cyrilzakka/clinical-trials huggingface dataset:
PD4PD:Partnered Dance for Parkinson Disease

Exercise is often noted as an important component in a comprehensive approach to the management of Parkinson disease (PD). Most studies of exercise have examined the effects of short-term interventions and have tested participants on their anti-Parkinson medications. As such, these studies have not been able to determine whether or not exercise may have a disease-modifying effect in people with PD. The investigators recent work has shown the potential benefits of dance as a form of exercise for individuals with PD, but, like previous work, has only examined short-term interventions. The investigators think that dance may be ideally suited for study over a longer period of time because dance incorporates many of the features recommended for inclusion in PD-specific exercise programs in a format that is known to be engaging and to enhance motivation to participate in healthful behaviors. As such, the investigators aim to determine both the short- and long-term effectiveness of a community-based dance program for individuals with Parkinson disease and to determine how physical function changes over time in individuals with PD who do not exercise as compared to those who exercise regularly. The investigators hypothesize that:

A) participation in dance will result in improved physical function, cognitive function, mood and quality of life in people with PD within 3 months,

B) additional improvements will be noted at 6 months as compared to 3 months,

C) improvements will be maintained at one year with continued, regular participation in a dance class,

D) those who do not exercise will show significant functional decline over a period of one year, a decline that will not be present in those who dance regularly.


Eligibility Criteria:
Inclusion Criteria:

* normal central and peripheral neurological function
* at least grade 4/5 strength and normal joint ranges of motion in both legs, - vision corrected to 20/40 or better
* able to walk independently for 10 feet with or without an assistive device, - normal somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch)
* no history of vestibular disease

Exclusion Criteria:

* serious medical problem
* evidence of abnormality other than PD-related changes on brain imaging (previously done for clinical evaluations-not part of this research)
* history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease
* history or evidence of orthopedic, muscular, or psychological problem
Electric Pace-pitched Hearing Achieves Natural Tonotopy

In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18y or older) and meeting the conventional Dutch CI criteria;
* Proficient speaker of Dutch language;
* Post-lingual onset of profound deafness (\> 4 years of age);
* Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor;
* Prepared to use study specific hearing aid (Phonak) for the duration of the study;
* Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA;
* Active participation in trial related procedures such as daily randomization and regular testing.

Exclusion Criteria:

* Physical or non-physical contraindications for MRI or CT imaging;
* Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;
* Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;
* Active participation in another prospective clinical trial;
* Pregnancy at time of imaging;
* Requirement for electric-acoustic activation prior to the first year follow-up;
* Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).
Anesthetic Efficacy in Irreversible Pulpitis

The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.

Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of irreversible pulpitis
* good health
* had at least 1 adjacent tooth plus a healthy canine

Exclusion Criteria:

* took medication could be interacting with any of the anesthetics used
Drug-Related Problems : Focus on Age and Diabetes

Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs.

DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including

* medication reconciliation,
* an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients.

In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP.

Translated with www.DeepL.com/Translator (free version)


Eligibility Criteria:
Inclusion criteria:

- Patients aged above 18 years old, admitted to the emergency department or hospital

Exclusion criteria:

* Patients presenting acute psychological disturbance
* Patients that did not agree to participate
Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.


Eligibility Criteria:
Inclusion criteria:

Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study

Exclusion Criteria:

* immobility of diabetic patients
* periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline
* pregnancy and lactation period
* Full Mouth Plaque Score (FMPS) \> 25%
* untreated periodontitis
* smoking \> 10 cigarettes/day
* insufficient crestal volume making an augmentation procedure necessary
* previously performed ridge augmentation procedure for a staged implant placement
* permanent medication potentially affecting blood perfusion rate and bone metabolism
TRIP-Patch vs the Rigiscan

In men without erectile problems, night time erections occur during the REM-sleep. For this study the current diagnostic test, the Rigiscan is compared, with the data from the TRIP-Patch during the night. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis. Eventually, to have a validated device, a patch in the size of a postage stamp, that easily measures erectile function at home. Furthermore the temperature on the outside of the thigh will be measured.

Background of the study: Erectile dysfunction (ED) is defined as the persistent or recurrent inability to attain and maintain an erection sufficient to perform sexual activity. ED has an effect on physical and psychosocial well-being. The current diagnostic test, the Rigiscan to measure night time erections, has a lot of disadvantages.

When an erection occurs and there is no inflow and outflow in the corpora cavernosa it is expected that the saturation will drop. As known with low flow priapism. From a study from Solnick, the mean skin temperature in younger male (19-33 years old) increases from 33,8°C to 36.2°C during arousal. A penile oximeter and temperature sensor was developed, to measure saturation and temperature of the penis during the night. The TRIP-Patch (Transdermal Rigidity assessment via Ischemia of the Penis) is expected to continuously measure saturation levels in the corpora cavernosa by real time monitoring with a photodiodes and LEDs and the sensor has a temperature logger.

