cyrilzakka/clinical-trials huggingface dataset:
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytologic diagnosis of esophageal carcinoma
* ECOG performance status 0-1
* Age:70-85 years
* Joined the study voluntarily and signed informed consent form
* Patients must not have received any prior anticancer therapy
* Stage Ⅰ-ⅣB（AJCC 2009）
* Target lesions can be measured according to RECIST criteria
* No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN

Exclusion Criteria:

* Multiple carcinomas of the esophagus,
* Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
* Metastatic disease (M1b),
* A primary tumor that extended to within 2 cm of the gastroesophageal junction,
* Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
* history of a second malignancy other than nonmelanoma skin cancer
Extended-release vs Immediate-release Metformin in PCOS Women

The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.


Eligibility Criteria:
Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* past history of cardiovascular diseases
* past history of gastro-intestinal diseases
* significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
* neoplasms.
Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy

This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device called Body Composition Monitor (BCM) which measures the body composition (i.e. the water content of the body).

Specifically, the investigators will evaluate the use of BCM for correct detection of intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we will test the change over time of the volunteers´ volume status after an intravenous fluid therapy.

Technically assisted assessment of volume status may be useful to direct fluid administration.

As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine fluid status in volunteers after an intravenous fluid therapy.

The correlation of infused fluid and change of the fluid status measured with Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.

Using a three-compartment physiologic tissue model, BCM determine total body fluid volume (TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz through the entire patient via 4 electrodes placed on the wrist and ankle.

Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After randomisation into one of two treatments the volunteer will receive either an iv isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour or no fluid therapy. At the second study day the volunteer will obtain the opposite treatment.

We will perform BCM measurements every 10 minutes before, during and after the treatment for 6 hours or until the BCM results return to baseline. The results are stored on a BCM patient card automatically.

The main objective of this study is to detect the administered iv fluid in the extracellular compartment respectively in FO, TBV and ICV.

Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the iv therapy at the study day "Fluid Therapy".

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged between 18 and 50 years
* BMI \< 30 kg/m2
* Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study

Exclusion Criteria:

* Implanted pacemaker or defibrillator
* Limb amputation identified by physical examination
* Known allergy or hypersensitivity to Elo-Mel
* Abnormalities in Blood pressure (Hypotension with a systolic BP \< 90 mmHg and hypertension with a systolic BP \> 160 mmHg) after 5 min resting
* Cardiac insufficiency (NYHA≥ 2)
* Renal insufficiency (GFR ≤ 60 ml/min)
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)

The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).

The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.


Eligibility Criteria:
Key Inclusion Criteria:

* Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorders.
* Evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms).
* Participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to Baseline/Day 1, including concomitant psychotropic medication. Doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted.
* SCI-PANSS: No more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. PANSS, positive symptom items P1, P3, P5, P6, P7); or unusual thought content (G9); and no more than a moderate rating (score ≤4) on conceptual disorganization (P2).

Key Exclusion Criteria:

* Participation in a trial using any component or version of the MATRICS Consensus Cognitive Battery (MCCB) or the University of California, San Diego (UCSD) Performance-Based Skills Assessment test within the previous 6 months.
* Participation in cognitive remediation therapy within 6 months prior to randomization.
* Screening MCCB Working Memory Domain T-score ≥60.
* Current DSM-5 diagnosis of schizoaffective disorder on the MINI 7.0.2 for Psychotic Disorders.
* Current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the MINI 7.0.2 for Psychotic Disorders.
* Lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the MINI 7.0.2 for Psychotic Disorders.
* Meets the DSM-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the MINI 7.0.2 for Psychotic Disorders interview.
* DSM-5 diagnosis of Intellectual Disability (intellectual developmental disorder).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Low Literacy CVD Nutrition Education

To develop and evaluate a nutrition education program to reduce cardiovascular disease risk in persons with low literacy skills.

BACKGROUND:

The setting for the study was the Minnesota Extension Service's Expanded Food and Nutrition Education Program (EFNEP), which was a U.S. Department of Agriculture-funded program to improve the nutrition knowledge and behavior of low-income individuals who were responsible for food preparation. The emphasis of EFNEP was on obtaining adequate and nutritious foods, and not on dietary behaviors for the prevention of chronic disease. Because a large proportion of this population had no more than an 8th grade education (30.9 percent nationally), EFNEP provided access to individuals with low literacy skills and a need for nutrition education for disease prevention. For example, a pilot study indicated that 34 of 42 respondents had never had their blood cholesterol level checked.

