cyrilzakka/clinical-trials huggingface dataset:
PREHAB - Improving Condition Before Surgery

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

With the aim of achieving downstaging, downsizing, and reducing the risk of recurrence, neoadjuvant chemotherapy, possibly chemoradiotherapy - i.e. neoadjuvant therapy is indicated in the preoperative period for patients with cancer of the upper digestive tract and rectal cancer.

Chemotherapy has a negative impact not only on the overall physical and mental condition of the patient but also on the quality of life and on the daily activities of the individual, especially in the period when the organism is facing an abnormal stress load in the sense of extensive surgical procedures.

Recently, attention and efforts to improve postoperative morbidity and mortality have increasingly focused on the preoperative period. The concept of prehabilitation, which is defined as an intervention improving functional capacity before an upcoming physiological stressor, appears as a way to contribute to this. This fact is evidenced by a number of published references.

The main aim of the study is to confirm or refute the feasibility of the prehabilitation program during neoadjuvant therapy in two diagnostic groups of patients:

* - Patients with cancer of the upper digestive tract
* - Patients with rectal cancer

The prehabilitation program will be implemented in the patient's home environment.

The study aims to answer the basic research question of whether selected patients will be able to complete a home exercise regimen during the preoperative period when they will undergo neoadjuvant therapy.

As part of the study, the program's security and feasibility will be tested.

Eligibility Criteria:
Inclusion Criteria:

* radically operable locally advanced cancer of the esophagus, esophagogastric junction, stomach
* radically operable locally advanced carcinoma of the rectum
* the patient is able to handle the planned surgical resection procedure
* planned preoperative neoadjuvant therapy
* age \> 18 years
* the ability to complete a spiroergometric examination
* the ability to carry out a prehabilitation program consent to participate in the study confirmed by signing the informed consent

Exclusion Criteria:

* contraindications for spiroergometric examination
* limitation on the part of the locomotor system to spiroergometric examination or daily exercise (e.g. amputation, severe gonarthrosis, coxarthrosis)
* inoperability determined by the interdisciplinary team
* inability to manage the planned operational performance
* acute surgical performance
* synchronous malignant disease
* multivisceral resection
* planned non-surgical therapeutic procedure
* incomplete data
Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers

Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, based on a complete medical examination
* Age range from 21 to 50 years
* Participant must be within +/- 20 % of their normal weight (Broca-Index)
* Participant must provide written informed consent

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than then half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to start of the study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse
* Drug abuse
* Blood donation (\> 100 ml) within four weeks prior to administration
* Other disease or abnormality of clinical relevance
* Excessive physical activities within two weeks prior to administration or during the trial
Shoe Modification and Knee Osteoarthritis

This trial will assess the ability of shoe inserts to relieve pain and disability in people with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.

Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Its prevalence increases with age, leading to about 65-85% of those age 65 years and older having OA. Involvement of the knee with OA is the main reason for significant functional impairment as it alters ambulation through pain and stiffness. Nonpharmacological management of knee OA includes the use of orthotic supports such as wedged insoles for varus or valgus knee deformities to relieve pain and improve function in the early stages of this joint disease. Although these interventions are desirable because they are simple and inexpensive, we do not have a clear understanding about their efficacy in relieving pain and disability in people with knee OA. We also do not know whether there is a relationship between changes in joint biomechanics that occur with wedged insoles and changes in function and progression of OA. Furthermore, information is lacking regarding which patients would benefit from wedged insoles. Answering these questions will be critically important in the development of guidelines for the prescription of wedged insoles in knee OA. Patients in this study will be evaluated at baseline and after wearing the lateral-wedged insoles immediately and after wearing the insoles for four weeks. The participants will wear lateral-wedged insoles for the painful knee(s) for as many hours and for as many days of the week as they can tolerate. Some subjects may use a neutral position insole for an asymptomatic knee.

Eligibility Criteria:
Inclusion Criteria:

* Ability to walk 30 feet without a walking aid
* Ability to stand unaided
* Ability to understand verbal instructions
* Ability to give informed consent

Exclusion Criteria:

* History of knee trauma or surgery including arthroscopic surgery in the past 6 months
* Severe obesity (\>30 kg/m2)
* Neurological disease
* Injury or amputation to the lower extremity joints
* History of other types of arthritis
* Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee
* Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months
* Poor health that would impair compliance or assessment such as shortness of breath with exertion
Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease

The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2 major criteria and at least one minor criteria.

