cyrilzakka/clinical-trials huggingface dataset:
Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy

Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old planning their first external beam radiotherapy
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion Criteria:

* Have received external beam radiotherapy in the past
* External beam radiotherapy is initiated as inpatient.
* External beam radiotherapy consists of less than 3 fractions.
* Planned radiotherapy that does not employ an external beam
* Planned participation in a clinical study that prohibits participation in a second, concurrent treatment trial
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.

Investigators aim to measure the ankle talar cartilage and achilles tendon thicknesses ultrasonographically in paraplegic patients and compare them with the normal population.

Paraplegia is a clinical condition that expresses the loss of motor and sensory function in the lower extremities after spinal cord injury. A specialized and intensive rehabilitation program is needed in these patient groups who develop immobilization. In healthy individuals, there is a certain biomechanics of the lower extremity. In paraplegic patients, this biomechanics changes due to weakness in the lower extremities. These biomechanical changes can cause different loads and effects on the lower extremity joints, muscles, tendons, and articular cartilages of paraplegic patients. Among the rehabilitation goals of paraplegic patients, it is to stand up and walk the patient with or without support, with or without a device. During this rehabilitation, the position and function of the ankle is important. In this process, the talar condylar cartilage and achilles tendon forming the ankle joint can be exposed to different loads.

Ultrasonography is frequently used in physical therapy practice because it does not contain any radiation, has no side effects to the patient, facilitates dynamic and real-time evaluation of joint and muscle conditions and functions, and provides guidance during interventional procedure planning. In this study, investigators aim to ultrasonographically measure ankle talar cartilage and Achilles tendon thicknesses in paraplegic patients with long-term immobilization and compare them with the normal population.

Our study will be organized as a observational study. It is planned to include 20 paraplegia patients and 20 healthy volunteers in the study.

Demographic data of the patients and healthy volunteers will be recorded. Paraplegia patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, American Spinal Injury Association (ASIA) scale, Walking Index for Spinal Cord Injury Scale (WISCII-2).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are paraplegic after traumatic spinal cord injury (ASIA A-D)
* Healthy volunteers older than 18 years for control patients.

Exclusion Criteria:

* Patients who had a previous trauma-related operation on the ankle.
* Patients who had fixed contracture or severe spasticity on the ankle.
* Patients who had lower-limb length difference of more than 2 cm.
Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15

After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, \[...\], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
* Patient agreeing to use his data for research purposes

Exclusion Criteria:

* Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire
* Patient unable to express non-opposition to participation in the study
* Patient expressing opposition to participating in the study
First-degree Ankle Sprains

Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Grade I acute ankle sprain confirmed by a specialist physician in radiology,
* Age of participants ≥ 18 years,
* Individuals of both sexes

Exclusion Criteria:

* Recurrent ankle injury,
* Acute ankle sprains of Grade II and III,
* Presence of other physical and/or mental health issues.
Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy

The purpose of this study was to understand the epidemiological status of Fabry in patients with hypertrophic cardiomyopathy or left ventricular hypertrophy through multi-center early identification of high-risk patients in cardiology according to high-risk profiles, supplemented by DBS (dried blood disc) screening tools, and to explore the screening and diagnosis methods of patients with Fabry disease in cardiology, so as to promote the early identification, diagnosis and treatment of Fabry in cardiology.


Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for hypertrophic cardiomyopathy (HCM) in adults (age ≥ 18 years):Imaging of one or more left ventricular segments reveals a maximum end-diastolic ventricular wall thickness of ≥15 mm or end-diastolic ventricular septal thickness or posterior left ventricular wall thickness of ≥13 mm on either cardiac imaging at rest.

Exclusion Criteria:

* 1. Identification of hypertrophic cardiomyopathy caused by mutations in pathogenic genes; 2. Identify the cause of left ventricular hypertrophy (LVH); 3. Aortic valve or mitral valve lesions that can cause hemodynamic changes.
A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility


Eligibility Criteria:
Inclusion Criteria:

* Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra
* Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician
* Have adequate hematologic and end-organ functions
* Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible ("unfit") for cisplatin-based chemotherapy

Exclusion Criteria:

* Have received prior immune checkpoint therapy
* Are pregnant or breastfeeding
* Are included in any other trial
Influence of Stroke on the Composition of Intestinal Microbiota

The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* age: 18 and older
* ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity
* patient consent or consent by a legal representative
* NIHSS \> or =9 (stroke patients)
* NIHSS \< 1 (for TIA patients)

Exclusion Criteria:

* intracranial hemorrhage
* preexisting dysphagia
* signs of infection upon admission (clinical/paraclinical)
* existing antibiotic therapy upon admission or within the last 2 weeks before admission
* mechanical ventilation upon admission
* participation in an interventional therapy study
Individualized PEEP and Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery

In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.

This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.

