cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be over the age of 18..
2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria:

1. Lack of consent.
2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
3. Type I or Type II Diabetes
4. Self-reported pregnancy
5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).
Medical Abortion up to 10 Weeks Gestation at Home

Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.

The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.

Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.

The study will be performed in five abortion clinics in Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Requesting and eligible for medical abortion
* Confirmed intrauterine pregnancy
* Gestational length no more than 70 days
* Hemoglobin over 100g/l

Exclusion Criteria:

* Anemia
* Contraindication to mifepristone (steroid-dependant cancer, porphyria)
* Breast feeding
* Advanced pregnancy (\>70 days)
* Known liver disease
* Bleeding disorder
* Arterial hypertension
Contact Lenses and Infiltrative Keratitis

To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.


Eligibility Criteria:
Inclusion Criteria:

* Soft contact lens wearers
* Healthy (control), or with history of infiltrative keratitis (case)
* Has a wearable pair of glasses
* Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism

Exclusion Criteria:

* Smoker
* Pregnant or nursing
* Systemic disease that would effect tear proteins
* Punctal plugs
* Use of eye drops in the last week
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure

Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.

The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.

Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.

Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* No periodontal surgical treatment in the previous 6 months on the involved sites

Exclusion Criteria:

* Smoking
* Patients with a pregnancy or lactation period
* Self-reported history of antibiotic medication within three months
* Absence of tooth in the area of donor site
Spinal Stimulation to Treat Low Back Pain

Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.

This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets


Eligibility Criteria:
Inclusion:

* Patients with one sided low back pain
* Failed standard conservative care including medications, physical therapy, and/or injections
* Pain greater than 6 months

Exclusion:

* Pregnancy
* Previous spine surgery
* Pain radiating beyond/below the knee
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration

The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration

The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Existing informed consent form signed and dated by study patient as well as investigator/authorized physician
* The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare his consent for participation in the clinical trial
* Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).
* Ongoing participation in an interventional clinical study during the preceding 30 days
* Previous participation in this study
* Pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or lactation period
* Patient is not able to give informed consent
Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients.

Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.

Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.

It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.

Eligibility Criteria:
Inclusion Criteria:

* Adult hemodialysis patients (≥18 years of age).
* Received dialysis for at least 6 months prior to study screening.
* Receive hemodialysis at least 3 times per week .

Exclusion Criteria:

* Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
* Participants with an allergy to any ingredients in the nutritional supplements.
* Significant edema and fluid overload.
* Hepatic patients.
S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.

OBJECTIVES:

* Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
* Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
* No known brain metastases

  * Negative brain imaging required for neurologic signs and symptoms

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)

Renal:

* Creatinine no greater than ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Must be able to swallow oral medication
* No AIDS syndrome or HIV-associated complex
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy
* No concurrent biologic therapy

Chemotherapy:

* No prior chemotherapy for advanced or metastatic gastric cancer
* At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 1 month since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

Under-representation of patients from racial/ethnic minority groups in cancer clinical trials is a major barrier to health equity. Black patients are significantly less likely to be enrolled in clinical trials compared with non-Hispanic White (White) patients although they carry a disproportionate burden of cancer mortality, the shortest survival rates, and are more likely to be diagnosed at later stages. Further, medical mistrust and lack of awareness and complexity of clinical trials are barriers that reduce the likelihood of clinical trial participation. The objective of this pilot study is to understand the effect of a culturally tailored decision aid (previously developed by our research team) on 1) medical mistrust, 2) patient knowledge about clinical trials, and 3) decision-making self-efficacy and determine the acceptability of the decision aid among Black patients currently or ever been diagnosed with cancer.

This study will be conducted online through Qualtrics.

Participants will answer pre-test survey questions, watch the culturally tailored decision aid video \[Fostering Opportunities in Research Using Marketing Strategies (FOR US)\] intervention, then answer post-intervention survey questions.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older
* Identify as Black/African- American
* Have Current or previous diagnosis of cancer
* Speak and understand English

Exclusion Criteria:

* Are younger than 18 years of age
* Do not identify as Black/African- American
* Do not have a current or previous diagnosis of cancer
* Are non - English-speaking
Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents 14-17 years of age with suicidal behavior and a borderline personality disorder for whom consent is obtained from parental authority,
* Affiliation to Social Security

Exclusion Criteria:

* Intellectual disability, psychopathy, delusional or concomitant major depression
Predictors of an Unfavorable Outcome in Patients With Heart Failure

The subject of the study is the factors of unfavorable prognosis in heart failure. We would like to identify independent variables associated with a bad prognosis of patients hospitalized for heart failure with a reduced vs. a mid range and preserved left ventricular ejection fraction based on specific predictive models. It is planned to create multifactorial models that can be used to predict prognosis for individual patients.

About 100 adult patients hospitalized for HF in the Department of Cardiology will be included in the study, including: the study group with HFrEF, HFmrEF and HFpEF. Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire. One year after inclusion in the study, a telephone interview will be conducted with patients. These will be questions about death, cardiovascular adverse events, hospitalization for heart failure and re-evaluation of the quality of life according to the KCCQ questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or older than 18 years
* HF (ischemic and non-ischemic) diagnosed according to the 2016 European Society of Cardiology (ESC) guidelines on HF \[1\], with HF class I, II or III according to the NYHA classification
* current HF hospitalization
* left ventricular ejection fraction (LVEF) documented in echocardiography during the current hospitalization

Exclusion Criteria:

* advanced liver failure (class B and C according to Child-Pugh score
* advanced chronic kidney disease (stages G4 and G5 according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) classification
* cerebrovascular accident (transient ischemic attack (TIA) / stroke / intracerebral haemorrhage) within 3 months prior to the hospitalization
* current pregnancy or lactation
* alcohol and drug abuse
* active autoimmune disease
* surgery or a serious injury within 1 months prior to the hospitalization
* other important medical condition that could have shortened the survival time during the study
* impaired cognitive status that compromises the understanding of the steps and completion of the study
The Effectiveness of Electroacupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain

Gynecological cancer is cancer that starts in the female reproductive organs. Pain in gynecological cancer can be caused by an underlying malignancy or surgical procedure as well as chronic pain associated with malignancy and sequelae of the therapy given. Gynecological cancer patients often experience moderate to severe pain and use higher levels of opioids than patients diagnosed with other cancers. More than two thirds of patients with advanced cancer experience severe pain and up to half of these patients report that their pain is not well controlled. This study aims to analyze the effectiveness of electroacupuncture plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (QLQ C-30 EORTC score) in patients with gynecological cancer pain compared to standard therapy alone.

This study was conducted using single blinded randomized control clinical trial, design in 58 patients diagnosed with gynecological cancer, aged 18 to 65 years, who experienced cancer pain, with VAS ≥ 4, pain caused by a tumor, before or while undergoing a therapeutic process (radiation therapy, chemotherapy, or post surgery), side effects or due to the toxicity of cancer treatment, willing to take part in this study and sign informed consent who were randomized into 2 groups, namely group I electroacupuncture with standard therapy and group 2 standard therapy, the acupuncture points used were LI4, PC6, ST36, SP6 and LR3, after the acupuncture needle was inserted, the needle was connected to the electrosimulator. The outputs assessed were pain intensity using the VAS, changes in analgesic dose, and quality of life with the EORTC QLQ C-30 questionnaire, which was assessed on the day before starting therapy, the first day, the second day, the third day, the fifth day and the seventh day.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 to 65 years old
* Gynecocal cancer with pain ≥ 4 acording Visual Analog scale and receive analgetic medicine
* The pain cause by

  1. direct from cancer
  2. Treatment proces surgery, radiotherapy, chemotherapy, paliatif treatment, supportive treatment
  3. Adverse reaction form treatment and intoxication

Exclusion Criteria:

* Emergency case patient with hemodynamic instable
* Patient with uncooperative behavior because ith serious psychological disorders, no currently undergoing psychiatric treatment, aggressive behavior, that not allowed for acupuncture.
* Patients with blood clotting disorders, with platelets \<50.000 and in neutropenic condition with \<1000 neutrophils.
* The patient has an allergy to stainless steel acupuncture needles. Wounds at the acupuncture point puncture sites, skin infections in the ears. On patients with eczema on the ears, external otitis or psoriasis.
* There is a tumor in the area that will be stabbed and stimulated in the stomach pregnant women, close to the heart, or in the area of the carotid sinus lymphedema, insertion into the prosthesis.
* Patients with heart rhythm disorders. The patient uses a pace maker.