cyrilzakka/clinical-trials huggingface dataset:
Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation Because of COVID-19

This study applied the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) on respiratory patients who had their on-going ambulatory Pulmonary Rehabilitation program interrupted due to the COVID-19 outbreak. The research hypothesis is that ranking patients' self-efficacy is a useful screening tool to support patients' follow-up on a Pulmonary Rehabilitation telehealth solution to be explored during the COVID-19 outbreak.

This was an observational study applied to a convenience sample of Pulmonary Rehabilitation outpatients from Hospital Pulido Valente in Lisbon, Portugal, which had ambulatory treatments suspended due to the COVID-19 outbreak. Cross-sectional design was operationalized by a physiotherapist who promptly screened by phone a sample of 100 patients, assessing 90% of the eligible population. Patients had no previous therapeutic relation with the physiotherapist, who was also blind to patient's status at the Pulmonary Rehabilitation program. The screening call took a mean time of 484.8 ± 173.6 seconds, which is proximately about 8 ± 3 minutes per patient, with a minimum of 5 and a maximum of 19 minutes. Screening process included applying the Portuguese version of the Pulmonary Rehabilitation Adapted-Index of Self-Efficacy (PRAISE) and also included questioning patients if they were engaging on a daily routine of respiratory exercises by their initiative, and also if they managed to preserve a daily period to practice physical activity. In case of a positive answer, information concerning available equipment and exercise protocol adopted at patient's home environment was also collected. On a subsequent phase, data about patients' age, diagnosis referral for Pulmonary Rehabilitation, number of completed treatment sessions and weekly frequency, was collected from the hospital information system. Statistical analysis and data management were performed using the Statistical Package for the Social Sciences (SPSS) version 25.0 (SPSS Inc., Chicago, IL, USA). A formal sample size was not calculated since this was a convenience sample of 100 patients. Descriptive statistics included mean, standard-deviation, median, quartiles, range, minimum and maximum values and frequencies presented as percentages. Inferential statistics included the Pearson coefficient for PRAISE, age and number of treatment sessions, with the remaining variables analysed by the Spearman coefficient. PRAISE was the primary outcome, with mean comparison analysed by the Student t test, proved the normal distribution and equal variances. A p value of less than 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute respiratory disease
* Patients with chronic respiratory disease
* Patients attending a hospital-based Pulmonary Rehabilitation program

Exclusion Criteria:

* Cognitive deficit for answering a questionnaire
Remote Ischemic Conditioning for Parkinson's Disease

The purpose is to evaluate feasibility and efficacy of Remote Ischemic Conditioning(RIC) as adjuvant therapy for Parkinson's Disease(PD). Sixty patients will be randomized into 2groups: RIC group receiving Remote Ischemic Conditioning except conventional therapy（n=30）and control group with conventional therapy (n=30).

Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms to above systolic pressures (mmHg). This procedure induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. RIC has been shown to improve outcomes in patients with heart attacks, strokes, but is not investigated for PD. We argue that RIC may exert neuroprotective effect on PD due to its multiple mechanisms. The aim of the study is to evaluate the impact of RIC on long term outcomes in patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 - 70 years;
* diagnosed with idiopathic PD;
* a rating of 1-3 on the Hoehn and Yahr Scale;
* On optimized dopaminergic therapy for 4 weeks prior to enrollment;
* Be able to complete the research scale evaluation;
* sign informed consent.

Exclusion Criteria:

* Atypical Parkinsonism or other significant brain conditions such as a stroke;
* Significant mental disease or psychosis;
* History or presence of significant peripheral vascular disease in the upper limbs;
* Presence of skin ulceration to the arms;
* Deep Brain Stimulation ( DBS);
* Taking part in another clinical trial of an investigational medicinal product;
* Life expectancy less than 1 year due to Severe medical disease;
* other reasons that are unsuitable for the trial in the investigator's opinion.
CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT

Background:

Social Anxiety Disorder (SAD) is a common mental problem, where people experience severe and disabling anxiety about social situations and interactions. It is highly prevalent world-wide and in Hong Kong, causing significant suffering/distress. While evidence-based interventions exist, e.g., cognitive behavioural therapy (CBT), there will be not enough trained therapists to meet the treatment demand so that the majority of the SAD patients receive no treatment. Internet-based therapies may offer a solution, given that they deliver treatment more cost-efficiently by requiring lesser therapist time so that more patients can be treated with the same therapist resources. One UK internet-based CBT protocol for SAD, iCBT(C\&W), shows high efficacy and efficiency in initial UK and Hong Kong trials with Englishspeaking patients.

Objectives:

1. To develop and confirm the efficacy of a Chinese-language version of iCBT(C\&W), administered by clinical psychologists in standard therapist-guided format.
2. To develop an even more cost-efficient new self-help format with some minimal 'coaching' performed by trained psychology bachelor-level graduates - its efficacy expected as 'noninferior' to that of the therapist-guided format.

Overall design:

Three-arm parallel group randomised controlled noninferiority trial: Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD vs. Waitlist

Method:

The iCBT(C\&W) protocol will be translated into Chinese. Approximately 110 Chinese adults with SAD will be recruited in Hong Kong and randomised into one of two treatment conditions, therapist-guided versus self-help. The treatment lasts 14 weeks. The primary outcome measure will be Liebowitz Social Anxiety Scale (self-report version).


Eligibility Criteria:
Inclusion

* Meets DSM-5 criteria for SAD (SAD must be generalised, not the 'performance only' subtype)
* Considers SAD their main problem
* Age 18 or over (no upper age limit)
* No current psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dose throughout trial
* Participant agrees not to start any other forms of treatment during the trial
* Chinese resident of Hong Kong
* Proficient in written traditional Chinese and spoken Cantonese
* Internet access from home

Exclusion

* current or past psychosis, bipolar disorder, or borderline personality disorder
* active suicidality
* 'Moderate' or 'Severe' Alcohol Use Disorder or Substance Use Disorder (based on DSM-5)
* No current or previous CBT for SAD (defined as at least 5 sessions, and including an exposure component), including internet-CBT studies
* Not another current emotional problem that is the participant's main concern (Participant must not be largely absorbed in another emotional problem, for which it would be unethical not to address as a priority)
A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003

This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.


Eligibility Criteria:
Major Inclusion Criteria:

* Provision of written informed consent prior to any study-specific procedure;
* Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
* Satisfies one of the following:

  1. Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR
  2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose;

Major Exclusion Criteria:

* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF \>450;
* Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer;
tDCS and Speech Therapy to Improve Aphasia

To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients will be randomized by a computer-generated lot. Assessment will be performed at study onset, after six weeks at the end of the specific intervention and 4 months after stroke onset for follow-up.

Approximately 25% of all patients after stroke suffer from aphasia. The aphasia could be so severe, that the patient cannot produce any words at all, and so the communication ability is rather poor. In that case speech therapy is the most common therapy, but the functional outcome for the patient is often not sufficiently. The transcranial direct current stimulation (tDCS) might improve the outcome of speech therapy in patients with severe aphasia. The patients will be randomized either to verum stimulation (group A) or sham stimulation (group B). In group A they will receive every workday for 6 weeks 20min of tDCS with 2 mA in combination with a 30 min speech therapy. In group B they will receive every workday for 6 weeks 20min of tDCS with 0 mA in combination with a 30 min speech therapy. The anodal electrode will be placed in case of a total anterior circulation stroke on the homologous speech area on the right hemisphere and in case of a partial anterior circulation stroke perilesional on the left hemisphere. The cathode will be positioned contralateral.

Eligibility Criteria:
Inclusion Criteria:

* first time stroke (ischemic or hemorrhagic), either with a total or partial anterior circulation stroke according to the Bamford classification
* stroke interval 10-45 days
* moderate or severe aphasia, i.e. Goodglass-Kaplan-Communication-Scale (GKS, 0,1 or 2)
* native speaker - german
* age 18-90

Exclusion Criteria:

* other neurological diseases affecting the CNS
* known history of epileptic fits, except for an immediate fit
* signs in the EEG of increased cortical excitability
* patients with hemicraniectomy
* fluent aphasia, i.e. GKS 3,4 or 5
* speech apraxia
* reduced sensibility of the scalp
* previously radiated scalp
* metallic parts or implants in the brain
* participation in other interventional studies
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer

The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.

Another objective of the trial is to assess and compare the safety of each treatment.

Further study details as provided by Centre Oscar Lambret.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic colo-rectal cancer
* Age \> or = 18 years old
* PS-WHO \< or = 2
* Polynuclear neutrophil leukocytes \> or = 1500/mm3, platelets \> or = 100000/mm3
* Total bilirubin \< or = 3 ULN, ASAT-ALAT \< or = 2.5 ULN
* Effective contraception
* Written informed consent signed

Exclusion Criteria:

* Concomitant radiotherapy
* Contraindication to fluoropyrimidines
* Treatment with sorivudine and its chemical analogs such as brivudine
* Severe hepatic insufficiency
* Severe renal insufficiency
* Pregnant or lactating woman
* Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
Effectiveness of Auricular Point Acupressure in Improving Quality of Life in Patients With Pancreatic Cancer

This study will investigate the effectiveness of auricular point acupressure in improving fatigue,sleep quality,physical activity and quality of life in patients with pancreatic cancer under chemotherapy in taiwan.

Hypothesis:

1. The fatigue in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
2. The sleep quality in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
3. The physical activity in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
4. The quality of life in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.

This study will investigate the effectiveness of auricular point acupressure in improving fatigue,sleep quality,physical activity and quality of life in patients with pancreatic cancer under chemotherapy in taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese, and is able to perform ear acupoints by himself/herself.
2. Pancreatic Cancer patients who received chemotherapy in inpatient and outpatient department.
3. The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

Exclusion Criteria:

1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.
2. Patient who is not suitable for ear acupoint pressing after evaluated by the attending physician.
Screening for Fabry Disease in a Pediatric Population at Risk

The purpose of this study is to assess the frequency of Fabry disease in children with chronic abdominal pain or chronic pain in the extremities


Eligibility Criteria:
Inclusion Criteria:

* Age below 18 years
* One of the following criteria:

  * Diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months
  * Chronic, recurrent abdominal pain for more than 6 months
* Planned blood sample for routine diagnostics
* Written informed consent

Exclusion Criteria:

- Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.
Vestibular Dysfunction In Adult Patients With Panic Disorder With or Without Agoraphobia

OBJECTIVES: I. Determine whether the prevalence of abnormalities on clinical vestibular (balance) tests is higher in panic disorder with agoraphobia than in uncomplicated panic disorder and nonpanic anxiety disorder.

II. Determine whether the prevalence of abnormalities on audiological tests of cochlear or brainstem function is elevated in panic disorder without agoraphobia or nonpanic anxiety disorder.

III. Determine whether symptom patterns can be identified that are indicative of vestibular abnormalities in panic disorder.

IV. Determine whether vestibular dysfunction can be induced by psychosomatic mechanisms.

PROTOCOL OUTLINE: Patients are stratified by otoneurological function (panic disorder without agoraphobia, panic disorder with agoraphobia, anxiety disorder without panic or agoraphobia-like avoidance, and normal controls).

Patients undergo a psychiatric interview and a structured interview focused on anxiety disorders. Physical evaluation is completed.

A vestibular evaluation consisting of posturography, rotational testing, and ocular motor screening battery, and positional and caloric testing is completed on all patients. Patients then complete an audiological test battery consisting of basic audiological analysis, speech recognition scores, immittance testing, brainstem evoked response, and determination of binaural masking level differences.

Control patients also complete a hyperventilation-rotational test.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnostically proven panic disorders with or without moderate or severe agoraphobia and anxiety disorders without panic or agoraphobia Panic disorder may be accompanied by a secondary Axis 1 diagnosis of another disorder, such as depression, generalized anxiety disorder, or dependent, histrionic, or compulsive personality disorder --Prior/Concurrent Therapy-- Surgery: No prior ear surgery Other: No concurrent medication for medical or psychiatric conditions At least 2 weeks since prior medication No ototoxic drug intake --Patient Characteristics-- No medical disorders At least 2 weeks since prior upper respiratory tract infection and recovered No history of migraine No head trauma No scoliosis No alcoholism No drug abuse No family history of schizophrenia
Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax

Study Objective: To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the development and clinical application of bronchial occlusion.

Study Population: Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax.

Sample Size: This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax. The sample size has not been strictly calculated, and it is expected to include 10 patients.

Study Design: This study is an exploratory, single-group, single-center clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled:

  1. Male or female, aged ≥18 years;
  2. Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days;
  3. After evaluation by the researcher, the subject is feasible for the bronchoscopic procedure of selective bronchial occlusion to treat refractory pneumothorax, and the responsible bronchus can be determined by the balloon detection;
  4. Voluntarily participate in this trial and sign an informed consent form.

Exclusion Criteria:

* Subjects with any of the following conditions cannot be selected:

  1. Allergic to silicone materials;
  2. Contraindications for bronchoscopy:

     * Myocardial infarction within the past month;
     * Active massive hemoptysis;
     * Platelet count \<20×10\^9/L;
     * Pregnancy;
     * Malignant arrhythmias, unstable angina, severe cardiopulmonary dysfunction, hypertensive crisis, severe pulmonary arterial hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness, and extreme systemic exhaustion, etc.
  3. Uncontrolled acute pulmonary infection or severe chronic infection at the intended occlusion lobes or segments;
  4. Obvious hemodynamic instability or unstable respiratory failure;
  5. The responsible bronchus cannot be determined by balloon detection;
  6. The researcher believes that the patient has other conditions that are not suitable for inclusion in this study.
The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse

For the purpose of this pilot study, the investigators hypothesize that the use of the Step Up Your Game protocol will result in statistically significant improvements in health and athletic performance. The key to this is the coordination of resources from a supervising physician, physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would allow patients to find or be their own physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. The role of the supervising physician, however, is meant for a qualified professional, who follows the osteopathic approach to medicine, in which the body is treated as an integrated whole, while also working to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is critical to take into account every health aim and injury in the context of the athlete and how these affect all aspects of participants lives.


Eligibility Criteria:
Inclusion Criteria:

* Individuals capable of giving consent between ages of 18 and 22.
* Must be members of the NYIT lacrosse team.

Exclusion Criteria:

* Individuals who are not able to participate throughout the season whether it's due to a medical problem or academic probation.
* Individuals who are receiving sports related medical care other than that from the physician in study.
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Eligibility Criteria:
* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

- None