cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO

ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. However, some recent retrospective studies and a small number of single-center, small-scale prospective studies have shown that early activity of ECMO patients is feasible, and early active activity is associated with recovery of independent function and reduction of delirium incidence.


Eligibility Criteria:
Inclusion Criteria:

* ECMO time ≥1 day
* Aged older than16 years old and less than 70 years old

Exclusion Criteria:

* coma deep
* sedation muscle relaxation (RAAS-3-5)
* Active bleeding deep vein thrombosis
* High dose of vasoactive drugs
* unstable vital signs
* Acute stage of myocardial infarction (within 2d)
* Malignant arrhythmia
* pregnancy
Multi-Parametric Assessment of Breast Lymphedema

Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.

The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.

Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life.

At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.

The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.

Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 y/o
* Diagnosis of lymphedema involving the breast
* Diagnosis of in-situ or invasive breast cancer
* Female patients following breast conserving therapy and radiotherapy
* Spoken and written fluency in English; and
* Able to provide informed consent

Exclusion Criteria:

* Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis
* Prior breast surgery on the contra lateral breast
* Presence of active cellulitis within the breast, trunk or arm and
* Presence of active cancer
Clinical Trial to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic

The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).

It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* Documented HIV-1 infection.
* Be in treatment with these antiretrovirals (INI, IP, ITINAN) during 12 months.
* HIV-1 Viral titer \<50 copies/mL during 6 months.
* CD4\> 500 cells/mm3.

Exclusion Criteria:

* Treatment with antibiotics.
* Severe diseases actives.
* Defining diseases of AIDS in the previous year.
* Gut surgery except appendectomy or cholecystectomy.
* Pregnancy.
* Any diet deviation (vegans).
* Other probiotic treatment.
A Mobile Text Messaging Intervention for Indoor Tanning Addiction

The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of indoor tanning delivered via mobile text messaging among young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction.

This is a two arm randomized controlled trial to test the effects of messages communicating the risks of indoor tanning delivered via mobile text messaging as a strategy for promoting cessation among young adult women who meet screening criteria for indoor tanning addiction. Eligible participants are young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction and have access to the internet and a personal mobile phone to complete study procedures. Participants will complete baseline measures and then be randomized to the study arms. The text messaging intervention exposure in the intervention arm will last for four weeks. The control arm will be given basic indoor tanning education information and will not receive any intervention. Follow up assessments capturing study outcomes will be administered at 1 month (i.e., immediately post-intervention) and three months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age between 18 and 30 years
* Meet self-report criteria for tanning addiction
* Has access to the internet to complete study procedures
* Has personal mobile phone to complete study procedures

Exclusion Criteria:

* Male
* Age less than 18 or greater than 30
* Does not meet self-report criteria for tanning addiction
* Does not have access to the internet to complete study procedures
* Does not have a personal mobile phone to complete study procedures
Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

Post-dural puncture headache (PDPH) is a potential and debilitating complication of spinal anesthesia in pregnant patients undergoing caesarean sections (CS), with a reported incidence of 0.5%-2% .

Various methods for the management of PDPH are present including proper hydration, maintaining a supine posture, caffeine, paracetamol, nonsteroid anti-inflammatory drugs (NSAID), theophylline, opioids like morphine and fentanyl, with the only clearly effective treatment being the epidural blood patch.

Glass particle contamination is known to occur on opening single-dose drug ampoules. Although supporting data are lacking, intrathecal drug administration during subarachnoid blocks and chemotherapy with glass particle contamination is potentially hazardous,

Eligibility Criteria:
Inclusion Criteria:

* Parturient with American Society of Anesthesiologists (ASA) class I or II
* Age: 20-45 years old
* A full-term pregnant female undergoing elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Contraindications to regional anesthesia (coagulopathy, infection at the needle insertion site)
* History of Migraines or persistent headache
* Known hypersensitivity to local anesthetics
* Body mass index (BMI \> 35 kg/m2)
* Hypertensive disorders of pregnancy
* Emergency cesarean section
* Cardiorespiratory, hepatic, or renal impairment
* History of a cerebrovascular accident, neurologic or psychological disorders
* Uncontrolled hypertension
* Spinal column surgery, chronic opioid consumption
* Patients with more than one single attempt and patients with blood loss over 1000 mL who will need additional fluid supplementation or blood transfusion
* Patient refusal
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age, male or female
* 1-5 years after kidney transplantation
* The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
* The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
* At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
* gingival hyperplasia and treatment requested by the patient
* polytrichia and interventional therapy requested by the patient
* post-transplantation hypertension
* post-transplantation hyperlipemia (total cholesterol\>5.7 mmol/L (220 mg/dl))
* Serum creatinine\<200 μmol/l ( 2.3 mg/dl)
* A promise is made to take contraceptive measures during the study (women at childbearing ages).

Exclusion Criteria:

* Patients having accepted transplantation of other organs apart from kidney transplantation
* Patients with 24-hour urine protein\>2 g
* Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
* Patients with refractory infectious foci
* Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
* Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
* Patients allergic to tacrolimus or other basic medications
* Pregnant or lactating women
* Patients having participated in other clinical trials within the previous month
* Other patients who are considered by doctors unsuitable for the study
Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients

Pruritus, post traumatic stress disorder and perceived stress are common issues in burn patients. The correlation between the three is unclear so far.

This study will collect data among adult patients with hypertrophic scars 21 days after the burn event has occurred. Using a Chinese version of the 5D itch scale,Chinese version of the posttraumatic diagnostic scale and Perceived Stress Scale to investigate self-reported postburn pruritus,post traumatic stress disorder and perceived stress. The patients will be wearing the smart watch for one month to collect data on their stress levels. This data will be used to analyze the correlation between posttraumatic stress syndrome, perceived stress and scar pruritus. There will be two rounds of data collection. The first will be when the smart watch is issued to patients, and the second will be at the end of the one month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic scars 21 days after the burn event occurred
* Adult patients over 18 years old
* Patients without serious mental disorders, and are able to express themselves in Chinese with clear consciousness.
* The patient has no open wound on the wrist and is able to wear the smart watch continuously for one month

Exclusion Criteria:

* Patients with first-degree burns
* Non-traumatic electrical burns
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design

Phase I

* Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
* Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established

Phase II

* Step 1 (The patient inclusion may stop after this step):

  * Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL
* Step 2:

  * Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
* Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
* Evidence of platinum resistant or refractory disease
* ECOG Performance Status 0 - 1
* Life expectancy \> 3 months
* Signed informed consent (IC)
* Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
* Women of child-bearing potential must not become pregnant while participating in the study
* Adequate haematological and biological functions

Exclusion Criteria:

* Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
* Known brain metastases
* Another known active cancer within the last 5 years
* Radiotherapy to more than 30 % of bone marrow
* Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
* Concomitant treatment with a non-permitted medication
* A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
* Any serious concomitant systemic disorders incompatible with the clinical study
* Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
* Pregnancy or breastfeeding
* Known positive status for HIV and/or hepatitis B or C
* Drug and/or alcohol abuse
* Any reason why, in the investigator's opinion, the patient should not participate
Emergency Room Firearm and Medication Safety Intervention

Seventeen United States Veterans die by suicide each day. Nearly three-fourths of those Veterans die from firearm injury or poisoning, and many seek care in VA Emergency Departments (ED) prior to suicide attempts. In 2019, the VA began screening all Veterans seeking ED care for increased suicide risk. Interventions that promote firearm and medication safety are recommended for Veterans identified as at-risk. The investigators work will provide important information that will aid the development and testing of such an intervention for Veterans who seek care in VA EDs. The investigators will interview at-risk Veterans who recently sought VA ED care to identify factors relevant to developing the intervention, and work with Veterans and VA healthcare staff to develop and test an intervention.

