Exclusion Criteria:

* Exclude serious valvular disease, congenital heart disease, respiratory system and other diseases.
Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors.

It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons).

In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.


Eligibility Criteria:
Inclusion Criteria:

Men or women

Age 18-70

Waist circumference \> 80 cm for women / \> 94 cm for men

Plus at least one additional established risk factor for the metabolic syndrome using the following criteria:

* Elevated BP (Systolic BP \> 130 mmHg and/or diastolic BP \> 85 mmHg);
* Elevated triglycerides (\>1.7 mmol/l);
* Reduced HDL-C (\<1.0 mmol/l for men and \< 1.3 mmol/l for women);
* Elevated fasting glucose (\> 5.6 mmol/l). BMI 18.5 - 35 kg/m2

Exclusion Criteria:

Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study)

Milk allergy

Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)

\>10 hours of strenuous physical activity per week

Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety)

Drug or alcohol abuse

Blood donation \<1 month before study commencement and during study period

Simultaneous participation in other clinical studies

Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months.

Inability to comply with the procedures required by the protocol
Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP)

The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty and dysphagia among OSA patients.

The research will be divided into three stages. The first stage will investigate the incidence of OSA in patients over 50 years old using the National Health Insurance Research Database (NHIRD). The second stage will examine the relationships among OSA, oral frailty, and dysphagia through an observational case-control study with 225 OSA patients and 225 controls. The third stage will evaluate the effects of CPAP treatment on oral frailty and dysphagia among moderate-severe OSA persons through a prospective cohort study with repeat four times measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years or older.
* Medically diagnosed with obstructive sleep apnea (apnea and hypopnea index, AHI, ≥ 5 events per hour).
* Clear consciousness and able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* Central sleep apnea patients.
* Patients with neurological or muscular disorders (such as stroke or Parkinson's disease).
* Patients diagnosed with oral cancer currently undergoing oral treatment.
Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.

Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.

Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.

Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.

Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.


Eligibility Criteria:
Inclusion Criteria:

1. Diamniotic twin pregnancy
2. Gestational age ± 28 weeks.

Exclusion Criteria:

1. Higher multiple pregnancy
2. IUFD of one or both fetuses
3. Any congenital anomalies
4. IUGR or discordant twins
5. PROM
6. If there is any contraindication to progesterone treatment
7. Women who did performed cervical cerclage in the current pregnancy
8. Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).
9. Threatened preterm labor.
10. Polyhydromnis.
11. Other medical disorder with pregnancy
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis

The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease


Eligibility Criteria:
Inclusion Criteria:

* Generalized moderate to advanced chronic periodontitis, five sites with probing depths of \>5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants

Exclusion Criteria:

* Allergy to tetracycline
* Subjects with aggressive periodontitis
* Acute necrotizing ulcerative gingivitis, or gross decay
* Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
* Individuals requiring prophylactic antibiotics
* Any periodontal therapy within the previous 3 months (excluding maintenance therapy)
* Systemic or local antibiotic therapy within three months
Impact of Stress Management Training After Cardiac Transplantation

In spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. Anxiety and depression are especially frequent. They impact significantly morbidity and mortality. Especially because they are associated with poor therapeutic adherence and risks of infection and rejection. The inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. This results in an important deterioration in quality of life of patients.

The investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.


Eligibility Criteria:
Inclusion Criteria:

* Men and women on the cardiac transplantation waiting list
* Patients aged 18 years and older
* Signed written informed consent
* Patients under the social security
* Patients with a somatic condition allowing travels
* Patients mastering the French language
* Class II or III NYHA patients

Exclusion Criteria:

* Patients minor or under protection measures
* Patient who have not signed written informed consent
* Patients not mastering the French language
* Patients with psychiatric illness characterized by the axis 1 of DSM IV R
* Patients receiving a psychotherapy or with a psychiatric care
* class IV NYHA patients