cyrilzakka/clinical-trials huggingface dataset:
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts

Eligibility Criteria:
Inclusion Criteria: Female Subjects who are pregnant or breastfeeding will be included (no risks to fetus).

Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. Thirty subjects from 6 different age groups (\> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; \> 60 yrs) will be recruited to determine the normal variations in anterior eye structure.

LASIK patients: to participate as a LASIK patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo LASIK.

Contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear.

Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of \>700 microns, and/or reduced visual acuity in the morning which improves over the course of the day.

Diabetic patients: for diabetic patients are specified in the posterior segment imaging section.

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Exclusion Criteria:Subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study.

If participants choose they may also participate in other imaging research protocols. No risk is associated if entering multiple imaging protocols, while being a participant in this research study.

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Exercise Prehabilitation for Patients With NSCLC Before Surgery

To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.


Eligibility Criteria:
Inclusion Criteria:

1. Capacity to give informed consent.
2. Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
3. Patients who can use a smartphone application.
4. Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
5. Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.

Exclusion Criteria:

1. Known contraindication for cardiopulmonary exercise testing.
2. Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
3. Pregnancy or lactating women.
Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma

Rationale:

Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes radiation and chemotherapy. However, due to the potential long-term central nervous system toxicity from radiation, researchers speculate that it may be better to reserve radiation therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates that brain tumor patients with a deletion of the 1p chromosome have a higher response to the chemotherapy drug temozolomide.

Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both relapse and initial diagnosis. This drug appears to have less adverse effects compared to other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in brain tumor patients compared to other brain tumor drugs. The current study builds on previous research to test the efficacy of chemotherapy alone in patients with anaplastic oligodendroglioma and mixed oligoastrocytoma.

Purpose:

This study will evaluate response rate, or how the disease size changes in patients, and survival without disease growth, in patients with anaplastic oligodendroglioma and mixed oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this patient population treated with the study regimen.

Treatment:

Study participants will be treated with the drug temozolomide. This drug will be administered in oral pills. Temozolomide will be taken for seven consecutive days followed by seven days without the drug. This treatment schedule of seven days on temozolomide followed by seven days off will continue throughout the study. Several tests and exams will be given to closely monitor patients. MRI scans will be performed every 8 weeks to measure disease response. Temozolomide as a study drug will be given to study participants for a total of 8 week four cycles. However, treatments will be discontinued due to disease growth or unacceptable adverse events.

Eligibility Criteria:
Inclusion Criteria:

* anaplastic oligodendroglioma or mixed oligoastrocytoma
* age \> 18
* Karnofsky status \> 70%
* adequate bone marrow, liver and renal function

Exclusion Criteria:

* prior chemotherapy or cranial irradiation
The Change in Temporal Muscle Thickness in Stroke Patients

This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.

It is well known that stroke increases the risk of developing sarcopenia . In addition, prestroke sarcopenia is associated with worse functional outcomes in patients with stroke. Temporal muscle thickness (TMT) has recently been proposed as a new marker of whole-body muscle mass and function. Measurement of temporal muscle mass by computed tomography (CT) and magnetic resonance imaging (MRI) has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. By evaluating the temporal muscle mass of these patients with these examinations, information about pre-stroke muscle mass and sarcopenia can be obtained. Ultrasonography (USG), on the other hand, may be a more accessible, less expensive, and safer option for assessing muscle mass in the follow-up of stroke patients. This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change by MRI/CT at admission and by USG in the chronic period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke
* Presence of cranial MRI/CT in hospital records

Exclusion Criteria:

* Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
* Severe cognitive impairment
* Patients who require intensive care unit.
GERD After Sleeve Gastrectomy

The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However, the relationship between SG and GERD is complex. The aim of this study is to systematically evaluate all published data existing in the literature to evaluate the effect of sleeve gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of this procedure.

This systematic review was conducted in accordance with the guidelines for Preferred Reporting Items for Systematic Review and Meta-analyzes (PRISMA).

Published studies that contained outcome data for primary sleeve gastrectomy associated with the primary and secondary outcomes listed below were included.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent to sleeve gastrectomy with reflux symptoms

Exclusion Criteria:

* Patients underwent to other bariatric procedures
MyBack - A Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences

Low Back Pain is a common heath condition with high rates of recurrence and huge associated costs. Research has focused its efforts on analysing the effects of interventions while knowledge about effective secondary prevention strategies is limited. MyBack study aims to analyse the effectiveness of a tailored exercise and behavioural change program (MyBack program) in the secondary prevention of low back pain, and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack program, through a hybrid type I, randomized, controlled and multicentre study of effectiveness and implementation in the context of primary health care.


Eligibility Criteria:
Inclusion Criteria:

* Recovered (within the last 3 months) from an episode of non-specific LBP (with or without leg pain and of any duration)
* Recovery from an LBP episode is defined as having a pain score of "0" or "1" on a 11-point Numeric Pain Rating Scale for, at least, 30 consecutive days
* Age between 18 and 65 years;
* Read and speak the Portuguese language;
* Having a mobile phone capable of receiving and sending text messages;
* No medical contraindication to exercise.

Exclusion Criteria:

* Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
* Pregnancy
* Spinal surgery in the last 6 months
Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery

Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal tract.

Participants will be randomly assigned, in a 1:1 ratio, to receive TEAS or Blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. TEAS will be performed in a series of time periods after operation. Time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. The participation of each patient is scheduled for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* All the patients signed the informed consent before treatment;
* Age ≥ 18 years old,American society of Anesthesiologists(ASA)grade are between I and III;
* Plan to perform elective colon and rectal tumor resection under general anesthesia;
* not involved in other clinical studies;
* no cognitive impairment, mental disorders,communication disorders.

Exclusion Criteria:

* Pregnancy, breast-feeding;
* The history of intestinal surgery;
* Test point skin injury, infection, allergies to tape;
* have undergone external enterostomy;
* Chief surgeon refuse to cooperate.
Insulin Pump vs Multiple Daily Injection on Cardiovascular Outcomes (ITALICO)

The aim of this study was to evaluate if the positive effects recorded on glycemic control with CSII were maintained on the long term compared to multi-daily injections (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation. This retrospective, observational trial evaluated 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 or 2 diabetes with prior treatment with MDI initiating CSII therapy with tubed insulin pumps
* patients type 1 or 2 diabetes with prior treatment with MDI continuing MDI
* patients attending the center for at least 8 years

Exclusion Criteria:

* patients not taking insulin
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
* Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
* Have locally advanced unresectable stage IIIA or IIIB NSCLC according to the eighth edition lung cancer stage classification
* Have at least 1 target lesion (primary lung lesion or involved lymph node\[s\]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and external beam radiation therapy (EBRT) as determined by the investigator at screening
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
* Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, major thromboembolic events, clinically significant ventricular arrhythmias or heart failure new york heart association functional classification class III to IV
* Another concurrent or prior primary malignancy (other than NSCLC) within the last 36 months at informed consent
* Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
* Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for procedures
A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.


Eligibility Criteria:
Inclusion Criteria:

* Females between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap test results.
* Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

* History of an abnormal cervical biopsy result
* History of a positive test for HPV; History of external genital/vaginal warts
* Currently a user of illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received a marketed HPV vaccine
* Currently enrolled in a clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)
Auditory Evoked Potentials and Experimental Pain

Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers. Electric nerve stimulation, cold and heat pain were used as pain models.

During the AEP monitoring, healthy volunteers were exposed to experimental pain. At study day 1: Firstly, single electric nerve stimulation and repetitive electric nerve stimulations causing temporal pain summation. The stimulations were given at 50, 75 and 100% of the thresholds for pain tolerance and temporal pain summation. Secondly, the volunteers were exposed to cold pain by use of two different Cold Pressor Tests (CPT) with water temperatures at 8 and 1 Celsius. All measurements were repeated after an hour to test reproducibility.

At study day 2: Brief Thermal Stimulation were used with two different temperatures and duration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 20 - 40 years old
Depression Care Management for Depressed Elders in China Primary Care

Using a randomized controlled design, the investigators will examine whether the DCM is an effective treatment for patients with late life depression in urban China. Our specific aims are: (1) to determine whether the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant medication according to the TG protocol. CMs monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.

* At the patient level: The investigator will gather information about age, gender, education, marital status, living conditions and satisfaction with their economic status, as well as systematic information on suicidal ideation,, psychopathology, medical health, cognitive function, quality of life and stigma and satisfaction for the treatment.
* At the provider level: the objective of research measures at the provider level is to gather social-demographic data such as age, gender, education, marital status, clinical experience among physicians in the participating PCCs as well as systematic information on their attitudes/knowledge regarding depression and clinical practices with the treatment guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old
* Community-dwelling residences
* Capable of independent communication
* Mini-Mental State Examination (MMSE) score ≥ 18

Exclusion Criteria:

* Incapable of giving written informed consent to this study
* Acute high suicide risk at baseline assessment
* Psychosis
N-3 PUFA and Rheumatoid Arthritis in Korea

The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline and receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.

Exclusion Criteria:

* Patients were excluded if they were pregnant, lactating, under the age of 18 or over age 80, taking supplements containing n-3 PUFA, white blood cell (WBC) ≤ 3.5 × 109/L, hemoglobin (Hb) ≤ 8.5 g/dL, platelet ≤ 100 × 109/L, creatinine ≥ 2.0 mg/dL, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of normal.
Breast Cancer and Chemo-amennorhea

Relation between chemotherapy and amennorhea


Eligibility Criteria:
Inclusion Criteria:

pre-menauposal breast cancer needed to be treat with chemotherapy -

Exclusion Criteria:

metastases menopausal

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Adapted Physical Activity Centre (in The) CITY for Elders Aged 70 and Over with At Least One Long Term Illness

Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.

The number of elders aged 70 and over and suffering of a chronic disease are increasing in our country. These patients are at risk of sarcopenia which can lead to an increasing risk of falls and hospitalization, loss of autonomy, and morbi-mortality. Twelve weeks adapted physical activity program can manage sarcopenia in elders. One of the difficulties to propose such a program to elders patients is the difficulty to reach the program center due to mobility deficiency. Our hypothesis is that proposing an adapted physical activity in a primary health care center, in the city of the patient, could help the participation.

Eligible patients addressed by their general practitioner will perform 4 months adapted physical activity program in the CAPA-CITY center (MSPU La Providence).

The inclusion will be realized by the sports doctor of CAPA-CITY. At M2, sport doctor and adapted physical activity teacher will meet the patient to readapt the program taking in count his particularity and wishes.

At M4 M6 and M12, an independent global evaluation will be realized by training nurse and clinical research associate.

Eligibility Criteria:
Inclusion Criteria:

* Elders aged 70 and over, with a chronic disease recognize as an Long Term Affection by the French social insurance.
* Living at home in Toulouse
* With a general practitioner working in Toulouse and agreed to participate to the CAPA-CITY70 program research

Exclusion Criteria:

* Elders living in nursing home
* Elders dependent for daily activity (score \< 5.5 Autonomy scale of Katz)
* Elders with dementia according to DSM V criteria
* Elders participating in another research project
* Contraindication for physical activity