cyrilzakka/clinical-trials huggingface dataset:
Doxil and Gemcitabine in Recurrent Ovarian Cancer

Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.

This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.

Eligibility Criteria:
Inclusion Criteria:

* recurrent platinum resistant ovarian cancer
* measurable disease

Exclusion Criteria:

* prior treatment with Doxil or Gemzar
* life expectancy \<3months
* cardiac ejection fraction \<50%
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

A study to help manage chronic pain in cancer survivors through Acceptance and Commitment Therapy (ACT) after undergoing active cancer treatment, such as surgery, chemotherapy, and/or radiation.

This study attempts to apply effective pain management interventions from other chronic pain populations to those of cancer related populations. It will assess the ability of ACT to alleviate chronic cancer related pain and evaluate ease of implementation of treatment. Patients will be allocated to either the intervention group (ACT) or the control group, getting them the usual course of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a male or female aged 18-100
4. Have pathology confirmed diagnosis of a solid tumor cancer
5. Be three or more months out from active cancer treatment (surgery, chemotherapy, and/or radiation)
6. Endorses experiencing pain for three or more months prior to eligibility screening
7. Indicates moderate to severe difficulties with pain interference as related to their cancer experience, with a score of 4 or higher on the pain interference item from the Chronic Pain Grading Questionnaire
8. Shows no evidence of cancer disease (NED) or with stable, chronic disease under "watchful waiting"
9. Fluent in English
10. Psychiatric stability as assessed by chart review and study personnel (e.g., not exhibiting symptoms consistent with diagnoses of serious mental illness such as active psychosis or mania)

Exclusion Criteria:

1. Having pain that can be solely attributed to a diagnosis outside of their cancer experience
2. Presenting with barriers to group participation (e.g., social anxiety) or when group-based provision of care would impede participant's treatment or that of other group members
3. Patients with a diagnosis of malignant neoplasm of the brain (ICD-10 C71) or malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system (ICD-10 C72).
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome

The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
* Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
* Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
* Ability to provide written, informed consent

Exclusion Criteria:

* Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
* Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
* Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
* Any abnormalities or conditions deemed by the investigator as clinically significant
Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg) plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient from the societal perspective over one year.

Prospective double blinded randomized controlled study Will be carried out at Ain-Shams university hospital Method: - After approval of the research ethics committee of Ain shams University and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College of Chest Physicians (ACP) \*will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups.

Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be treated according SSCG plus simvastatin.

Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.

Secondary Outcome Measures:

* Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation
* Total ICU length of stay.(LOS)
* Number of patients alive 3, 6, and 12 months
* Incremental cost effectiveness ratio

Eligibility Criteria:
Inclusion criteria:-

1. Age \>18 and less than 70
2. Sepsis for less than 24 hours from ICU admission

Exclusion criteria:-

1. Elderly (defined as older than 70).
2. Pediatrics (defined as younger than 18).
3. Pregnancy and nursing.
4. Unable to receive enteral medications.
5. History of hypersensitivity to the trial drug.
6. Are receiving drugs known to interact with simvastatin.
7. Acute liver failure and chronic liver disease (Child C).
8. High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(\>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal.
9. Patients with dyslipidemia or Prior statin user.
10. Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism
11. Have a history of known or suspected porphyria
12. Are unlikely to survive more than 24 hours
Complex Exercise Program for Stroke Patients

The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.


Eligibility Criteria:
Inclusion Criteria:

* Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital
* Independent ambulator (FAC over 4)
* Independent daily activities (Modified Rankin Scale less than 2)
* No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)
* Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3

Exclusion Criteria:

* MMSE less than 18
* BBS less than 41
* Severe aphagia who cannot communicate
* Severe cardiovascular conditions inhibiting exercise programs
* Musculoskeletal problems inhibiting exercise programs
* Other medical conditions considered by physiatrists
Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women

The frequency of violence against women, or intimate partner violence (IPV) is more and more underlined and recognized as a cofactor favoring certain somatic and psychic pathologies. However, its incidence in patients with venous thromboembolism (VTE) is unknown and its status as a risk factor is still elusive and ambiguous.

