cyrilzakka/clinical-trials huggingface dataset:
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.

Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4+ cell count \>= 200/microliter or \> 14% CD4+ cells in peripheral blood.
* Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

* Fertile females.
* Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer.

Patients with any of the following prior conditions are excluded:

HIV related pre-existing peripheral neuropathy.

Prior Medication:

Excluded:

Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide.

Required:

10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.
Quality of Life and Sexual Function in Vaginal Aplasia Patients After Davydov Procedure

Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. In Vietnam, since 2014, Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam. However, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. The objective of this study is to assess the quality of life, the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure.

This study will be conducted at Tu Du Hospital, Ho Chi Minh City, Vietnam. Female patients diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome were performed the Davydov procedure to create neovagina at the Anaesthesia and Intensive care department, Tu Du hospital. Based on the Department of Anaesthesia and Intensive care data, a list of potentially eligible patients who underwent Davydov surgery at least six months was made. Because of the impact of the Covid 19 pandemic, the patients could not come to the hospital, so the research team decided to interview the participants online. According to this list, patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the Davydov procedure. The informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment. On appointment day, the investigator will make group telecommunication by an application on cell phone or computer. Efficacy of Davydov procedure according to the functional aspect: the psychological doctors assess the impact of patient's neovagina on life and sexual function through questionnaires involving World Health Organization Quality of life Scale (WHOQoL-BREF), Female Sexual Function Index (FSFI) and self-composed qualitative questionnaire. The interview with a patient will be held individually and conducted by the psychological doctor. The participants will be requested to record the conversation. Because MRKH syndrome is a rare condition, the investigators take all patients who are suitable to inclusion criteria and accept participating in our research.

Eligibility Criteria:
Inclusion Criteria:

* Aged equal or more than 18.
* Diagnosed vaginal agenesis and underwent Davydov procedure to create neovagina at least 6 months.
* Able to listen, understand and answer questions.

Exclusion Criteria:

* Disagreed to participate the research.
* Having any conditions that make patient unable to listen, understand and answer questions.
* Having psychological disturbance.
What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?

Our objective is to examine the impact of residing in urban or rural areas on the utilization of healthcare services, self-efficacy, and quality of life among individuals with hemiplegia in Turkey.

In this upcoming cross-sectional study, we will assess patients with hemiplegia who are scheduled to visit the physical medicine and rehabilitation outpatient clinic. Each participant will undergo a personal interview to fulfill the Stroke Self-Efficacy Questionnaire (SSEQ) and Stroke Specific Quality of Life Scale (SS-QOL). We will utilize the hospital database to determine the frequency of emergency department visits, physical medicine and rehabilitation outpatient clinic appointments, and general practitioner clinic visits specifically for hemiplegia in the previous year.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Stroke.
* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Inability to read and comprehend.
* Severe cognitive impairments or communication difficulties.
* Severe visual or motor impairments
Prehabilitation in Gynaecological Cancer Patients

Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients.

PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.

The objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients undergoing surgical treatment for gynaecological cancer.

Two groups of patients scheduled for postponed surgical treatment will be eligible for the trial: i) advanced ovarian cancer patients referred for neoadjuvant chemotherapy and interval debulking surgery; ii) stage I-II endometrial cancer patients classifying as frail (according to the validated modified Frailty Index), who will be treated by hormonal therapy for three months, followed by surgical treatment.

Eligibility Criteria:
Inclusion criteria

Two groups of patients will be eligible for the trial:

i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery

ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.

Exclusion criteria

1. Second malignant tumour (under the treatment)
2. Patient is not suitable for any surgery delay
3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk
Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting

The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.


Eligibility Criteria:
Inclusion Criteria:

1. are 18-years old and older;
2. is able to sign and date the informed consent form; AND
3. have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.

Exclusion Criteria:

1. Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient.
2. Pregnant or lactating women
3. Who were previously enrolled in this study;
4. Who have contraindication for the radiopharmaceutical
5. Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
Effects of Home Based Step Aerobic Exercises

The aim of this study is to determine the effects of commercially produced new generation smart step board and step-aerobic exercises for 6 weeks on the functional capacity and physical performance of young sedentary individuals.

The aim of this study is to determine the effects of commercially produced new generation smart step board and step-aerobic exercises for 6 weeks on the functional capacity and physical performance of young sedentary individuals. The primary outcomes to be evaluated are the functional improvements in individuals' balance, functional capacity, muscle strength, and resting heart rate after 6 weeks of step-aerobic exercises. Secondary results are the evaluation of the effects of individuals on jumping performance and exercise motivation. It is thought that the results obtained in the study will reveal new information for studies investigating home-based exercise and rehabilitation practices and may provide evidence for larger studies involving a diagnosis of a disease in the future.

Eligibility Criteria:
Inclusion Criteria:

* Not participating in an exercise program that is followed regularly for at least 6 months
* Able to use a wearable device and willing to regularly step aerobic exercise
* In possession of a smart phone, tablet or computer
* BMI 25 to 40 kg/m2

Exclusion Criteria:

* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer, and cardiovascular, orthopedic, neurological psychological other diseases
* Not continuing the exercise program for more than three
* Loss of balance due to loss of consciousness or dizziness in the last 6 months
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1

This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the breast
* 18 years or older
* Karnofsky performance status greater than or equal to 70%
* Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting
* All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less than or equal to 1
* Lab results, within 10 days of MKC-1 administration:

  * Hemoglobin less than or equal to 9 g/dL
  * Absolute neutrophil count greater than or equal to 1.5 x 10\^9/L
  * Platelet count greater than or equal to 75 x 10\^9/L
  * Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
  * AST less than or equal to 2.5 x ULN
  * Serum albumin greater than or equal to LLN (lower limit of normal)
  * Total bilirubin less than or equal to ULN
  * Alkaline phosphatase less than or equal to 2.5 x ULN
* Signed informed consent

Exclusion Criteria:

* Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy
* Administration of cancer specific therapy within the following periods prior to study drug initiation:

  * chemotherapy less than 3 weeks prior
  * hormonal therapy less than one week prior
  * radiation therapy less than 2 weeks prior
* Be pregnant or lactating; not employing effective birth control
* Known central nervous system (CNS) metastases unless treated, clinically stable and not requiring steroids
* Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy
* Administration of any investigational agent (therapeutic or diagnostic) within 4 weeks prior to receipt of study medication
* Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL)
* Serious cardiac condition
* Any medical conditions that, in the investigator's opinion would impose excessive risk to the patient
* Patients with previous malignancies unless free of recurrence for at least 5 years except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix
* Treatment with antiretroviral therapy metabolized through CYP3A4
Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively.

The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;

For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and giving oral informed consent regarding TEC-ADHERE study and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations;
* Diagnosis of RR-MS;
* Initiating oral DMF according to Summary of Product Characteristics (SmPC) at the inclusion visit;
* Expanded Disability Status Score (EDSS) under 6.

Key Exclusion Criteria:

* Participants with progressive form of Multiple Sclerosis (MS);
* With memory or psychiatric disorders preventing them to complete questionnaires in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19

The SarcoV study aims at assessing the association between sarcopenia and the indication of mechanical ventilation in older hospitalized patients due to COVID-19 infection

Sarcopenia is disease associated with poor clinical outcomes. In critical ill chirurgical patients, sarcopenia is associated with difficult to wean of mechanical ventilation. The association between sarcopenia and mechanical ventilation is poorly studied in medical patients. COVID-19 pandemic has led a lot of medical patient to be admitted in intensive care units due to acute respiratory failure with need of mechanical ventilation support.

The primary objective is to determine if sarcopenia in critically-ill older patients with COVID-19 is associated with the indication of mechanical ventilation. Secondarily, the study aims at determining if sarcopenia is associated with difficult to wean and mortality in critically-ill older patients with COVID-19.

Eligibility Criteria:
Inclusion criteria

* Consecutive patients aged 60 and older
* Admission in an acute care unit in Brugmann university hospital due to a COVID-19 possible or confirmed infection. A infection was considered confirmed in presence of a positive molecular test by Polymerase-chain reaction (PCR), following the Belgian Public Health Department recommendations (Sciensano recommendations).

Exclusion criteria

* Patients unable to perform a grip-strength measurement due to any rheumatological or neurological condition.
Severity Grading of Unexpected Events in Pediatric Surgery

Data on all patients who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively. The department represents the only tertiary academic institution of the german province of Lower-Saxony (8 million inhabitants). The clinical spectrum of the department includes surgery of the neonate, gastrointestinal, hepatobiliary, thoracic and oncological surgery and pediatric urology.


Eligibility Criteria:
Inclusion Criteria:

* All patients with unexpected events during the in-hospital stay, in outpatient clinics and in the pediatric emergency department
* Informed consent was obtained from the legal guardian´s at admission

Exclusion Criteria:

* If no informed consent was obtained from the legal guardian´s at admission
Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

Organ protection, volatile anesthetics, postconditioning.

Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.


Eligibility Criteria:
Inclusion criteria:

* CABG and/or heart valve surgery with CPB
* Ejection fraction (EF) = 30%
* Canadian Cardiovascular Society (CCS) classification = 3
* Ages 18 to 90 years old

Exclusion criteria:

* Pulmonary disease: forced expiratory volume in one second (FEV1) \< 80%; FEV1/forced vital capacity (FVC) \< 70%
* Renal disease and/ or creatinine-clearance \< 60 ml/min
* Previous cardiac surgery
* Emergency procedures
* Postoperative intra aortic balloon pump (IABP) requirement
* Myocardial infarction \< 7d
* Steroid treatment
* Insulin-dependent diabetes
* Pregnancy
Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients

Cardiac arrest is one of the critical illnesses that is directly life-threatening, and patients who survive cardiac arrest develop severe neurological deficits or even die. The effectiveness of drugs to improve neurological function in resuscitated brain-injured patients has been a focus of research in the field of resuscitation. Butanephthalein has an ameliorating effect on the damage of central nervous function in patients with acute ischemic stroke, and can promote the improvement of patients' neurological deficits. On this basis, the present study was designed as a multicenter, prospective randomized controlled experiment, with internationally accepted methods for assessing near-term and long-term neurological function, to determine the effectiveness of butalbital in improving neurological function after cardiac arrest, with the aim of searching for new methods and ideas to improve neurological function and prognosis after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old.
2. Glasgow Coma Scale (GCS) scores ≤8 upon admission.
3. Return of Spontaneous Circulation (ROSC) ≥30min.
4. Signed the informed consent form.

Exclusion Criteria:

1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.
2. Cardiac arrest due to end-stage conditions such as advanced cancer.
3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \<90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).
4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.
5. Pre-existing CPC scores of 3-5 prior to cardiac arrest.
6. Prior use of NBP or any medication containing NBP before cardiac arrest.
7. Presence of severe hepatic or renal dysfunction before cardiac arrest (defined as ≥3× upper limit of normal alanine transaminase or ≥2× upper limit of normal creatinine).
8. Bradycardia or sick sinus syndrome occurs after ROSC.
9. History of prior drug or food allergies, or known allergies to the medication components used in this study.
10. Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).
11. Presence of severe bleeding tendency upon admission.
12. Body temperature \<30℃ upon admission.
13. Pregnant or lactating women, or reproductive-age females with elevated serum human Chorionic Gonadotropin (hCG) levels.
14. Other conditions deemed unsuitable for this trial by the principal investigator.