Objective of the study: see above Study design: Observational study Study population: Healthy volunteers are asked to participate after informed consent. Age between 18 and 40 years. Both sensors and the Rigiscan will be placed at the same time, when 10 patients have night time erections with the Rigiscan, the study is complete.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without (a history of) erectile dysfunction
* Signed informed consent
* Male
* Between 18-40 year

Exclusion Criteria:

* Volunteers who are unwilling to sign written informed consent
* Volunteers with sickle cell anemia because this could affect the accuracy of the measurements
* Volunteers with erectile dysfunction
Visualization Tool for Investigation of Breast Lesions

Magnetic resonance imaging (MRI) is commonly used for the detection of breast lesions in genetically high-risk women due to its high sensitivity. As non-cancerous conditions including normal changes due to a woman's menstrual cycle may have the appearance of cancer on MR images, a biopsy (generally performed under ultrasound-guidance) of the suspicious mass is required for definitive diagnosis. However, only a limited percentage of MRI-visible lesions are also visible on ultrasound (US). Even if found, it is often unclear whether the lesion identified on US corresponds to the MRI-detected lesion in question. The investigators have developed a visualization tool to assist the visualization of MRI-detected lesions in US-guided procedures (e.g., biopsy). This tool provides a simultaneous display of the previously acquired MRI data alongside real-time US images. The investigators propose a pilot study to assess the usefulness of this tool in identifying MRI-detected lesions using real-time US-guidance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MRI-identified lesions that cannot be visualized under the second-look ultrasound examination, and who will undergo the recommended unilateral MRI follow-up.

Exclusion Criteria:

* US-visible lesion.
* Any contraindications to MRI (e.g., pacemakers, metal implants).
* Any contraindications to US imaging.
* Pregnancy.
* Claustrophobia.
* Inability to lie still for 45 minutes-1 hour.
* In excess of 250 pounds.
* Incapability to provide informed consent.
The Clean Air Study: HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes

Alaska Native children experience a high burden of respiratory disease, especially those in the Yukon-Kuskokwim (YK) Delta. Studies have shown that things like wood stove use, poor ventilation, and indoor tobacco smoke exposure can lead to poor indoor air quality inside the children's homes. This leads to more frequent and more severe respiratory infections in children.

In the Yukon-Kuskokwim (YK) Delta, it's common for homes to have exposure to woodstoves and tobacco use. Both of these activities affect indoor air quality in homes. We know that high efficiency particulate air (HEPA) purifiers can reduce particulate matter and make air quality better. One way that we measure air quality is through particulate matter (PM2.5). One of the few studies that looked at this in the YK Delta found that PM2.5 levels that were nearly twice as high as homes with woodstoves in other states. We believe it is important to reduce the PM2.5 in YK Delta homes. However, the few studies that looked at HEPA purifiers in rural Alaska did not include homes where smokers lived.

We know that breathing air with PM2.5 harms the lungs. We also know that HEPA filters can reduce PM2.5, which can mean reducing cough and wheeze in people with chronic lung conditions. We want to learn how HEPA filters work in homes with woodstoves or where a smoker lives, as it's likely these homes may have more PM2.5 than other homes. We expect that using HEPA filters will make the indoor air better and will mean decreased respiratory symptoms.

We plan to include 15 households with a child less than 5 years old in the family. Households that join will be asked to:

* Set up study equipment in their homes.
* Run the study equipment for 12 weeks and do a weekly report of child's respiratory symptoms by phone or text.
* Return the air-quality monitor equipment to the study team and keep the HEPA filters.

When a child has a pulmonology visit, the nurse will give the family a study flyer and invite them to learn more about the study. Participants that complete the informed consent process will be asked to: set up study equipment in their homes, operate the study equipment and do a weekly report of the child's respiratory symptoms for 12 weeks, and return the air monitoring equipment to the study team.

Eligibility Criteria:
Inclusion Criteria:

* Alaska Native participants residing in homes where woodstoves are used for heat or a smoker resides in the home.

Exclusion Criteria:

* Plan to move homes during the study period.
* Using HEPA air purifiers (other than the ones provided by the study).
Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique

This study will use the euglycemic clamp technique to evaluate insulin absorption when insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area of normal tissue.