Major criteria : Age \> 50 ans ; headache ; intermittent jaw or tongue pain ; visual impairment ; ESR \> 50 mm at 1h and/or CRP \> 8mg/l.

Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever \>38°C, weight loss \>10%, anorexia, fatigue.

Exclusion Criteria:

* Autoimmune disease
* Active infectious condition
* Malignant disease
* Condition counterindicating one or several of the protocol's imaging procedures : allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic foreign body...
Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics

Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.


Eligibility Criteria:
Inclusion criteria:

* Suspicious of bladder cancer scheduled to have transurethral resection of bladder tumor
* Consent to the provision of their biospecimen.
* Willing to cooperate with this study and comply with the restrictions.
* Voluntarily signed the consent form for participation in the study.
* Age ≥18.

Exclusion criteria:

* Do not agree with this study.
* Vulnerable participants
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers

Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* From 18-60 years old, and able to read and sign the informed consent document.
* Patients with teeth problems indicated for laminate veneers.
* Physically and psychologically able to tolerate conventional restorative procedures.
* Have no active periodontal or pulpal diseases.
* Maintenance of good oral hygiene .
* Willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patients with para-functional habits.
* Cases that need modification in the incisal edge.
* Patients with poor oral hygiene and motivation .
* Psychiatric problems or unrealistic expectations.
Comparison of Hand Functions and Wrist Proprioception in Patients With and Without Psoriatic Arthritis

The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA.

In this study, 54 patients (18 of them RA, 18 of them PsA and, 18 of them asymptomatic healthy group) were included. The patient group was selected from the patients who came to the Izmir Katip Celebi University Ataturk Training and Research Hospital Rheumatology Outpatient Clinic for routine control.

Participants were matched according to age and gender. It was recorded demographic and clinical data.

Grip and pinch strengths were evaluated within the scope of hand function evaluation. Wrist joint position sense was evaluated along with hand functions.

Eligibility Criteria:
Inclusion Criteria:

* to be diagnosed according to CASPAR or ACR/ EULAR 2010 criteria for patient groups
* taking regular medication for patient groups,
* have complaints related to hand / wrist joints for patients groups,
* have no complaints related to upper extremity for asymptomatic healthy group.
* have any rheumatologic disease and OA diagnosed according to traditional criteria

Exclusion Criteria:

* finger infection and / or finger amputation,
* using orthoses,
* to report a diagnosis of neurological disease,
* to report a history of trauma or surgery involving the upper extremity,
* to report a psychiatric and / or cognitive problem
Performance Evaluation Study for Clearblue Pregnancy Test

The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.

Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.

Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study and agree to comply with study procedures.
* Has menstrual bleeds.
* Seeking to become pregnant.
* Intend to seek medical care during pregnancy.

Exclusion Criteria:

* Has positive pregnancy test on screening.
* Has received medical treatment for infertility or is participating in an assisted fertility program.
* Known condition to contra-indicate pregnancy.
The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment

Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. The recruited participants were respiratory internal medicine trainees undergoing further training.
2. They were willing to undertake relevant training and complete the experiment persistently -

Exclusion Criteria:

If the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.

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Effects of Different Anesthesia on Odor Memory

This study aimed to research the effect of different general anesthesia administration on postoperative smell functions and memory.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II risk groups
* operated under elective conditions with general anesthesia requiring intubation
* operation durations of 40-180 minutes.

Exclusion Criteria:

* intracranial,
* endocrine or nasal surgery,
* pregnant cases,
* those with history of respiratory tract diseases and psychiatric disease, with disorder of odor reception and perception,
* with smoking and chronic alcohol use,
* requiring a nasogastric probe
Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension

To determine whether impedance cardiography (ICG) parameters can predict favorable or unfavorable blood pressure (BP) response and time to BP control prior to initiation or intensification of specific antihypertensive drug classes and drug combinations, independent of initial BP levels.