Veterans will be recruited from the Rocky Mountain Regional VA Medical Center (RMRVAMC) ED who are identified as having elevated suicide risk by VHA's new suicide risk screening initiative. All Veterans visiting VHA EDs are screened using an eight-item version of the Columbia Suicide Severity Rating Scale (C-SSRS) Screener, a valid predictor of future suicidal behavior. The C-SSRS Screener assesses suicide risk using eight items about recent suicidal ideation and intent, preparatory behaviors, and action. Deductive and inductive content analysis of qualitative interviews will occur in parallel with recruitment, and participants will be recruited until thematic saturation is achieved.

Veterans' visits (approx. 90 minutes) will be scheduled at their preferred times at RMRVAMC within two weeks of discharge from the ED. Sociodemographic and military service data will be collected using the Rocky Mountain Mental Illness Research, Education, and Clinical Center (MIRECC) Demographics Survey. During this visit, individuals will participate in qualitative interviews to identify contextual factors that may inform development of VA-based lethal means safety interventions.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Recent Emergency Room care
* Screen positive for elevated suicide risk

Exclusion Criteria:

* Severe cognitive impairment
* Lack decisional capacity
* Unable to provide informed consent
* Lack reliable phone access
* Admitted to the hospital
A Clinical Simulation Study of a Test Material on the Anterior Nares

The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female between 18 to 55 years of age;
2. Subject has normal nasal passage;
3. Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
4. Subject is willing to have materials applied and follow the protocol;
5. Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
6. Subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
7. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
8. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
9. Subject is willing to participate in all study evaluations;
10. Subject is in generally good health;
11. Subject understands and is willing to sign an Informed Consent Form

Exclusion Criteria:

1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
3. Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
4. Subject reports a history of allergies to antiseptics;
5. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
6. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)

Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, of either sex, and of any race.
* Must have active or fistulizing CD and must have experienced at least 1 of the following:

  * failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy
  * required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy
  * luminal or fistulizing CD, which, in the treating physician's judgment, qualifies for initiation of Remicade.
* Willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
* Must be evaluated for active and inactive (latent) tuberculosis (TB) at the Baseline Visit. TB evaluation will consist of TB history questions (eg, medical history, possible previous contact with TB, TB vaccination history). TB evaluation and TB screening (eg, skin test, chest x-ray) are required when a subject starts treatment with Remicade. In these cases, subjects must be screened for TB within 3 months prior to initiating Remicade treatment.

Exclusion Criteria:

* Female who is pregnant or nursing.
* Treated with Remicade prior to Baseline.
* Previously treated with other tumor necrosis factor (TNF)-active agents and other investigational drugs for CD prior to Baseline.
* Active or untreated latent TB or other severe infections such as sepsis, abscesses, or opportunistic infections.
* Moderate or severe heart failure (New York Heart Association \[NYHA\] Class III: subjects with marked limitation of activity; they are comfortable only at rest/Class IV: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
* Have lymphoproliferative disorders (eg, lymphoma) or malignancies.
* In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
* Are participating in any other clinical trials (excluding registries).

In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met:

* Females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with Remicade and to continue its use for at least 6 months after the last Remicade treatment.
* History of hypersensitivity to murine proteins or to any excipients of Remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate).
* Other conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC).
Comparison of the Effects of Different Exercise Types

This study perform to investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance.

The choice of exercise type is affected by many different factors. The purpose of exercise and the physical fitness parameter they want to develop gain importance in this choice.

Resistance exercises (RE) specifically designed to increase muscle strength and hypertrophy; Plyometric exercises (PE) based on energy storage of the muscle during the deceleration phase and release of this energy during the acceleration period and high-intensity interval training (HIIT), which is an advanced form of interval training that includes shorter and lighter recovery periods following short to heavy anaerobic exercise are some of the many types of exercises in the literature and practice.

The purpose of the study is investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance.

Eligibility Criteria:
Inclusion Criteria:

1. Being 18-30 years old
2. Being a man
3. Volunteering to participate in the study
4. Having a normal BMI (18.5-24.9) according to the World Health Organization criteria

Exclusion Criteria:

1. Having any physical, mental or psychological illness that may affect participation in the study
2. Having a history of trauma to the lower extremity requiring medical, conservative and surgical treatment in the last 6 months
3. Consuming alcohol or pharmaceuticals up to 24 hours before the assessment