cyrilzakka/clinical-trials huggingface dataset:
Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

To evaluate the safety and efficacy of the phase 1 cardiac rehabilitation protocol(HRN4HTx) in heart transplant patients, focusing on self-care capacity and functionalrecovery.

Type of study: Descriptive and Interventional Study

- Location: Centro Hospitalar e Universitário de Coimbra, Cardiothoracic Surgery Unit

Study Population:

* Inclusion Criteria: Heart transplant patients, over 18 years of age, capable of providing informed consent.
* Exclusion Criteria: Rejection 2R, inability to understand due to cognitive impairment, external ventricular assistance, infectious processes with hemodynamic changes.

Intervention:

The HRN4HTx protocol was implemented during hospitalization, divided into five progressive stages according to FITT parameters and international recommendations. Interventions included respiratory exercises, calisthenics exercises, balance training, resistance exercises for upper and lower limbs, and walking.

Adverse Event Monitoring:

Adverse events (AEs) and serious adverse events (SAEs) were monitored according to Good Clinical Practices. Examples of monitored events include arrhythmias and significant changes in blood pressure.

Outcomes Measured:

* Self-Care Capacity: Barthel Index measured at admission and discharge.
* Functional Capacity: 6-minute walk test (6MWT) conducted at discharge.
* Knowledge of Risk Factors: Evaluation of knowledge regarding alarm signs and cardiovascular risk factors at discharge.

Ethical Approval:

This study was approved by the Ethics Committee of the Centro Hospitalar e Universitáriode Coimbra (Protocol No. OBS.SF.111/2021). All participants provided written informed consent prior to participation.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patients, over 18 years of age, capable of providing informedconsent.

Exclusion Criteria:

* Rejection 2R
* Inability to understand due to cognitive impairment
* External ventricular assistance
* Infectious processes with hemodynamic changes
Methods for Nutritional Assessment in Cirrhosis

Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.

Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis
* No restriction of etiology
* 18-75 years
* Child-Pugh stage A/B/C
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Extremity amputation
* Malignancy different from hepatocellular carcinoma
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC

China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.

This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatocellular carcinoma
* Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib)
* Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc)
* Treated Treated with ICIs plus TKIs and local therapy
* Have complete medical record that can complete the OR or 1 year OS assessment and follow-up.

Exclusion Criteria:

* Patients who do not have complete medical record and follow-up information after treatment；
* The researchers have evidence that it is not suitable for this study
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must sign the informed consent.
2. The patient must sign the informed consent of genetic screening test.
3. The patient must be between 18 years old and 80 years old who can make a decision independently.
4. The patient must be post-menopause status.
5. The patient should be the stage 1,2 or 3 of the breast cancer.
6. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).

Exclusion Criteria:

1. The patient is pre-menopause status.
2. The test result of serum FSH level is below 30mU/ml.
3. The test result of the hormone receptor(ER \& PR) is negative or unknown.
4. Patient's breast cancer stage is 4 which has systemic metastatics.
Neurophysiology of Prophylactic Treatment in Migraine

This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.

The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.


Eligibility Criteria:
Inclusion Criteria (migraineurs):

* episodic migraine according to ICHD (international classification of headache disorders)-3 criteria
* headache documented over at least 3 months through a headache calender
* scheduled for prophylactic therapy of their migraine

Exclusion Criteria (migraineurs):

* history of chronic migraine
* current medication-overuse headache
* neurological or psychiatric diagnosis other than headaches
* chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.)
* contraindications for magnetic resonance imaging
* contraindications for transcranial magnetic stimulation

Inclusion criteria (controls):

* not more than 3 years younger or older than matched control
* gender similar to matched control
* menstrual cycle equal to matched control (if female)

exclusion criteria (controls):

* more than 1 headache day/month
* history of migraine
Cervical Nags Effect on Accessory Muscles

The aim of this work is to record changes on accessory muscles especially sternocleidomastoid and scalene after applying cervical NAGs in COPD patients.

Natural gliding movements in the spine, known as apophyseal glides, occur during breathing. These movements are believed to be important for maintaining good posture and flexibility in the spine. In COPD patients, the muscles that support the spine, like the scalene and SCM, can become tight and strained due to labored breathing. This tightness can lead to neck and shoulder pain.

While studies suggest that natural apophyseal glides improve spinal mobility, accessory muscle flexibility and reduce pain, there is room for further research on COPD patients, especially in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Registered with history of moderate (II) to severe (III) grade COPD (for a minimum of 1 year) will be included in the study.
* Patients who are clinically stable.

Exclusion Criteria:

* Patients who have any pre-existing cervical spine disease.
* Patients who have any cardiac disease.
* Other respiratory co-morbidities
* Patients who have severe dizziness or coughing
Transcutaneous Spinal Cord Stimulation in Healthy Adults

The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.

Investigators will use a test-retest design comparing neurophysiologic measures while receiving various combinations of stimulation waveforms, modulation frequencies, and stimulation locations to determine the settings which lead to the highest participant tolerance with the lowest lower extremity resting motor thresholds (RMTs).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old
* Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

* History of stroke or neurologic pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
* Pregnant or nursing
* Skin allergies or irritation; open wounds
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
* History of seizures or epilepsy
* Active cancer or cancer in remission less than 5 years
* Metal implants in the back or spine
* Painful musculoskeletal dysfunction due to injury or infection
* Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
A Community Partnership to Treat Stroke

Getting to the hospital quickly is the key to treating stroke. African Americans suffer more strokes with worse outcomes and receive stroke treatments less often than European Americans. This project will work to reduce these health disparities by creating and testing the feasibility of a peer-led faith-based behavioral intervention in an African American community with a goal to increase calls to 911 so stroke patients can be treated quickly.


Eligibility Criteria:
Inclusion Criteria:

To meet participant eligibility criteria, individuals must be 18 years of age or older (adult intervention) or between 10-17 years of age (youth intervention), a resident of the Flint or greater Flint community, and English speaking.

Exclusion Criteria:

We will attempt to exclude those who cannot read English because they will not be able to benefit from the intervention materials. These criteria will be confirmed during assessment procedures prior to enrollment.
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic

The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.

This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.

Both parents provided informed written consent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants with a gestational age ranging from 37 to 42 weeks
* Non breastfed children
* Infants with normal growth
* Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
* These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
* Apgar score \> 5 to 7 minutes

Exclusion Criteria:

* Infants with severe regurgitations
* Newborn currently participating in another trial
* Infants presenting a metabolic, nervous or organic disease able to interfere with the study
* Infants presenting lactose intolerance
* Evidence of protein cow's milk allergy
* Mother who wants to keep breasfeeding
Hydrocortisone Use During Peri-operation for Pituitary Adenomas

The investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.

Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved.

Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed.

For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact
* Patients of either gender aged from 18 years to 70 years

Exclusion Criteria:

* Patients with Cushing's disease
* Patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery
* Patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery
* The postoperative pathology result indicates that the tumor is not a pituitary adenoma
* Patients that refuse to participate in the study or those who ask to quit after enrollment
Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.

In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection.

Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.


Eligibility Criteria:
Inclusion Criteria:

* stable Angina (CCS \>1-3) with suspected CAD or
* dyspnoea at exertion NYHA \>2 or
* signs of ischemia within SPECT or exercise electrocardiography
* willingness to participate in the trial

Exclusion Criteria:

* Unstable angina or myocardial infarction within the last 2 weeks
* inability to perform bicycle exercise test
* significant valvular disease
* HOCM
* av- block \>I degree
* asthma bronchiales
Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection.

Other authors described how none of the elderly patients receiving antihistamines and azythromycin in two nursing homes in Toledo -Spain- during the first wave died or needed hospital admission, even considering that 100% of residents had a positive serological test after that wave. Other authors have described a positive evolution in patients receiving amantadine for their Parkinson's disease.

The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving these treatments showed a better evolution.

The number COVID cases would be related to hospital admissions. Among hospital admissions, the number of previous treatments, the length of admission, the need or not of the Intensive Care Unit (ICU) and their final status (survivors or non survivors) would be studied.

If patients that previously received the influenza vaccine or treated with ACEI, ARB, antihistamines or amantadine showed a better evolution, it would be proposed to extend vaccination and the inclusion of ACE inhibitors, ARB, antihistamines or amantadine in the treatment of infection.

Eligibility Criteria:
Inclusion Criteria:

* Hospital Admissions at the Hospital of Terrassa from March 1, 2020 for any cause.

Exclusion Criteria:

* None.
* For comparison of percentage of Influenza vaccination, ACEI and ARB vs general population, patients from outside the reference area of the Terrassa Health Consortium would be excluded.
Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.

This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.

After the adjustment of fertility policy in China, the prevalence of advanced maternal age (AMA) has become a crucial issue in maternal health care. AMA can greatly increase the risk of gestational diabetes mellitus (GDM) during pregnancy. However, there is still a lack of high-quality evidence on GDM preventive interventions for AMA pregnancy in China.

In this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on GDM in AMA pregnancies. The investigators will enroll a total of 346 singleton pregnant women in Peking University First Hospital and randomly assign them to either the intervention or control group. Information of maternal characteristics will be obtained at recruitment. At each prenatal visit, weight and blood pressure of all participants will be measured. For each participant, fasting venous blood samples will be collected at \<14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. The primary outcome is the incidence of GDM. The secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.

Eligibility Criteria:
Inclusion Criteria:

* local resident in Beijing
* Singleton pregnancy
* Aged ≥35 years
* Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
* ≤12 weeks of gestation
* written informed consent is obtained

Exclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes before pregnancy
* Diagnosed with GDM or impaired glucose tolerance at enrollment
* use of medication that influences glucose metabolism currently, such as metformin, etc.
* multiple pregnancy
* current substance abuse
* unable to exercise due to physical disability
* diagnosed severe psychiatric disorder
* Other conditions not suitable for intervention as judged by physicians
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* ECOG PS 0-1
* Curative surgery (R0 resection)
* ypStage III B and ypStage III C
* No distant metastasis after surgery

Exclusion Criteria:

* any treatment before surgery including chemotherapy, radiotherapy and targeted agents.
* Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
* Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
* Heart failure grade III/IV (NYHA-classification).
* Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
* Subjects with known allergy to the study drugs or to any of its excipients.
* Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
* Breast- feeding or pregnant women
* Lack of effective contraception
Allergic Transfusion Reactions in Plasma Transfusion

Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.

Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire .

In-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving plasma transfusion

Exclusion Criteria:

- Patients not able to complete sampling procedure