* Patients with higher vascular resistance index and/or lower arterial compliance index will lower BP faster and to a greater degree overall when receiving vasodilating agents - such as ACEI's, ARB's, dihydropyridine CCB's, direct vasodilators, and central alpha agonists.
* Patients with an elevated cardiac index will lower BP faster and to a greater degree overall when receiving agents that reduce contractility, heart rate, or blood volume - such as beta blockers, non-dihydropyridine CCB's, and other agents that are known to reduce cardiac index.
* Patients with an elevated thoracic fluid content or lower orthostatic change in thoracic fluid content will lower BP faster and to a greater degree overall when receiving diuretics (thiazide, loop, potassium sparing), however - one of these agents will emerge as a superior alternative to reduce BP in patients with high thoracic fluid content / low orthostatic change in thoracic fluid content.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Able to provide written consent
* Meet JNC definition of hypertension
* Lab results with 6 months for: serum creatinine, urine albumin/creatinine ratio, and at least one of the following: serum glucose, or glycated hemoglobin, or hemoglobin A1C

Exclusion Criteria:

* Active cardiovascular disease (unstable angina, stage C or D heart failure, uncontrolled superventricular arrhythmia, hx of ventricular arrhythmia, stroke or TIA within 6 months, ACS within 6 months)
* Implantation of activated ventricular pacemaker
* Known hypersensitivity or allergy to sensor gel or adhesives
* Skin lesions prohibiting sensor placement
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients

Intervention designed to promote healthy eating in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age
* Type 2 diabetes
* Poor dietary habits

Exclusion Criteria:

* Micro and macro-vascular complications
* Poor glycemic control
* Food allergy
Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.

The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18
2. Female or male
3. Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks

Exclusion Criteria:

1. Patients who cannot consent for themselves, including cognitively impaired patients.
2. Non-English speaking patients
3. Patients taking beta blocker medication
4. Patients that have a pacer and have a set rate
5. Patients with self-reported hearing problems or with hearing aids
Role of High Flow Nasal Oxygen as a Strategy for Weaning From Invasive Mechan

evaluate the Efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure.

Acute respiratory failure is a main cause of IMV and admission to intensive care unit (ICU){1}.

The day of extubation is a critical time during an intensive care unit (ICU) stay because in case of postextubation failure {2},which reach to 25 - 40% from extubated patient associated with VAP and barotrauma, mortality rate and hospital stay will increase , we use Adjuvant oxygen therapy to prevent these undesirable event like COT ,NIV and High-flow nasal cannula (HFNC) which can be used as an initial weaning strategy from IMVdue to its physiologic benefits \[3-4\].

HFNC devices supply between 30 and 60 L/min of a controlled mixture of actively warmed (32-37 °C) and humidified (up to 100% relative humidity) oxygen and air through modified nasal prongs. producing {5-6-7}:

1. moderate positive end-expiratory pressure (PEEP) .
2. HFNC might help prevent extubation failure through different

Mechanisms:

1. First, the controlled oxygen concentration may reduce transient hypoxemic episodes .
2. Second, the high flow washes the nasopharyngeal dead space, thus reducing CO2 re-breathing; this effect reduces respiratory rate and minute ventilation .
3. Third, the small amount of PEEP may reduce lung collapse . c)enabling better gas exchange and reduced work of breathing. d)in patients with chronic obstructive pulmonary disease (COPD), this level of PEEP may counterbalance auto PEEP, further reducing the work of breathing.

e) humidification may improve mucus drainage and reduce mucus retention, alleviating the associated atelectasis.

Eligibility Criteria:
Inclusion Criteria:

1- All adult patients who were admitted to our ICU requiring endotracheal intubation (ETI), were eligible for the study.

Exclusion Criteria:

1. Non-intubated patients or those with tracheostomy were excluded from the study.
2. those having neurological alteration unrelated to hypercapnoeic encephalopathy, cranio-facial deformity, upper airway obstruction, cardiogenic pulmonary edema, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism, gastrointestinal bleeding, and post-operative respiratory failure.
3. Patients less than 18 y.
Hormonal Contraception and Risk of Chlamydia and Gonorrhea

There are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease. The evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results.

This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women: those using combined oral contraceptives (birth control pills); those using the injectable hormone (brand name Depo Provera); and those women using non-hormonal contraceptive methods.

The study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of Chlamydial and Gonococcal sexually transmitted infections, and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy.

Eight hundred and nineteen women, ages 15 to 45 years, were recruited from an inner city clinic and from a nearby suburban clinic. The women were classified into three groups based on type of contraceptive used. One group used oral contraceptives; the second used injectable depo-medroxyprogesterone acetate (DMPA); and the third group used non-hormonal contraceptive methods. Women from each group were followed at 3, 6, and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present.

Eligibility Criteria:
Inclusion Criteria:

* Female age 15 to 45 years
* no hormone use at enrollment
* not pregnant or planning pregnancy

Exclusion Criteria:

* Cervical cancer presently or in history
* hysterectomy, cone biopsy, or cervical cryotherapy