Eligibility Criteria:
Inclusion Criteria:

* elective RALP surgery under genenal anesthesia
* ASA 1-2
* 19 years of age or older
* Consented to participate in the study

Exclusion Criteria:

* Do not consent to participate in the study
* ≥ BMI 40 kg/m2
* Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests
* Preoperative serious cardiovascular disease
* Required postoperative ventilator care at ICU care
Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels

The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.

The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.

Despite current consensus in the literature that Female Sexual Dysfunction can manifest at any age in a woman´s life, researchers as Sarrel documented that during menopause, up to 40% of women are experiencing a decrease in their sexual libido. The common assumption is that the menopause contributes to a drop of the sexual desire probably as a result of low production of hormones from ovaries, at the same time will reduce the estrogen and testosterone. This reduction starts to be reduced in the thirties and continues to reduce progressively at a constant rate reaching of about 50% of their initial highest levels by the time they reach menopause. Other hormones could be involved as Sex hormone-binding globulin (SHBG) or dehydroepiandrosterone (DHEA), both are related with testosterone levels.

Libicare® is a dietary supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged between 40 and 60 years old.
2. Healthy peri or postmenopausal women.
3. Body Mass Index (BMI) between 18,5-29,9.
4. Female with low sexual desire and low arousal with a score ≤26.55 on the questionnaire Female Sexual Function Index (FSFI) .
5. Patients who signed the Informed Consent Form.

Exclusion Criteria:

1. Female with uncontrolled thyroid function.
2. Female with severe genital pain (vaginism, stopping intercourse because of severe pain).
3. Female diagnosed with primary female orgasmic disorder.
4. No coital intercourse a month.
5. Lack of steady sexual partner.
6. Suffering from any serious medical condition (any disease which may force the participant to use drug during the study).
7. Suffering from major depression disorder or other psychiatric disorders.
8. Women on anticoagulant treatment.
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Consent form
* men and women\> 18 years \<75 years
* invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

Exclusion Criteria:

* Pregnancy or lactation
* Change in medication during the last 2 months
* Patients with signs of right heart decompensation
* severe walking disturbance
* uncertain diagnoses
* No previous invasively confirmation of PH
* acute diseases, infections, fever
* Serious lung disease with FEV1 \<50% or TLC \<70% of target
* Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function
Young-onset Colorectal Cancer Screening Based on Artificial Intelligence

In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data.

Diagnosis of young-onset colorectal cancer (YOCRC) has become more common in recent decades. Screening CRC among younger adults still remains a challenge. In this study, We plan to retrospectively extracte the relevant clinical data of young individuals who underwent colonoscopy from 2013 to 2022 using Electronic Medical Record (EMR). Multiple supervised machine learning techniques will be applied to distinguish YOCRC and non-YOCRC individuals, the above classifiers will be trained and internally validated in the training dataset and internal validation dataset admitted between 2013 and 2021, respectively. We will also assess the temporal external validity of the classifiers based on the admissions from 2022.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with CRC (YOCRC group)
* Age at 18-49 when diagnosis (YOCRC group)
* Never received any CRC-related treatment (YOCRC group)
* No CRC confirmed by colonoscopy or pathology (non-YOCRC group)
* Age at 18-49 (non-YOCRC group)

Exclusion Criteria:

* Hospital stay less than 24 hours or with incomplete Complete Blood Count
* Patients with inflammatory bowel disease or hereditary CRC syndromes
* History of other types of primary malignant tumor and other reasons that made them unsuitable for enrollment
APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Eligibility Criteria:
Inclusion Criteria:

* Stage 0, I or II breast cancer.
* Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
* Ductal carcinoma in situ (DCIS) alone.
* No lymph invasion (L0) and no hemangiosis (V0).
* Lesions of \> 3 cm diameter, histopathologically confirmed.
* pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional.
* M0.
* Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
* For DCIS only: lesions must be classified as low or intermediate risk group (Van Nuys Prognostic Index \<8).
* Unifocal and unicentric DCIS or breast cancer.
* Age \>= 40 years.
* Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
* Signed study-specific consent form prior to randomization.

Exclusion Criteria:

* Stage III or IV breast cancer.
* Surgical margins that cannot be microscopically assessed.
* Extensive intraductal component (EIC).
* Paget's disease or pathological skin involvement.
* Synchronous or previous breast cancer.
* Prior malignancy (\< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma FIGO 0 and I if patient is continuously disease-free.
* Pregnant or lactating women.
* Collagen vascular disease.
* The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar.
* Psychiatric disorders.
* Patient with breast deemed technically unsatisfactory for brachytherapy.
A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week

This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, Japanese subjects, aged 20 - 64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
* Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day.
* Body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive).
* HbA1c less than or equal to 9.0%.

Exclusion Criteria:

* History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
* Known or suspected hypersensitivity to trial products or related products