cyrilzakka/clinical-trials huggingface dataset:
The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Diseases

The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.

This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* aged 40 years or older, with physician-diagnosed COPD
* a flow volume loop with a FEV1/FVC of \< 0.70 in the past 12 months

  * medically cleared to participate in NYULMC's pulmonary rehabilitation program.

Exclusion Criteria:

* Inability to exercise due to musculoskeletalor neurological dysfunction
* Inability to walk independently (unaided)
* deafness or severe hearing impairment requiring hearing aids
* mMRC score = 0 ("I only get breathlessness with strenuous exercise").
Pre-hospital Post ROSC Care: Are we Achieving Our Targets?

Rational: Out of hospital cardiac arrest is a devastating event with a high mortality. Survival rates have increased over the last years, with the availability of AED's and public BLS. Previous studies have shown that deranged physiology after return of spontaneous circulation (ROSC) is associated with a worse neurological outcome. Good quality post-arrest care is therefore of utmost importance.

Objective: To determine how often prehospital crews (with their given skills set) encounter problems meeting optimal post-ROSC targets in patients suffering from OHCA, and to investigate if this can be predicted based on patient-, provider- or treatment factors.

Study design: Prospective cohort study of all patients attended by the EMS services with an OHCA who regain ROSC and are transported to a single university hospital, in order to identify those patients with a ROSC after a non-traumatic OHCA who had deranged physiology and/or complications from OHCA EMS personnel was unable to prevent/deal with in the prehospital environment.

Study population: Patients, \>18 years, transported by the EMS services to the ED of the University Hospital Groningen (UMCG) with a ROSC after OHCA in a 1 year period

Main study parameters/endpoints: Primary endpoint of our study is the percentage of OHCA patients with a prehospital ROSC who arrive in hospital with either a deranged physiology or with complications from OHCA EMS personnel was unable to deal with.


Eligibility Criteria:
Inclusion criteria:

* Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital
* Age \> 18

Exclusion criteria:

* Traumatic cause of arrest (NB asphyxia due to hanging, electrocutions and drowning are not considered as traumatic arrests in this study, as normal ALS algorithms (special circumstances) are followed for these patients
* No ROSC before leaving OHCA
* Age \<18
* Informed opt out of medical research of patient
A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome

The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10\^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10\^6 after pretreatment into 2 x 10\^6 or higher and \< 2 x 10\^6 groups, and will further divide \< 2 x 10\^6 group into: = 0, (0,10\^6\], (10\^6, 2 x 10\^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.


Eligibility Criteria:
Inclusion Criteria:

* infertility female and sterility male for reproductive treatment

Exclusion Criteria:

* chromosomal abnormalities
* none retrieval oocyte
* none oocyte for ICSI
* Recurrent abortion
* female age≥37 years
* Assisted hatching
* abnormal oocyte zona pellucida
* In Vitro Maturation
* AZF microdeletion
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of narcolepsy
* Good general health
* Willing and able to comply with the study design and schedule and other requirements

Exclusion Criteria:

* If female, pregnant or lactating
* Customary bedtime later than midnight
* History of significant medical condition, behavioral, or psychiatric disorder (including suicidal ideation), or surgical history
* Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
* History of significant cardiovascular disease
* Body mass index \> 34
* Excessive caffeine use - \> 600 mg/day of caffeine or \> 6 cups of coffee/day
* History of alcohol or drug abuse within the past 2 years
* Nicotine dependence that has an effect on sleep
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans

In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration.

Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 year
* polyarthritis
* DAS score \> 2.5

Exclusion Criteria:

* previous use of MTX
* concomitant use of dipyridamole/sulfazalasine
* Alcohol \> 21 U/week
* elevated liver enzymes
* pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia
Personalized Advance Prescriptions in Palliative Care at HOME: Interests and Difficulties of Its Implementation

Retrospective data collection on the files of patients cared for by the mobile palliative care team of the William Morey Hospital Center who died in 2022.

Retrospective selection of patients and collection of data : pathology, identified risk, presence of caregiver, end-of-life wishes, characteristics of palliative care treatment, circumstances of death. Comparison of two groups : presence or absence of personalized advance prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years old
* Taken care of once in their place of life by a palliative care team
* Died between 01/01/2022 and 12/31/2022 in William Morey Hospital Center

Exclusion Criteria: none
Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.

The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 3 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Simple knee medial compartment osteoarthritis High tibial osteotomy.
2. With varus deformity, medial proximal tibia angle \<85°
3. Unilateral High tibial osteotomy
4. informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

1. patients who underwent other knee surgery within 6 months
2. Preoperative combined anemia (Hb\<100g/l)
3. Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
4. Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.
Danhong Injection in the Treatment of Unstable Angina Pectoris

The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.


Eligibility Criteria:
Inclusion Criteria:

* Female or male inpatients.
* Age: 35 - 75 years.
* Patients with clinical diagnosis of unstable stable angina according to China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association, including one of the following conditions.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in UA ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is a 6-item questionnaire including the symtoms as following: (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

* Patients with severe heart failure (EF\<35%);
* Patients with history of infection, fever, trauma, surgery(exclude PCI) and inflammation in the past month;
* Patients with active tuberculosis or rheumatological disorders;
* Patients with renal dysfunction (Male: CCr\>2.5mg/dl; Female: CCr\>2.0mg/dl);
* Patients with liver dysfunction (any value of serum aminotransferase more than triple normal value);
* Patients with history of hematopoietic system diseases;
* Patients with mental disorder;
* Patients with history of drug-induced bleeding or history of bleeding caused by warfarin;
* Patients with malignant tumor;
* Patients with history of organ transplant;
* Woman with pregnancy, lactation or positive result of pregnancy test;
* Patients who is participating in other trials or has been participated in other trials in recent 3 months;
* Patients who were unable to participate in the study as judged by investigator.
Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery.

The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside.

The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included


Eligibility Criteria:
Inclusion Criteria:

* Undergoing curative intended surgery for colon or rectum cancer
* UICC stage I-III

Exclusion Criteria:

* Neoadjuvant oncological treatment
* Acute / subacute surgery
* Palliative surgery
* Other pathology than adenocarcinoma
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.

The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.


Eligibility Criteria:
Inclusion Criteria:

* Well-characterized epileptic syndrome according to the ILAE classification.
* Patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period.

Exclusion Criteria:

* History of status epilepticus in the last year.
* Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration.
* Subjects with a creatinine clearance of ≤50 mL/min.
Long-Term Follow-Up Study of Human Stem Cells Transplanted in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)

The purpose of this study is to determine the long term safety and preliminary effect of HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).

Only subjects who underwent HuCNS-SC transplantation under Protocol CL-N01-PMD will be enrolled in this long term follow-up study.

Subjects will return to the site six months and one year after completion of the Phase I study and then annually for a total study duration of four years. Phone calls will also be made by the Investigator to the subject's parent/legal guardian bi-annually to conduct a phone visit through the four-year duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received HuCNS-SC cells under Protocol CL-N01-PMD

Exclusion Criteria:

* Subjects who received off-protocol immunosuppressive medications.
* Subjects who are concurrently enrolled in another investigational study.
Optimizing Fitness: Post Bariatric Surgery With Modified Qigong Breathing Exercise

Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery. This study was conducted to explore the influence of Modified Qigong Breathing Exercise on pulmonary function, endurance and fitness on post bariatric surgery patients.

Qigong as ancient Chinese traditional medicine have been documented to be effective in treating obesity. Literature showing that the desire to eat and the feeling of hunger, along with prospective food consumption in patients with obesity.

Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery. This study was conducted to explore the influence of Modified Qigong Breathing Exercise on pulmonary function,endurance and fitness on post bariatric surgery patients.

Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.

Qigong as ancient Chinese traditional medicine have been documented to be effective in treating obesity. Literature showing that the desire to eat and the feeling of hunger, along with prospective food consumption in patients with obesity .

Eligibility Criteria:
Inclusion Criteria:

* Both male and fem
* age ranged from 18-25 years old
* at least 6 months after BS

Exclusion Criteria:

* Patients with nerve root compression
* spine disorders
* spinal fracture
* previous spinal surgery
* pregnancy
* lower limb injury
* Any contraindication to the exercise therapy
A Study of ZL-1310 in Participants With Selected Solid Tumors

A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors

This is an open-label, multiple-center, phase Ib/II study of ZL-1310 in selected solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Adult men and women ≥18 years of age
* Participants must have histologically confirmed, locally advanced or metastatic NECs, and must have experienced disease progression on or after platinum-based therapy
* Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
* Participants must have at least one measurable target lesion as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
* Clinically active central nervous system (CNS) metastases
* Participants with leptomeningeal metastasis
* Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
* Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
* Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis
* Major surgery within 4 weeks of the first dose of study treatment
* Hypersensitivity to any ingredient of the study treatment
* Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
* Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
* Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
* Pregnant or nursing (lactating) women
* Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer