cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Magnetic Therapy on Pain Intensity

Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet.

The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects.

Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet. The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects.

A randomized, double blind, controlled trial is proposed. Patients from 8 years old and older subjected to a variety of surgical procedures with pain of intensity at least 5/10 will be randomized into two groups: Magnetic therapy or Placebo.

The devices will be placed around the surgical wound for 2 hours. Every ten minutes, patients will rate their pain intensity on a 0-10 numerical rating scale, and morphine will be administered until pain intensity is ≤ 4/10. Pain intensity will be the primary outcome. Opioid requirements and opioid side effects will be secondary outcomes.

To detect a difference of 1 unit (from 0 to 10) between the groups with 80% power, assuming that the baseline pain intensity is 7.9 ± 2.0, we estimated the need for 70 patients per group.

We will use an intention-to-treat analysis. To analyze the effect of the treatment on pain intensity, an analysis of repeated measures using generalized estimating equations will be used. The proportion of subjects in each group who exhibit 50% or more pain relief one hour after application of the magnetic devices and the number needed to treat will also be calculated. To analyze the effect of the treatment on opioid requirements, a difference in morphine requirements between groups two hours after placement of the magnets will be estimated. To analyze the effect of the treatment on opioid side effects, a variable that summarizes the presence of any side effect two hours after the placement of the magnets will be created, and the absolute risk difference for developing any side effect will be estimated. Ninety five percent confidence intervals will be reported.

This proposal would contribute substantially to the complementary medicine field, not only because of its scientific rigor, but also because the pain model that it evaluates strengthens the validity of the results.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized or ambulatory patients 8 years old or older subjected to surgical procedures under general anesthesia, who reported at least moderate pain.

Exclusion Criteria:

* Subjects with surgeries longer than 3 hours
* Multiple surgical wounds
* Back or craniofacial surgeries, or surgeries which required cast placement, bulky dressing or the implantation of metallic devices.
* Subjects who did not understand the pain scales employed
Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021

The aim of our study is to analyze mortality and sequelae of subarachnoid hemorrhage of aneurysmal origin in hospitalized patients in Martinique. Predictive factors of poor prognosis will also be analyzed.

Subarachnoid hemorrhage is an uncommon pathology in the general population, with a worldwide incidence of 9 per 100,000 people/year, but with a non-negligible risk of sequelae in terms of impairments, activity limitations and participation restrictions of around 30%. Mortality remains high at 40%, despite increasingly specialized care.

In addition, there are a number of objective, rapid assessment scores for autonomy and impairments, notably the modified Rankin score, which is not specific to subarachnoid hemorrhage, but which enables the study of patients' perceived quality of life. Certain factors predictive of bad patient outcome are known in the literature, but have been little studied in the population of Martinique.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients,
* Admitted to University Hospital of Martinique with subarachnoid hemorrhage of aneurysmal origin between 01/01/2013 and 31/12/2021,
* Informed patient/next-of-kin/treating physician consent for research participation.

Exclusion Criteria:

* Other causes of subarachnoid hemorrhage of non-aneurysmal origin (traumatic, arteriovenous malformation, cerebral tumor, cerebral thrombophlebitis).
Effects of Stimulant Dependence on Human Striatal Dopamine System - 15

The purpose of this study is to determine whether DAT availability, assessed by WIN binding, in the striatum is altered in cocaine or methamphetamine dependence. To determine whether DA synthesis capacity, assessed by FDOPA uptake, in the striatum is altered in Coc or Meth dependence. To determine whether the PET tracers, WIN or FDOPA, will differentiate Meth induced alterations from those induced by Coc use. To determine whether the PET characterization of striatal alterations observed at 3-5 days since last drug use persists at least 3 months after last drug use.

4-5 Day inpatient study. Participant will have scanned pictures (MRI \& PET scans) taken of their brain after being injected with a small amount of WIN, a radioactive substance. Participants give daily urine samples and fill out health related questionnaires. It is important to determine whether the alterations characterized within one week of last drug use persist over a longer time period. Based on results of the studies from aims 1 \& 2, we will decide which of the 2 probes, WIN or FDOPA-PET is the more sensitive index of stimulant-dependency-induced changes.

Eligibility Criteria:
Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for methamphetamine and nicotine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease

The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.

There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Ileocolic disease with an indication for ileocecal resection
2. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
3. All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
4. Ability to comply with protocol.
5. Competent and able to provide written informed consent.
6. Patient must have been discussed in the local MDT

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Inability to give informed consent.
2. patients less than 16 years of age.
3. Patients undergoing repeated ileocolic resection.
4. Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
5. History of cancer \< 5 years which might influence patients prognosis
6. Emergent operation.
7. Pregnant or breast feeding.
8. Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement

The purpose of this study is to learn about discussion between clinicians and their patients related to lung screening. Survey answers will be collected from both clinicians and their patients.


Eligibility Criteria:
Inclusion Criteria:

CLINICIANS:

* Clinician (physician, nurse practitioner, or physician assistant)
* Practicing in a KPWA primary care clinic
* Having a patient panel with \>/= 10 lung cancer screening eligible patients

PATIENTS (Quantitative Phase):

* Age 55-80 years
* \>/= 30 pack-year tobacco smoking history
* Current smoker or former smoker who has quit within the past 15 years
* Documented SDM lung cancer screening discussion during a recent clinic visit

Exclusion Criteria:

PATIENTS:

* Significant comorbidities (Charlson Comorbidity Index \>/=3)
* Lung cancer diagnosis
Low-Carb Versus Mediterranean Diet in PCOS

This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.

The study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . Women with PCOS are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a Mediterranean diet. The adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.
* Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):

  * signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)
  * signs of chronic anovulation
  * ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.

Exclusion Criteria:

* The presence of hyperprolactinemia
* Cushing's syndrome
* Ongenital hyperplasia of the adrenal cortex
* Hypothyroidism
* Androgen-producing tumors
* Regular use of drugs and dietary supplements that affect the function of the ovaries
* Adrenal glands
* Metabolism of carbohydrates
* Lipids
* Microbiota composition during the 2 months preceding the study
* Pregnancy
* Lactation
* Significant comorbidities
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 65-85 years;
2. Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
3. G8 score ≤14;
4. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
5. Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
6. Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
7. Date of surgery ≥2 weeks from baseline (T0) assessment;
8. Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
9. All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.

Exclusion Criteria:

1. Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
2. End-stage cardiac insufficiency (LVEF\<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
3. Cerebral bleeding or infarction (within 6 months);
4. Patients with recurrent infection diseases or serious concomitant disease;
5. Patients who require synchronous surgery due to other illness;
6. Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
7. Patients who are participating in any other clinical trials.
Capsule Endoscopy in Obscure GI Bleeding

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted. Patients randomized 1:1.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Obscure overt GI bleeding
3. No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding

Exclusion Criteria:

1. Known or suspected swallowing disorders
2. Known or suspected small bowel obstruction
3. Multiple comorbidities precluding surgery
4. Patients with implantable electromagnetic devices
5. Pregnant women
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease


Eligibility Criteria:
Inclusion Criteria:

* Had a known history of dry eye disease
* Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

Exclusion Criteria:

* History of intraocular inflammation in either eye
* Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
* Uncontrolled glaucoma or is on medications to treat glaucoma
* History of IOP spikes in either eye
* Active epiphora
Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients

The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.

Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
* received secondary ABG at Chang Gung Craniofacial Center
* received team managements based on our current treatment protocol for cleft lip and palate

Exclusion Criteria:

* syndromic cleft
* patients with failed grafted tissue
Glucose Pattern in Infertile Women Receiving Assisted Reproduction Using Continuous Glucose Monitoring

No studies have been seen on glucose variation during medication for assisted reproduction. The aim of this study is to continuously observe glucose variation during assisted reproduction treatment using continuous glucose monitoring (CGM), and to further explore whether glucose variation will affect the outcomes related to assisted reproduction.

Infertility is a growing global health concern and affects approximately 20% of couples of reproductive age. As a result, the use of assisted reproductive technologies (ART) is becoming more prevalent. This study could serve as a basis for the interpretation of glucose levels with respect to these people undergoing ART regimen. Moreover, the success rate of ART still needs to be further improved. Key challenges include optimizing the hormonal components of ART regimens and determining the ideal treatment duration. This study might provide insights into the potential benefits of monitoring glucose levels at specific points during ART cycles (which is not usually performed in routine practice) and help clinicians tailor ART regimen to minimize glucose variation, ultimately improving clinical pregnancy and live birth rates. Additionally, the findings might support integrating CGM into the clinical practice of ART, enhancing individualized patient care.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent and voluntary participation in this study;
2. Age ≥ 18 years and ≤40 years old;
3. Infertile patients who will undergo their first or second cycle of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) at the study center;
4. The chosen ovulation promotion regimens is the GnRH antagonist regimen/progesterone-promoting ovulation under hyperprogesterone state (PPOS) regimen.

Exclusion Criteria:

1. Recent infections (excluding viral infections of the reproductive system such as HPV);
2. Recent glucocorticoid treatment or chemotherapy;
3. Clinical conditions affecting the outcome of assisted reproduction, including repeated implantation failure, recurrent spontaneous abortion, history of unilateral oophorectomy, uterine malformations, and parental karyotype abnormalities;
4. Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
Postoperative Intensive Care Surveillance

Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).

The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* multiple surgery
* age less than 18
Improving Bowel Cleansing With a Smart Phone Application

Getting ready for a colonoscopy is difficult and involves a lot of steps. The information given to patients is very important to adherence to treatment. The investigators have created a novel smart phone application (SPA) aimed to increased bowel preparation quality and patient satisfaction, using different educational tools.

Background: Getting ready for a colonoscopy is difficult and involves a lot of steps. The information given to patients is very important to adherence to treatment. The investigators have created a novel smart phone application (SPA) aimed to increased bowel preparation quality and patient satisfaction, using different educational tools.

Methods: The investigators have performed a prospective, endoscopist-blinded, randomized, controlled trial. The investigators have enrolled 260 outpatients owners of a smartphone. Patients were randomly allocated to two different protocols: instructions provided by SPA (SPA group; n=108) or written instructions with visual aids (control group; n=152). All procedures were performed in afternoon time and patients received the same purgative regimen (2-L PEG solution plus ascorbic acid), in a full-dose same-day regimen. The day before colonoscopy (Baseline), patients initiated low fiber diet. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. The effect of protocol on patient satisfaction was assessed with a specific questionnaire at time of the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Elective colonoscopy
* Owners of a smartphone

Exclusion Criteria:

* No owners of a smartphone