The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy Skills". The initiative originated within the Prevention and Demonstration Branch of the DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council, and released in July 1990.

DESIGN NARRATIVE:

The study developed education strategies using focus groups of both the Minnesota Extension Service's Expanded Food and Nutrition Education Program (EFNEP) program participants and the EFNEP paraprofessionals who delivered the program. The intent of the focus groups was to identify concerns, interests, barriers, and perceived needs for nutrition education for cardiovascular disease prevention. This information was used to develop effective education strategies that addressed the needs of the study participants, while accomplishing the study goal of effecting dietary change (specifically, decrease in dietary fat and cholesterol intake) for cardiovascular disease risk reduction.

The effectiveness of the nutrition education program was evaluated in a randomized trial, with pre- and post-intervention measures of dietary fat intake and plasma total and HDL cholesterol as outcome measures. The study was conducted in Hennepin, Ramsey and Dakota Counties, which had a total adult EFNEP enrollment of about 1,842 people. Because EFNEP enrollment was predominantly female (94 percent), this study was limited to adult women, age 18 or older. All 22 EFNEP paraprofessionals in these counties were randomized to intervention and control group. Randomization was at the level of paraprofessional to simplify program delivery and to minimize contamination between intervention and control groups. The differential changes in fat intake and plasma cholesterol level between the intervention and control groups were estimated using analysis of covariance, adjusting for within paraprofessional correlation and other potential confounders.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Reducing Emergency Department Utilization With an After Visit Summary Nudge Toward Alternative Care Options

Decreasing utilization of the Emergency Department (ED) is a priority for the system. Often, ED visits can be avoided if patients contact Geisinger first to get appropriate direction for their concern or are otherwise better informed about reasons to visit the ED vs. urgent care or primary care facilities. The study team is working to reduce ED utilization by including additional information in adult outpatient After Visit Summaries (AVSs). The study will involve will involve A/B testing different AVS versions, including 1) a version that encourages patients to contact Geisinger via different contact methods, 2) a version that includes a map to the patient's closest ConvenientCare location and accompanying information about ConvenientCare, and 3) a version that includes a self-triage guide. A control group will receive the current standard AVS. Analysis results will be assessed to determine which version is most effective at reducing ED use.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Has a Geisinger Primary Care Physician assigned
* Completes an outpatient office visit or telemedicine appointment at Geisinger

Exclusion Criteria:

* The AVS was not printed according to the EHR, and the patient does not have an active MyGeisinger patient portal account, so they do not have a way to view the AVS
Genetic Studies of Strabismus, Nystagmus, and Associated Disorders

Strabismus (misalignment of the eyes) often runs in families. In this study, the investigators are looking for genetic variants associated with strabismus and nystagmus. Three types of subects will be enrolled: (1) Families with at least 3 members with strabismus, (2) individuals with infantile esotropia and their parents and siblings, and (3) individuals with infantile nystagmus and their parents. Whole exome and/or whole genome sequencing will be used to identify genetic variants shared by family members with strabismus and to identify genetic causes of nystagmus.


Eligibility Criteria:
Inclusion Criteria:

- Member of a family with at least 3 biological relatives with strabismus. (Both affected and non-affected family members will be enrolled).

OR

- Member of a family with at least 1 individual with infantile esotropia. (Both affected and non-affected family members will be enrolled).

OR

- Member of a family with at least 1 individual with infantile nystagmus. (Both affected and non-affected family members will be enrolled).

Exclusion Criteria:

* paralytic strabismus in affected family members
RMN Versus Manual Epicardial Retrospective PMCF

Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.

Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
* Index procedure was conducted between July 1, 2013-present date.

Exclusion Criteria:

* NA, all subjects who meet inclusion criteria may be enrolled.
Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer

In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. However, no research has specifically examined their effect on postoperative pain. The aim of this study is to investigate the impact of using a curcumin solution in combination with photodynamic therapy as the final irrigation solution on postoperative pain.

Fifty patients were randomly assigned to two groups using a web-based program, according to the selected final irrigation procedure: curcumin-photodynamic therapy or a control group (routine root canal final irrigation with NaOCl and EDTA). The teeth will be isolated with a rubber dam, and access cavities will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will then be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.

Eligibility Criteria:
Inclusion Criteria:

* healthy patients with aged between 18-60.
* Incisor, canine, and premolar teeth that had previously undergone root canal treatment
* Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
* teeth with only 1 root canal
* the patients had not used any antibiotics for 3 months before treatment

Exclusion Criteria:

* the presence of a root fracture
* teeth with any swelling
* ankyloses,
* periodontal pockets deeper than 4 mm.
* teeth which a rubber dam could not be performed
* patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Multiomics-based Prediction Model for GDM

A prospective cohort study was conducted to :1. explore the relative biomarkers of related with the occurence and development; 2. develop a multiotimics prediction model for GDM.

Gestational diabetes mellitus (GDM) is one of the most complications during pregnancy and it is associated with many adverse outcomes especially when the pregnant women can't control blood glucose well. With economy develop rapidly, the occurence of GDM is about 15-20%. Recently, the research on GDM has gone into the molecular level, which is beneficial to diagnosis and treatment on GDM. Besides, the cost of hospitalization and treatment for adverse outcomes caused by GDM have caused a certain burden to pregnant women, their families and the whole country. Lifestyle management has the first-line for treatment on GDM, however, the situation of self-management on GDM isn't satisfactory. Therefore, our study aims to explore a model to predict GDM in advance and reduce the adverse outcomes and economy associated with GDM.

The study plan to enroll 60 participants with hisk-risk of GDM and 40 normal participants. They are required sign the inform consent after deciding to participate the research. Furthermore, during early pregnancy (8-13 weeks), middle pregnancy (24-27 3 weeks) and late pregnancy (32-36 weeks), 6-8 weeks after delivery, blood, feces, urine, saliva samples were collected, and continuous blood glucose monitoring system were equipped, human component testing was performed. Follow up was performed to collect the first stool sample of the mother after delivery and faecal samples from the first to the fifth time after birth (the first five times within one week after birth, including hospitalization and discharge) .

Eligibility Criteria:
Inclusion Criteria:

All of following conditions must be met:

* The range of pregnant week is between 8 to 13+6 weeks;
* The range of age is between 20 to 45 years;
* Pregnancy naturally and singleton pregnancy;
* According to the 2020 GDM high-risk population scoring model, those who gets equal to or larger than 80 scores will be assigned to high-risk group and equal to or smaller than 20 scores to low-risk group;

Exclusion Criteria:

Meeting one of the following conditions will be excluded:

* Smoking or drinking alcohols;
* Pregnant women who used antibiotics before 1 month enrollment;
* Combined with Chronic hepatitis, nephritis, chronic gastritis, gastric ulcer, chronic colitis, hyperthyroidism, hypothyroidism (except subclinical hypothyroidism) and blood diseases before pregnancy;
* Pregnant women who has a long-term medication history;
* Those who reject signing the inform consent;
* Those who has participated other clinical trail in the same period
Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial

The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.

In a cluster randomized trial the investigators will explore the efficacy of up to three outreach visits by specially trained GPs. Efficacy data are obtained by means of questionnaires at regional databases.

Eligibility Criteria:
Inclusion Criteria:

General Practices working in the capital region in Denmark

Exclusion Criteria:

General Practices where the facilitator works.
Dry Needling Treatment for Knee Osteoarthritis

The population affected by degenerative knee arthritis is very large. The investigator performed dry needle (DN) treatments with acupuncture needles. This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of dry needle therapy on patellar pain in patients with degenerative arthritis.

The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.

The investigator performed dry needle (DN) treatments with acupuncture needles. Stimulating the effected muscle, the investigator move the needle forward and backward several times. Muscle twitch may occur by our procedure. The pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.

For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of dry needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.

This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of dry needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lequesnes index, Gait speed test and the Muscle Tension Changes in the Lower Extremities.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers who are older than 50 years old and can cooperate with the experiment
2. Established diagnosis of unilateral or bilateral degenerative knee arthritis.
3. There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.

Exclusion Criteria:

1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
2. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
3. Have received knee surgery.
4. People with central or peripheral nerve disease.
5. Cognitive impairment, unable to cooperate with the experimenter.
6. Patients currently receiving other treatments for knee osteoarthritis