Investigators therefore conducted a matched case-control study consisting of women taking combined oral contraceptives (COC) who were investigated and followed up between 2010 and 2020.

The cases are the patients investigated for their first venous thromboembolic event, The controls were women free of thrombosis who had regular gynecological checkups. Case-control pairs were matched on region of residence, age (+/- 2 years), duration of COC intake (+/- 4 months), COC type (2nd, 3rd or 4th generation).


Eligibility Criteria:
* Patients: first venous thromboembolic event associated with the intake of combined oral contraceptives
* Controls: regular follow-up of their combined oral contraception
* Patient-Control pairs matched on region of residence, age, duration of COC intake, type of COC.
A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer

This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug.

Exclusion Criteria:

* There were other malignant tumors within 3 years;
* Has multiple factors affecting oral medication;
* Unalleviated toxicity ≥ grade 1 of CTCAE v5.0 due to any previous therapy , excluding hair loss;
* Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study，or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
* Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
* Have a history of psychotropic drug abuse and can not quit or have mental disorders;
* Subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.;
* Tumor-related symptoms and treatment:

  1. Has known symptomatic central nervous system metastases and/or cancerous meningitis;
  2. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time;
  3. Has participated in other clinical trials within 4 weeks before first dose.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

Eligibility Criteria:
OAB subjects (n=10 Phase I and n=10 Phase II)

Inclusion Criteria:

* Female
* Age 18-75 years
* Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
* At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
* InterStim® treatment naïve or being revised with a new lead

Exclusion Criteria:

* Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
* Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
* Revision of only the IPG (without replacement of the tined lead)
* More than one InterStim® device being placed (undergoing bilateral stimulation)

Controls (n=10)

Inclusion:

* Female
* Age 18-75 years
* Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
* American Urological Association (AUA) symptom score of ≤4

Exclusion:

-History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY

PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.

The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward.
2. Adult age (≥18 year old in US and Europe; ≥20 years old in Japan; ≥21 years old in Singapore).
3. Patient is able and willing to give informed consent.

Exclusion Criteria:

1. Expected length of stay ≤ 24 hours.
2. Patient is receiving intrathecal opioids.
3. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
4. Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
5. Ventilated or intubated patients.
6. Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.
7. Patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support.
8. Patient is participating in another potentially confounding drug or device clinical study.
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy

The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.


Eligibility Criteria:
Inclusion Criteria:

1. CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.

   * Matutes score must be 4-5/5.
   * Initial cytopenia (due to CLL) are not exclusion criteria.
   * Lymph node biopsy is needed only if suspicion of Richter syndrome.
   * Mandatory pre-therapeutic check-up: FISH in search for deletion del17p and del11q, DAT test, haptoglobin levels, creatinine clearance.
2. Eligibility to a treatment with FCR: clearance \> 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.
3. Signed informed consent
4. Age\> or equal 18 years, ECOG PS 0-2.
5. Estimated overall survival\>6 months.
6. Conserved liver function (bilirubin\<2,5mg/dl, SGPT\<4ULN, SGOT\<4ULN) except infiltration due to the disease.
7. Contraception for younger patients.
8. Confident with the use of telephone, no disabling deafness.

Exclusion Criteria:

1. Richter syndrome or atypical CLL (Matutes score \<4), and/or del17p by FISH
2. Relapse of CLL
3. Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance\<30 ml/mn.
4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection
5. Previous history of hypersensibility to any product used in this protocol
6. Denial, or medical or psychological condition preventing completion of the signed informed consent.
7. Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study.
8. Pregnant/breastfeeding women.
9. CNS involvement by CLL.
10. Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).
Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Sufentanil combined with ropivacaine is commonly used for epidural labor anesthesia. However, this combination is associated with some adverse events including increased risk of neonatal depression. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and possesses opioid-sparing and analgesic effects when used in combination with local anesthetics. Recently published data suggest that dexmedetomidine-ropivacaine combination can effectively relieve labor pain.

We suppose that, when compared with traditional sufentanil-ropivacaine combination, the dexmedetomidine-ropivacaine combination used for epidural labor analgesia may reduce sufentanil-related adverse neonatal outcomes. The purpose of this pilot trial is to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination used for epidural labor analgesia on neonatal outcomes, and also to test the feasibility of a future large randomized trial.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-45 years;
2. Single term pregnancy with vertex presentation planning vaginal delivery;
3. Planning to receive epidural labor analgesia.

Exclusion Criteria:

1. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
2. Existence of bradycardia (heart rate \<60 bpm), hypotension (SBP \<90 mmHg) or severe hypertension (SBP ≥180mmHg), uncontrolled systemic comorbidities (i.e., diabetes or hepatic, renal or cardiac disease), American Society of Anesthesiologists (ASA) physical status ≥3.
3. History of psychiatric disease or epilepsia.
4. Allergy to study agents.
5. Other conditions that are considered unsuitable for study participation.
Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

This study is to evaluate the safety and efficacy of Virtual Reality Mindfulness in Patients With Psychosis.

This study is randomized, single-blind and parallel group trial to evaluate the safety and the efficacy of Virtual Reality Mindfulness in Patients With Psychosis once a week over 8 weeks treatment period. Both groups can experience the screen coming out of the head-mounted display for 30 minutes in a comfortable sitting position.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who are 15-59 years (inclusive) of age at time of consent.
* Patients with current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-fifth edition) diagnosis schizophrenia spectrum and other psychotic disorders including bipolar and related disorders or depressive disorder with psychotic symptoms.
* Patients who can agree to participate in the study in a stable state (Clinical Global Impression score of 5 or less) and cooperate appropriately with questionnaires and tests.
* Patients with a SOFAS score in the range of 41 to 80 points.
* Patients with a PANSS score of less than 85 points.

Exclusion Criteria:

* Patients who are currently in poor health due to serious physical illness
* Patients who are currently pregnant or lactating.
* Patients who are accompanying intellectual disability with an Intelligence Quotient (IQ) of 70 or lower
* Patients who have difficulty in agreeing to and participating in research due to severely impaired ability to verify reality
* Patients with a PANSS score of 85 or higher or a CGI of 6 or higher
* Patients with a SOFAS score of 40 or less or 81 or more
* Patients who are currently in hospitalized
Rapid Prehospital ACcess to ECPR in Prague

A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA

The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.

Eligibility Criteria:
Inclusion Criteria:

* Estimated age 18-70 years
* Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity)
* Witnessed cardiac arrest
* ECPR team available
* ECPR team alert within 20 minutes from the emergency call

Exclusion Criteria:

* Unwitnessed cardiac arrest
* Asystole
* ETCO2 less than 10 mmHg upon ECPR team arrival
* Known limitations of intensive care (Do Not Resuscitate - DNR status)
* Known severe neurological impairment prior to cardiac arrest (mRS 4-6)
* Suspected or known pregnancy
Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity

This trial main purpose is to develop and test an mHealth app aimed at improving self-management, self-care and adherence of people with obesity.

The study population are type I or II obese people, aged more than 18 years old, with or without comorbidities, who have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and access to a scale for regular weight monitoring.

Control group will follow standard care protocol and patients in the intervention group will also be provided with the app. Follow-up will be done for 16 weeks. Both groups will attend 3 face-to-face visits (baseline, 2 and 4 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* People with BMI 30-39.9 kg/m2.
* Have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and have sufficient capabilities to use it.
* Have access to a scale for regular weight monitoring.

Exclusion Criteria:

* Presence of serious major comorbidities: High blood pressure treated with \> 3 drugs, diabetes mellitus treated with insulin, dyslipidemia treated with PCSK9 inhibitors, sleep apnea-hypopnea syndrome treated with CPAP, ischemic heart disease or stroke.
* Use of pharmacological treatment with influence on weight started in the 6 months prior to study entry.
* History of weight loss intervention (diet, exercise) in the 6 months prior to study entry.
* History of eating disorder.
* History of bariatric surgery.
* Use of any other app or treatment to lose weight in the 6 months prior to study entry.
* Pregnancy, short-term gestational desire or lactation.
* Any other disease or condition that may interfere with compliance with the protocol or completion of the study.