cyrilzakka/clinical-trials huggingface dataset:
Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke

Our research aims to analyze and compare the improvement of various indicators of gait disorders and balance function before and after dynamic hot spring hydrotherapy and conventional exercise intervention, and clarify the therapeutic effect of dynamic hot spring hydrotherapy on gait disorders and balance function in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cerebral infarction or cerebral hemorrhage who meet the diagnostic criteria for stroke of the Chinese Medical Association; (2) Initial stroke\<6 months, or last stroke event\>6 months; (3) Age\>=18 years old,\<85 years old (increased risk of VCI over 85 years old); (4) NIHSS\>4, NIHSS\<26 points; (5) MRS score\>=2 points; (6) complete CT or MRI; (7) No serious neurological or mental illness; Unconscious disorders, able to cooperate with relevant treatments; No severe cognitive impairment (MMSE\>=15 points); (8) Berg Balance Scale\>40 points; (9) The patient or family member signs an informed consent form.

Exclusion Criteria:

* (1) Concurrent major diseases, such as heart, lung, liver, kidney and other organ diseases or failure; (2) There are contraindications for hydrotherapy such as acute infectious diseases, open skin wounds, and severe epilepsy; (3) There are other clinical issues that may affect the assessment results, such as low vision, fractures, vestibular diseases, etc; (4) There are other neurological disorders, such as multiple sclerosis, Parkinson's disease, etc; (5) Serious mental and psychological problems exist; (6) Malignant tumor patients; (7) Early pregnancy or high-risk pregnancy; (8) Serious alcohol abusers; (9) Patients with active bleeding, such as gastrointestinal bleeding, nosebleeds, and excessive menstruation.
Burden of Disease and Living Situation in Desmoid Patients

The main aim of the study is to assess the situation and quality of life of desmoid patients. Impaired areas of quality of life and the associated factors are to be identified. The survey is planned as a cross-sectional study (patient survey).

Prevalent and incident desmoid patients will be identified at the University Hospital Mannheim and checked for eligibility. Quality of life and patient-reported data are collected by means of written questionnaires. Medical data is collected from patient files in the clinics. The aim is to include 100 patients. Descriptive analyses of the variables collected and regression models are planned as statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Desmoid diagnosis (primary neoplasia, all stages)
* Age ≥18 years at diagnosis

Exclusion Criteria:

* Inability to complete a structured questionnaire (insufficient language skills; dementia)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy as assessed by medical history and safety evaluations performed at screening
* Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg
* Must be willing and able to abide by the prohibitions and restrictions of the study, including requirements for contraception
* Women must not be of childbearing potential by either being postmenapausal or permanently sterilized
* Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity
* Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements

Exclusion Criteria:

* Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation
* Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years
* Man who has a pregnant female partner
* Woman who is breastfeeding
* Is participating or has participated within the last 3 months in a study with an investigational drug or medical device
* Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease
* Drug or alcohol abuse within the last 5 years, nicotine use within the last 3 months, or tests positive for alcohol, drugs of abuse, or nicotine
* Routinely consumes an excessive amount of caffeine
Advance Care Planning With Older Patients Who Have End-stage Kidney Disease

This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.

Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.

Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.

However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.

To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.

Eligibility Criteria:
Inclusion Criteria:

* Attending the renal units taking part in the study
* Receiving renal replacement therapy
* Capacity to understand, retain, and weigh the necessary information and communicate their decisions
* Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.

Exclusion Criteria:

* Expected to die in the next three months
Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury

It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding:

1. The success rate after initial intervention.
2. The need for urethroplasty in the failed realignment group and cystostomy group.
3. The success rate of urethroplasty in the failed realignment group and cystostomy group.


Eligibility Criteria:
Inclusion Criteria:

* Male children less than 18 years presenting with pelvic fracture urethral injury

Exclusion Criteria:

* Associated bladder neck injury.
* Associated rectal injury.
* Late presentation \>2weeks since trauma.
* History of previous urethral intervention.
Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).

This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients

For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, some criticize ERP arguing that patients are asked to return home too early, while they have not recovered a satisfactory autonomy. Few studies have investigated the comfort and quality of home life of patients who have had ERP. We recently conducted a retrospective study to evaluate this quality of life. It turns out that patients report little postoperative pain, a sufficient degree of autonomy at home, and a high general satisfaction score (\> 8.5 on a numerical scale of 0 to 10). However dietary and digestive difficulties were described by about one third of the patients questioned. \[6\] Others have also reported a caloric-protein deficit during the immediate postoperative period after colorectal surgery, up to the 7th day in some of their patients \[7\].

Aim of the study. The aim of this study is to assess caloric-protein intake up to one month after colorectal surgery within ERP.

General description. This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients.

Eligibility Criteria:
Inclusion Criteria:

* any patient scheduled for colorectal surgery within an ERP at CHU Liège

Exclusion Criteria:

* unable to answer the survey (cognitive disorders, bad knowledge of the French language)
* closure of loop ileostomy
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution

This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.


Eligibility Criteria:
Inclusion Criteria:

Patients are eligible for the study if all of the following apply:

* Are aged 35 years or above
* Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component \>=80%) pulmonary nodule that:

  * is not fully calcified
  * Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
* Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):

  * Is of a type that meets VNC instructions for use
  * Comprises at least one full-inspiration breath-hold scans without a high degree of contrast media and does not exhibit quality issues (e.g., motion artefacts)

Exclusion Criteria:

Patients will be excluded from the study if any of the following apply:

* Have received a diagnosis for cancer in the last 5 years
* Have thoracic implants that impact the image appearance of the nodule
* Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)
* Have one or more additional nodules where any of the following applies:

  * Are already undergoing follow-up according to pulmonary nodule management standard care
  * Pure ground glass opacity (GGO) of \>=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
  * \>30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
Emergency Department (ED) Self-Monitoring Pilot COVID-19

This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one).

The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.


Eligibility Criteria:
Inclusion Criteria:

* Reported symptoms of viral illness during ED encounter
* Tested for SARS-CoV-2 (COVID-19) during ED encounter
* Discharged home from the Emergency Department

Exclusion Criteria:

* Prisoners
* Residents of congregate living facilities who are already being monitored
* Baseline oxygen requirement
* Patients whose primary goals of care are palliative
* Pregnant women
Experimental Study of Detection an Intentional Performance Degradation in Grip Strength

In this study, the detection of the feigning weakness in grip strength is measured using different grip strength testing instruments. Patients with injury of the upper limb are compared to patients with injury of the lower limb as well as healthy controls.


Eligibility Criteria:
Inclusion Criteria:

- \>18 years, signed consent form, stable pain mediaction for 48 hours

Exclusion Criteria:

- \<18, unsigned consent form, dose change of the pain medication during the last 48 hours...
Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients

This is an observational study related to a medical device designed for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with gastrointestinal cancer. The primary objective is to collect data through interviews with patients experiencing OIPN symptoms to co-design the medical device prototype, incorporating the patient's perspective. Additionally, the study aims to identify clinical and usability patterns that will help optimize the design of a future clinical investigation assessing the safety and efficacy of the final device.

Main Hypothesis:

The clinical data collected from patient interviews, along with their active participation in the co-design of the localized cooling medical device, likely in the form of gloves, will enable the design of both the functional prototype and the future clinical research on safety and efficacy. This approach will increase the likelihood of patient acceptance of the medical device treatment and help identify different patient profiles that could benefit the most from it.

Secondary Hypotheses:

1. Patients will be able to easily adhere to the use of the device during chemotherapy.
2. The final glove design, in terms of materials and structure, will be suitable for commercial manufacturing and will have a viable demand among patients and healthcare providers.
3. There is no difference in treatment adherence between men and women or among people of different ages.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient patient with gastrointestinal cancer treated with oxaliplatin.
* Having completed at least three cycles of chemotherapy.
* Presenting acute or chronic symptoms of chemotherapy-induced peripheral neuropathy.
* The study will include individuals over 18 years old. Gender identify will be collected confidentially and inclusively, offering options for non-binary individuals and those who prefer not to identify with binary categories.

Exclusion Criteria:

* Patient with osteoarthritis or arthritis in the hands.
* Diagnosis of any autoimmune disease affecting connective tissue, such as: rheumatoid arthritis, Raynaud's syndrome, lupus, scleroderma, dermatomyositis, vasculitis, or cryoglobulinemia.
Composite Repair Using Silane Coupling Agent

Evaluation the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS) criteria over one year.

some manufacturers have produced silane-containing adhesives in their new products, which might eliminate the need to apply separate silane. However, this silane coupling agent can be hydrolyzed by the acidic monomer in the adhesive making it useless. Acid resistance silane containing adhesive is the update version of the silane containing adhesive which provides a long lasting effective bond between the old and new resin composite restorations

Eligibility Criteria:
Inclusion Criteria:

* Participants Inclusion:

Patients aging (18-45). Patients with a high level of oral hygiene. Patients with good likelihood of recall availability. - Teeth Inclusion: The restorations were first placed 12 to 24 months ago. Teeth with healthy remaining tooth structure. Posterior restorations with approximately 3mm in size occlusal marginal defect. Asymptomatic teeth before repair.

Exclusion Criteria:

* Participants Exclusion:

Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.

-Teeth Exclusion: The restorations with large defects The restorations in the third molars Last experience with allergic reactions against any components of the used materials.

Patients receiving orthodontic treatment
MITAORTA - Role of Mitochondrial Dynamic in Aneurysm and Dissection of Ascending Thoracic Aorta

The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group

In an aortic aneurysm process, the alteration of the extracellular matrix (ECM) as well as the apoptosis of the smooth muscle cells are due to inflammatory phenomena and oxydative stress, involving mitochondria which has a key place within cells.

Mitochondrial fusion and fission constitute mitochondrial dynamic and are involved in the mechanisms described above.

The alteration of mitochondrial dynamics has been demonstrated in many pathologies, in particular neurological, cancer and cardiovascular disease and generally occurs in favor of fission.

In a mouse model (FASEB J, 2021, Robert P ), the role of mitochondrial fusion has been demostrated as a protective factor against hypertension in resistance arteries and a deletion of OPA1 (optic Atrophy 1) fusion protein may lead to aneurysm until aortic dissection. The results of this experimental study suggest a role of the alteration of mitochondrial dynamic in the development of aneurysm and aortic dissection.

Eligibility Criteria:
Inclusion Criteria:

* Aneurysm aortic group: patients treated for an aneurysm of the ascending thoracic aorta with surgical indication according to the ESC guidelines (2014).
* Aortic dissection group: patients treated for type A acute aortic dissection or intramural hematoma of the ascending thoracic aorta in emergency.
* Control group: patients operated for aortic valve replacement (little aortic sample before closing aortotomy) or coronary artery bypass grafting which the use of a saphenous graft and the performance of a proximal anastomosis on the ascending aorta is planned

Exclusion Criteria:

* Patients under 18 years old
* Other acute aortic syndromes (penetrating ulcers, iatrogenic or traumatic dissections)
* Patients treated for aortic valve replacement in the context of infective endocarditis
* Patients treated for emergency aortic valve replacement or coronary bypass surgery\*\*
* Pregnant, parturient and breastfeeding women
* Patients protected by an administrative or judicial measure (curatorship, guardianship)
* Patients receiving psychiatric care under duress
* Adults subject to a legal protection measure.
* Patients whose the samples planned for the study could not be taken;
* Patients in the control group whose tissue sampling will not be performed.
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).


Eligibility Criteria:
Inclusion Criteria:

* Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion Criteria:

* Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
* Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
* Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
Dinoprostone vs Misoprostol Before LNG-IUD Insertion

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain


Eligibility Criteria:
Inclusion Criteria:

* multiparous women requesting IUD insetion

Exclusion Criteria:

* active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603.

Following a discussion with the FDA, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up.

During this safety follow-up period, participants underwent either intravenous (IV) or SC treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the participant and the investigator.

IGSC, 10% is the same product as IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% (IGIV, 10%) quoted in study 160603.

IGSC, 10% is abbreviated to IGI, 10% \[IMMUNE GLOBULIN INFUSION (HUMAN), 10%\]

In the US the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and SC replacement therapy of antibody deficiency in patients with PID.

In the EU this product is licensed (trade name KIOVIG)

IGSC, 10% with rHuPH20 established name is Innume Glubulin Infusion 10% (Human) with Recombinant Human Hyualuronidase.

US trade name is HYQVIA EU trade name is HyQvia

Eligibility Criteria:
Inclusion Criteria:

* Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160603. Participants who have discontinued rHuPH20 and reverted to intravenous or subcutaneous treatment due to an anti-rHuPH20 antibody also may enroll for long-term safety monitoring.
* Participant/caretaker has reviewed, signed and dated informed consent
* Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in Study 160902
* Participant is scheduled to participate in another non-Baxter clinical study involving an investigational product or investigational device during the course of this study
* If female of childbearing potential, participant is pregnant or has a negative pregnancy test and does not agree to employ adequate birth control measures for the duration of the study