The use of insulin to manage diabetes can cause changes to the skin at sites where insulin is administered. These changes may be felt as lumps under the skin. Insulin injected into these areas may not work as well leading to needing increasing doses of insulin to control blood glucose levels. Hypoglycemia can occur when insulin is injected into normal areas. Previous studies have found that these lipohypertrophic areas can be seen on ultrasound before they can be felt. The Investigators will be using the euglycemic clamp techique to evaluate insulin absorption to see whether tissue with lumps that cannot be felt but are seen on ultrasound affect how insulin is absorbed.

Eligibility Criteria:
Inclusion Criteria:

* Participated in Glycemic Variability study
* Type 2 Diabetes for at least 2 years
* Currently using insulin to manage diabetes
* Have used insulin to manage diabetes for at least 2 years
* Age 19 or older
* BMI \< 30 kg/m2
* Confirmed areas of subclinical lipohypertrophic adipose tissue lesions via ultrasound

Exclusion Criteria:

* Taking other injectable medications (eg liraglutide/Victoza
* Taking systemic steroids (ie prednisone)
* Severe renal insufficiency (eGFR \< 30 ml/min/1.73 m2
* Hypoglycemic unawareness
* Current pregnancy
* Not fluent in speaking and writing English (unless accompanied by a translator)
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer

The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.

Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery. Before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cross arrangement. Two drainage tubes at the pelvic floor exit through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen, thus completing the tube placement.

Within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.

HIPEC is not performed postoperative. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 and ≤70 years;
2. Male or nonpregnant female;
3. Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system);
4. No distant metastasis, suitable for D2 lymph node dissection;
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
6. No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
7. Written informed consent given before any study-related procedures;

Exclusion Criteria:

1. Other cancers within the past 5 years;
2. Distant metastasis (M1) found during surgery;
3. ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status \>2;
4. Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery;
5. A history of severe mental illness;
6. History of taking steroid medications;
7. Receiving other chemotherapy, radiotherapy, or immunotherapy;
8. Lack of written informed consent;
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse

Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.


Eligibility Criteria:
Inclusion Criteria: female gender, age 13-18, and a primary DSM-IV-TR diagnosis of chronic or subthreshold PTSD related to sexual assault

Exclusion Criteria: current suicidal ideation with intent, uncontrolled bipolar disorder, schizophrenia, other thought disorders, or conduct disorder, the presence of a pervasive developmental disorder, initiation of treatment with psychotropic medication within the previous 12 weeks, and current inpatient psychiatric treatment
Efficacy and Safety of SPARC0921 in Subjects With Spasticity

The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 years and older
* Able and willing to comply with the protocol, including availability for a scheduled clinic visits
* Willingness and giving of written informed consent

Exclusion Criteria:

* In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
* Concomitant neurologic conditions causing spasticity
* Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
* Unable to comply with study procedures in the opinion of the investigator
Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus

Hypothesis: the diabetes-specific formula Nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.

This study is an open label, randomized controlled cross-over study

Research objectives:

1. To study the efficacy of diabetes-specific formula (Nutren Diabetes) in comparison with an isocaloric diet in the aspect of postprandial blood glucose and insulin response (baseline, 30, 60 and 120 minute).
2. To study the safety and tolerance of a diabetes-specific formula compared with an isocaloric diet in patients with type 2 diabetes mellitus

Statistical analysis method

1. Descriptive statistics: categorical data will be summarized as number and percentage, continuous data with normal distribution will be presented as means and standard deviations, and continuous data with non-normal distribution will be summarized as median, minimum and maximum.
2. Inferential statistics: Repeated Measure ANOVA from analyzing the difference of means from measuring fasting glucose and insulin more than two times.
3. Inferential statistics: Paired T-Test or Wilcoxon Matched pairs Signed Rank Test derived by analyzing the comparison between the means of two dependent groups.
4. Report of the difference between two categories by the difference of means with 95% Confidence Interval
5. Number of participant (subjects) and criteria for participation 30 participants by calculation formula of Frison and Pocock (1992) with STATA program.

Eligibility Criteria:
Inclusion Criteria:

* DM type 2, HbA1C \< 9% FPG \< 180 mg/dl
* Aged between 18- 70 years.
* Participants must have stable body weight (+/- not over 5%) for the past six months.
* Participants must control their diabetes by diet control or taking diabetes medicine without medicine dose adjustment during the period of the research.
* Participants are willing to participate in the research and sign written consent form.

Exclusion Criteria:

* Participants receive insulin hormone and GPL-1 agonist injection.
* GFR \< 30 ml/min/1.73 m2
* Participants have decompensated liver cirrhosis or alcoholism or drug abuse record.
* Participants have record of allergy to any ingredients in diabetes-specific formula,soybean milk or bologna and mayonnaise sandwich.
* Participants decline to participate