cyrilzakka/clinical-trials huggingface dataset:
Prolonged Emend in a Study (NYU 03-67) of Oxaliplatin and Topotecan in Previously Treated Ovarian Cancer

The investigators propose to totally abolish the emesis (vomiting) associated with the regimen of oxaliplatin + topotecan by adding a daily administration of aprepitant (Emend) for 17 days to the HT3 blocker routinely given on days 1 and 15.

Patients enrolled in NCT0031361, NYU 03-67 (A Phase II study of Oxaliplatin combined with continuous infusion topotecan as chemotherapy for patients with previously treated ovarian cancer NCI #6317) will receive oxaliplatin 85mg/m2 as a 2-hr IV infusion on D1, 15 and topotecan 0.4mg/m2/day as a continuous infusion for 14 days beginning on D1 (D1-15) on a 4 week cycle.

On days 1 and 15 of the first cycle, patients will also receive IV ondansetron 32 mg and 10mg of dexamethasone. Emend 125 mg will be given on day 1; on days 2-17, patients will be given daily oral 80mg Emend without dexamethasone.

On cycles 2-6 patients opting to continue to receive Emend as above: Emend 125 mg will be given on day 1; on days 2-17, patients will be given daily oral 80mg Emend without dexamethasone.

Following cycle 1, Emend will be given in its conventional schedule (i.e., d 1-3, and d 15-17) unless after discussion with the Principal Investigator, the patient's request to receive drug as in cycle 1 is deemed desirable and safe to enter the optional extension arm.

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilling the requirement for entering the study NYU 03-67 will be eligible to enter the supplementary protocol with Emend. Please see NCT0031361 for eligibility.

Exclusion Criteria:

* Patients not enrolled on NYU 03-67(NCT0031361).
ECGI in Patients With Persistent Atrial Fibrillation

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.

The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine:

* The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF.
* The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE).
* If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system.
* The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI

Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months.
* Patients who are symptomatic
* Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic

Exclusion Criteria:

* Patients under 18 years or over 85 years of age.
* Patients with chronic alcoholism.
* Recent myocardial infarction within one month of the study.
* Significant debilitating diseases or a terminal disease.
* Patients with documented left atrial thrombus.
* Medical or mental conditions precluding a long-term follow-up.
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients with Non-hypovolemic Non-acute Hyponatremia

This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in each group) patients are to be enrolled randomly into Tolvaptan group or placebo group. Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while those in control group receiving standard therapy + placebo. The starting dose of tolvaptan is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg according to a certain titration scheme based on patients' response of serum sodium level. The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed as secondary efficacy variables.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent.
2. Age:18～75 (when informed consent is obtained)，male or female.
3. Non-hypovolemic and non acute hyponatremia with a Serum sodium \< 135mEq/L before randomization. (main underlying diseases include CHF, hepatic cirrhosis with edema, SIADH and others)
4. In-patient subjects.
COVID-19 Observational Research Collaboratory

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2 using electronic health record information and structured surveys.

Background: Early evidence suggests that the frequency and type of long term complications stemming from SARS-CoV-2 infection may depend on the severity of initial presentation. However, additional unidentified factors may also play a role including those related to the individual, the environment and/or the specific strain of the virus. The long-term health impacts of SARS-CoV-2 will have major implications for health care utilization, care processes and quality and costs of care for Veterans, both within the VA and in the community. Over 200,000 Veterans have had COVID-19. Although the long term consequences of this novel illness are unknown, it is clear they will often be significant. The overarching goal in the Long-Term Outcome Study (LTO) is to advance VA HSR\&D research into the consequences and care of COVID-19 infection by developing and releasing integrated multi-modal data and results on long-term outcomes of COVID for use by VA clinical, research and operations communities. The investigators will do so via a coordinated program of data production and analysis using the VA electronic health record (EHR) and other administrative sources (e.g., Medicare), de novo longitudinal survey, and qualitative inquiry. This work will be closely coordinated with the COVID-19 Observational Research Collaboratory (CORC) Coordinating Center (CCC) and the burgeoning community of HSR\&D-funded COVID researchers.

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2.

Aim 1: Using VINCI-CDW data, patients will be identified who had a SARS-CoV-2 test since February 2020. The investigators will use a combination of traditional epidemiologic studies, and machine learning algorithms to determine the long term, multi-systemic and functional adverse outcomes and/or syndromes related to SARS-CoV-2. Members of the research team are currently developing methods to identify new onset and exacerbations in comorbidities following SARS-CoV-2 illness in Veterans.

Aim 2: Determine Veteran-Reported Outcome Effects Using Structured Survey on domains such as self- reported symptoms, disability, and financial impacts, measured repeatedly over 36 months.

Eligibility Criteria:
Inclusion Criteria:

All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

Exclusion Criteria:

VA employees
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
* Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
* Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
* Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Key Exclusion Criteria:

* Known hypersensitivity to the study drug
* Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
* Use of prohibited concomitant medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Investigation of Efficiency of Breathing With Different Breathing Patterns

Our aim in this study is to investigate the efficiency of the breathing with different breathing patterns. Ten volunteers and twenty patients having respiratory problems will be coached on their breathing through specific masks which will provide four different breathing patterns. These patterns will be 1) Breathing in through the nose only and out through the mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing in and out through the nose only 4) Breathing in and out through the mouth only The data obtained from volunteers and patients will be compared within and between the groups.


Eligibility Criteria:
Inclusion Criteria:

* For healthy subjects:

  1. Ten healthy adult (\> 18 years of age) volunteers will be recruited from the MGH main campus through intra-hospital e-mail broadcasting. Subjects with the following issues will be excluded from the study.
* For patients with respiratory insufficiency:

  1. Twenty adult (\> 18 years of age) patients will be recruited. These patients will be either patients in acute respiratory failure resulting from COPD exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the MGH; or patients with diagnosed stable COPD on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the MGH as study subjects.

Exclusion Criteria:

* For healthy volunteers:

  1. Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
  2. Subjects who have claustrophobia and cannot wear the mask.
* For patients with respiratory insufficiency:

  1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
  2. Patients who have claustrophobia and cannot wear the mask.
  3. Patients who are hemodynamically unstable.
  4. Patients requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers

The purpose of this study is to investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture
* The subject belongs to skin type II or III according to Fitzpatrick skin type scale
* Females must have a negative pregnancy test at screening and at admission, must not be lactating and must be of non-child-bearing potential
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product.

Exclusion Criteria:

* Presence of skin disorders, tattoos or other skin conditions that may interfere with the QST measurements, as judged by the Investigator
* Recent exposure to significant amount of UV light, as judged by the Investigator.
* Use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives.
* History of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3161.
* Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening
Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel

The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel.

The main objective of this study is to evaluate the efficacy of ibuprofen 50 mg/g gel in the treatment of patients with muscle, joint pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid 25mg/g gel.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, of any race, aged 12 years;
* Ability to read, understand and sign the Informed Consent in the case of minors monitoring and consent of a parent;
* Complaint of clinical muscle pain, joint pain caused by sprains, contusions, tendonitis, or myofascial;
* Score more than 4 VAS symptom reviewed: Pain;
* Patients able to understand and follow the protocol of the trial.
* Patients with or without ligament injury ligament injury partial and incomplete

Exclusion Criteria:

* Known hypersensitivity to components of the formula, both the medication and the comparative test;
* Hypersensitivity to acetylsalicylic acid;
* Hypersensitivity to ketoprofen, ibuprofen or other anti-inflammatory steroid;
* Hypersensitivity to acetaminophen;
* Skin changes in the pathological site of application, such as eczema or acne, or infected skin or wound;
* Pregnant or lactating women.
* Patients who require surgery or immobilization;
* Patients with fractures or ligament rupture;
* Patients taking anticoagulants;
* Patients with decompensated concomitant systemic diseases, such as diabetes, congenital or acquired blood disorders, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders;
* Use of NSAIDs, corticosteroids or venotherapics, threads or any other form of administration;
* History of alcoholism or substance abuse;
* Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma

Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma.

The objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe/refractory asthma presenting other respiratory disease,
* ≥ 18 years of age,
* using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent)
* FEV1\<60%,
* regular visitor of the pharmacy and the physicians.

Exclusion Criteria:

* participation in other intervention study during this study,
* living in other cities,
* could not participate in all visits of the study
Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.

This study aims to evaluate the effectiveness of an intervention to help people to quit smoking throughout an chat bot compared with usual assistance to increase long-term rates of nicotine abstinence in smoking outpatients with biochemical validation at 6 months.

Half of participants(control group) will receive usual care by their usual general practitioners and nurses, and the other half (intervention group) will use an evidence-based chat bot specifically designed to help people quit smoking.

An array of interventions have been shown to be both cost-effective and efficacious in helping patients quit smoking and so are included in usual care given by general practitioners and nurses. However, in the primary care setting, this sort of interventions are less common than they should be, due to many circunstances, and solutions must be found due to the huge dimensions of tobacco use challenge.

On the other hand,new kinds of information tecnology give a chance to intervene with less costs and more specific tools. Actually, there are a lot of mobile apps and other devices designed to help people to improve their health in many ways, but without scientific evidence of their effects.

This is a pragmatic, randomised, controled and multicentric clinical trial that tries to evaluate in general population the effectiveness of a chat bot that incorporates evidence based interventions and interacts by a text application instaled in patients mobile phone (intervention group).

Investigators have decided to compare with usual care delivered by the usual general practisioners and nurses of Spanish Public Health Centres, because this interventions have shown their effectiveness (control group).

Efficiency and impact on quality of life will also be compared on both groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* Smoked more than one cigarette per day last month.
* Accepts help to quit smoking next month.
* Owns a mobile phone with the ability to install a messaging application.
* Does not anticipate changing address in the next 6 months.
* Understands spoken and written spanish language.
* Accepts to participate and signs the informed consent.

Exclusion Criteria:

* Communicative barriers.
* Addiction to other substances.
* Participation in another cessation program or other clinical trial during the study period.
Effects of High-Intensity Functional Training on Physical Fitness and Jumping Difficulty Movement

While prior research indicates the efficacy of High-Intensity Functional Training (HIFT) in improving physical fitness and skill performance across various sports , its effects on Wushu routine athletes still need to be determined. This study aims to explore the impact of high-intensity functional training on the physical fitness and jumping difficulty of Wushu routine athletes, providing valuable insights for coaches and athletes to optimize training plans. Coaches or sports researchers can use this knowledge to manage the training load of athletes better, thereby helping Wushu athletes achieve better results in Wushu jumping difficulty movements training.

In this study, the intervention design part of the researchers referred to Greg Glassman's (2010) "CrossFit training guide" and designed a high-intensity functional training program based on the characteristics of wushu routines . This study employs a Cluster Randomized Controlled Trial (CRCT) design. The experimental period of this study is 12 weeks, three times per week. The training lasts 1.5 hours, including one hour of physical fitness training and half an hour of specialized technical training. The sample for this study is male Wushu routine athletes from the Hebei Institute of Physical Education and Hebei Normal University, with 60 participants. Athletes were randomly assigned to two different training locations and divided into experimental and control groups. The specialized skills training content of the two groups is the same, with the only difference being the physical training part. The experimental group received high-intensity functional training, while the control group maintained routine training. In addition, the specific content of routine training for the control group is the school's standard training plan. The dependent variables to be measured in this study are physical fitness (strength, power, speed, endurance, and flexibility) and jumping difficulty movements (Flying Kick, Whirl Wind Kick, Outward Leg Swing in Flight, and Side Somersaults). This study measured the dependent variable three times throughout the intervention: baseline before the experimental intervention, post-test 1 after 6 weeks, and post-test 2 after 12 weeks. Finally, statistical analysis was conducted on the three test results.

Eligibility Criteria:
Inclusion Criteria:

* Male.
* Aged 18-23 years old.
* Health.
* No experience of high-intensity functional training.

Exclusion Criteria:

* Athletes with physical surgery.
* Have high-intensity functional training experience.
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements

Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.

1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.

Hypothesis: Maintaining vitamin D levels \>30 ng/ml will decrease HbA1c and insulin requirements.

New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of \<30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type I DM.
* Age \<18 years

Exclusion Criteria:

* Pregnancy