cyrilzakka/clinical-trials huggingface dataset:
Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities

This work aims to:

1. Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on

   1. Specific neurologic deficit.
   2. Depressive symptoms.
   3. Comorbid factors.
   4. Fatigue symptoms.
2. To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
3. To search for possible gender difference.

The present study is a cross sectional study on 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals, Egypt.

All patients were subjected to the following:

1. Clinical Evaluation:

   1. Thorough neurological examination.
   2. Cognitive functions by Minimental State Examination (MMSE).

   e. Expanded Disability Severity Scale (EDSS).
2. Neurophysiological Evaluation:

   a. Visual Evoked Potential (VEP).
3. Imaging Evaluation:

   a. Conventional MRI.
4. Cerebrospinal Fluid (CSF):
5. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
6. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
7. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).

Eligibility Criteria:
Inclusion Criteria:

* 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals

Exclusion Criteria:

The exclusion criteria:

* Active relapse or relapse during 30 day prior to survey due to significant changes in all life activities during this period including sexuality.
* EDSS score equal or higher than 6.5.
* Current pregnancy in female patients.
* Form of the disease other than RRMS.
* Patients with any sort of cognitive impairment preventing them from understanding Questionnaire.
* Poorly controlled concomitant diseases were excluded.
* Patients with past history of any sexual problems prior to the first MS attack.
* UN married Patients.
Correlation Between Physical Fitness Status and Quality of Postoperative Recovery in Gynaecological ERAS Patients

Investigate the current status of perioperative physical fitness.To compare the degree of agreement between the 6-minute walk test and the EQ5D5L-VAS score in assessing recovery after gynecological ERAS, and to provide a reference for a more scientific and comprehensive assessment of patients' physical recovery after gynecological ERAS.

1. Investigate the current status of perioperative physical fitness and postoperative recovery quality of gynaecological ERAS patients
2. Explore the correlation between the physical fitness status of gynaecological ERAS patients and the quality of postoperative recovery.
3. Based on the correlation between patients' physical fitness status and the quality of postoperative recovery, to further determine the optimal threshold of the 6MWT distance

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years old;
* diagnosed with benign gynecological diseases and undergoing laparoscopic surgery;
* acceptance of ERAS modality;
* normal cognitive communication ability and proficiency in the use of smartphones;
* without motor disabilities.

Exclusion Criteria:

* unstable angina and myocardial infarction within 1 month;
* heart rate \>120 beats/minute at rest, systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg;
* diagnosis of anxiety and depression;
* pregnancy.
Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma

The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent form.
* Have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma and have high risk cytogenetics by IMW (del17p, or t(4;14) or t(14;16) or history of EMD, and must not have evidence of progressive disease by IMWG criteria(Appendix B) following CAR-T cell therapy.
* Have received \>2 prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor and a CD38 monoclonal antibody.
* Able to adhere to the study visit schedule and other protocol requirements.
* Patients must have available clonoseq ID prior to enrollment to track MRD status.
* Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
* Serum bilirubin levels ≤1.5 times the upper limit of the normal range for the laboratory (ULN), unless related to Gilbert syndrome.
* Serum AST or serum ALT levels ≤2 x ULN.
* Must have adequate bone marrow function.

Exclusion Criteria:

* Ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment.
* Ongoing CRS or ICANS of any grade.
* Active plasma cell leukemia.
* Patients with CNS involvement, including meningeal involvement.
* Patients with history of Guillain-Barre syndrome.
* Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma, which in the opinion of the treating physician pose an unacceptable risk to the patient.
* Pregnant or lactating females.
* Concurrent use of other anti-cancer agents or treatments.
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Note: patients with hepatitis C previously treated with curative intent are considered eligible.
* Patients with renal failure requiring dialysis.
Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial

During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation


Eligibility Criteria:
Inclusion Criteria:

* All women initiating IVF treatment

Exclusion Criteria:

* Women that have entered the study before
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD

This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden and lung function will be explored.

This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group, multicenter study with two fixed-dose levels of CSJ117 (4 mg, 8 mg) administered once-daily via oral inhalation over 12 weeks in participants with COPD, prone for exacerbations and symptomatic at baseline despite background maintenance triple therapy (inhaled corticosteroids/long acting beta-2 agonist/long acting muscarinic antagonist (ICS/LABA/LAMA) combination, standard of care in this population) for at least three months prior to screening.

The study will include:

* Screening period of up to 2 weeks to assess eligibility.
* Run-in period of 4 weeks where participants will be placed on fixed-dose triple background therapy (ICS/LABA/LAMA) that will be used until the patient's last study treatment.
* Treatment period of 12 weeks. Participants will be stratified by eosinophil levels and then randomized 1:1:1 to either 4 mg CSJ117, 8 mg CSJ117, or placebo.
* Follow-up period of 55 days following the last dose of study drug. The primary objective of the study is to assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
* Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit

Exclusion Criteria:

* Patients with a past or current medical history of asthma
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
* Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations
* Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
* Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply
Dysphagia on the Intensive Care Unit

Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care.


Eligibility Criteria:
Inclusion criteria:

* All senior ICU physicians in charge for adult critically ill ICU patients. Respective ICUs must be accredited by the "Schweizerische Gesellschaft für Intensivmedizin".
* ICUs located in Switzerland.
* Senior ICU physicians willing to voluntarily fill in the provided questionnaire.
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.

Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.

Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).


Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria :

* Histologically or cytologically-proven metastatic cancer of the colon or rectum.
* Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
* Male or female aged \>18 years.
* WHO Performance Status (PS) : 0 or 1.
* Measurable disease.
* No prior chemotherapeutic regimen for metastatic disease.
* Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
* Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
* Signed written informed consent prior to study entry.

Exclusion Criteria:

Main exclusion criteria :

* Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
* Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
* Peripheral neuropathy \>Grade 1.
* Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
* Concurrent active cancer originating from a primary site other than colon or rectum.
* Presence of any symptom suggesting brain metastasis.
A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure

Researchers want to learn more about the treatments doctors choose to treat heart failure.

Heart failure means the heart isn't pumping as well as it should be. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.

There are different types of treatments available for people who have heart failure, and these work in different ways. In this study, the researchers will collect information about Colombian patients who have heart failure.

The main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in Columbia. To do this, the researchers will review information from the patients' medical records and from a drug-dispensing database.

The study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020.

There will be no required visits, treatments, or procedures in this study. The researchers will collect information about the treatments the patients have been prescribed by their own doctors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (older than 18 years) with a diagnosis of HF according to ICD-10 with a dispensing of some medicine and it is registered in the database of Audifarma S.A. during the observation period will be included

Exclusion Criteria:

* Patients with Acute HF without prior diagnosis of HF
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients
* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
* Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion Criteria:

* Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease.
* Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
* Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points
Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy

The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:

Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?

Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.

Participants will:

Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
* The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc.
* There was no contraindication of puncture and cryobiopsy.
* Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.

Exclusion Criteria:

* The lesion is a mediastinal cyst or abscess.
* The patient is allergic to lidocaine and midazolam.
* The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer.
* Unstable angina pectoris, congestive heart failure, severe bronchial asthma
* The patient did not agree to participate in this study
* Participation in other studies within three months without withdrawal or termination will affect the observation of this study
* The researcher believes that there is any person who is not suitable for the selection
Potentiating Rural Investment in Children's Eyecare (PRICE)

The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable.

Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese children, accounting for 90% or more of poor vision, and Chinese children have among the highest rates of myopia in the world. Despite the fact that the problem of URE is safely and inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses sufficient to provide good vision in rural China.

PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and Guangdong (one of the richest) to optimize the model of "free glasses for all with an optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be varied between groups in order to find the optimal balance between high rates of purchase of upgrade glasses on the one hand and good acceptance and wear of free spectacles among those selecting them on the other.

Eligibility Criteria:
Inclusion Criteria:

1. Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.
2. A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.
3. All children in the selected classes.

Exclusion Criteria:

1. Those schools that the total number of students are more than 2000.
2. Those schools that the total number of students of 3, 4, 5 grades are less than 80.
3. Children suffering from eye diseases such as cataract, congenital ptosis, strabismus, congenital glaucoma will not be included in the study and will be recommended referral.
Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke

Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. However, there are no studies on the efficacy of the method in the recovery of the upper limb and the improvement of autonomy after stroke.

Methods: Randomized double-blind clinical trial with patients with stroke in semi-acute period, randomized into experimental group (EG) (conventional rehabilitation and Pilates) or control group (CG) (conventional rehabilitation).

After randomization and initial evaluation, the intervention will begin (2 sessions per week, 3 months). After completion, there will be post-intervention assessment, and another one at 1 month.

Intervention: The CG will receive 30 minutes of physical therapy and 30 minutes of occupational therapy. The SG will receive 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates.

Assessment instruments: Mean Functional Independence; Functional Range Test; Timed 'Up and Go'; Nine Hole Peg Test; Box and Block Test; Arm, Shoulder and Hand Disabilities Questionnaire; Client Satisfaction Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. present a diagnosis of ischemic or hemorrhagic stroke with a minimum evolution of 3 months;
2. be over 18 years of age;
3. regularly attend rehabilitation treatment at the Physiocare Madrid center;
4. present moderate functional problems (score greater than 65 on the Barthel Index);
5. not present moderate cognitive impairment (Mini Mental State Examination less than 18 points);
6. not present nasogastric tubes;
7. accept to participate voluntarily in the study and sign the informed consent form;
8. be able to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. time of evolution of less than 3 months;
2. other conditions of the central nervous system (tumors, anoxia, cranioencephalic trauma, etc.);
3. cardiorespiratory or neurodegenerative disorders, severe brain damage or a score of 6 or higher on the Reisberg Deterioration Scale (GDS);
4. a severely impaired level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
5. receiving other complementary rehabilitative therapy;
6. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
7. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
8. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS).