cyrilzakka/clinical-trials huggingface dataset:
Intracardiac T-wave Alternans and Ischemia

T-wave alternans is a test that looks at microvolt changes in the T-wave on a beat to beat basis. The presence or absence of such changes has been shown to predict or exclude future arrhythmic events. The mechanism of T-wave alternans is unclear, but may relate to calcium metabolism in the heart, and may be affected by conditions such as ischemia or heart failure.

The purpose of this study is to determine whether T-wave alternans, as measured through the lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion during percutaneous coronary interventions.


Eligibility Criteria:
Inclusion Criteria:

* patient with CAD undergoing PCI with appropriate Medtronic implantable defibrillator.

Exclusion Criteria:

* non-elective procedure
* non-qualifying defibrillator type.
Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory

Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.

To evaluate treatment adherence and blood pressure reduction, through the HiperCross App, between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto Alegre.

The investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the HiperCross application.

Eligibility Criteria:
Inclusion Criteria:

* hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia
* older 18 years

Exclusion Criteria:

* Patients without a mobile phone compatible with the App
An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of migraine with onset at ≤50 years of age.
* Body weight ≥45 kilograms.
* The participant has a history of migraine for ≥12 months prior to screening.
* Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)
* Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically \[that is; vasectomy\] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).

  * Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
* Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
* The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
* The participant uses triptans/ergots as preventive therapies for migraine.
* Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.

  * Additional criteria apply, please contact the investigator for more information.
Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment

The purpose of the study is to determent whether there is a difference between two types of treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in terms of their sensation of how they have been helped and their treatments' outcomes measures. The study hypothesizes are: a) Based on the results of literature review which does not reveal a clear difference between group and individual treatments' outcomes for LBP, it is hypothesized that no difference will be found in treatment results for the two types of group treatments in the present study also, b) The assumption is that different distribution of therapeutic factors will be found in the two types of treatments (individual, group), C) Patients' sensation of how they have been helped will be connected to treatment results.

200 patients with LBP looking for physiotherapy treatment in 15 clinics at Maccabi Healthcare Service in Israel will be recruited. (100 after competion individual therapy, 100 after competion of group therapy). As part of the regular routine in these clinics, patients will be asked to fill the LFSQ, a questionnaire which deals with their back functional status, their level of pain and fear avoidance of physical activity before and after treatment. In the present study, patients will be asked to fill the LFSQ again, 6 months after treatment completion. In two weeks from treatment completion, patients will be interviewed on the telephone. The interview will focuse on their sensation of how they have been helped. It will include an open-ended question and 18 closed questions.

The main study variables will include: participants' perception of functional status, level pain, level of fear avoidance of physical activity, patient-therapist bonding, and helpful therapeutic impacts (client's sense of how she or he has been helped).

Eligibility Criteria:
Inclusion Criteria:

* Low back pain,
* 18 years old and older
* Hebrew speakers , who filled the LFSQ (Lumbar Functional Status Questionnaire) at first visit
* Agreed to participate in this study

Exclusion Criteria:

* Pregnant
* After back or hip operation in the last year
* Back problem from non- orthopedic origin
Effectiveness of a Pain Management Programme

Persistent pain (PP) affects many people worldwide. Patient Education is central to good management. Pain neurophysiology education (PNE) is a new form of education. It aims to help patients 'reconceptualise' their understanding of pain away from the perception that PP is an indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is considered a less threatening and more conducive to rehabilitation. There is a growing body of evidence supporting its effectiveness. One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects. However, there is a need to test this intervention rigorously under randomised controlled trial conditions to inform clinical practice. The Medical Research Council state that during the development and evaluation of a complex intervention (in this case a PNE informed PMP), it is important to undertake feasibility work, to investigate the components of randomised controlled trial (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods study is to develop a feasible research protocol for a RCT investigating the efficacy of a pain neurophysiology education informed pain management programme. In this feasibility study, participants with PP will be assessed before and after a PNE informed pain management program that they are due to receive as part of their usual care. In the week before the programme participants will attend Teesside University (TU) where they will complete a battery of outcome measures. A subsample of participants will also undergo a semi-structured interview. In the week following completion of their usual care PMP participants will once again attend TU where they will complete the same outcome measures and the same subsample of participants will undergo a second semi-structured interview. At this point participants will have completed the study.


Eligibility Criteria:
Inclusion Criteria:

* Have capacity to give informed consent
* 18+ years of age
* Have had pain that has persisted for greater than six months
* Have been referred to the pain management programme at James Cook University Hospital.

Exclusion Criteria:

* Pain arising from a non-musculoskeletal origin such as cancer pain, visceral pain or post stroke pain
* Have worsening neural signs
* Anyone being treated by or who has been treated by the researcher (JW)
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must give a written, signed and dated informed consent
* Chronic plaque-type psoriasis present for at least 6 months before randomization
* Moderate to severe plaque psoriasis as defined at randomization by:

  * PASI score of ≥12 and
  * Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
  * IGA mod 2011 ≥3 (based on a scale of 0-4)
* Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:

  * Topical treatment (including topical corticosteroids) and/or
  * Phototherapy and/or
  * Previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than plaque psoriasis
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
* Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Pelvic Floor-Based Training on Dysmenorrhea

The aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. The main question it aims to answer is the questions are as follows:

1. Is patient education effective in improving symptoms in young women with primary dysmenorrhea?
2. Is there a relationship between knowledge level and symptoms in young women with primary dysmenorrhea?

Participants will:

After the training group was given the training in 2 sessions, the participants were asked to apply the exercises in which the training was given. The control group applied conventional self-methods when dysmenorrhea symptoms occurred. The evaluations were made before the training and at the end of the first menstrual cycle.

Dysmenorrhea is pain that occurs during menstruation due to cramps in the uterus. It is one of the most common causes of pelvic pain, especially experienced by young women. primary dysmenorrhea is distinguished from secondary dysmenorrhea by the occurrence of pain in women with normal pelvic anatomy without any pathology or physiological etiology. In the management of primary dysmenorrhea, non-pharmacological treatment methods such as lifestyle changes, sleep and nutrition changes, exercise, and physiotherapy applications are used in addition to pharmacological treatments. The aim of this study is to examine the effect of patient education on the pelvic floor knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. In this study, participants were divided into two groups: the education group and the control group. The evaluations were made before the education and after the first menstrual cycle. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with primary dysmenorrhea
* Being between the ages of 18-35
* Having a regular menstrual cycle
* Volunteering to participate in the study

Exclusion Criteria:

* Not having a history of endometriosis or gynecological pathology •
* Having a history of gynecological disease or surgery
* Having a neurological or musculoskeletal problem
Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome

Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined.

The study included 72 patients with CTS aged 18-65 years who applied to Kırşehir Ahi Evran University Training and Research Hospital Physical Therapy and Rehabilitation Center.

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. In CTS, the median nerve is compressed within the carpal canal, about 1 to 2 cm beyond the distal wrist crease. It is more common in women and is typically more severe in the dominant hand but is often bilateral. Repetitive hand and wrist movements, such as using a keyboard or vibrating tools, have been associated with CTS. Medical conditions associated with CTS include diabetes, hypothyroidism and RA, as well as obesity and pregnancy. Rarely, CTS may be caused by a mass lesion in the wrist, such as a ganglion cyst or neurofibroma, or may be associated with acute trauma to the wrist. The vast majority of CTS cases are idiopathic.

CTS treatment is divided into conservative and surgical treatment. Conservative treatment methods are recommended in mild and moderate CTS patients, while surgical treatment is recommended in severe cases.

Extracorporeal Shock Wave Therapy is one of the physical therapy applications used in the treatment of Carpal Tunnel. The effectiveness of ESWT in the treatment of CTS will be examined

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65 years with carpal tunnel syndrome diagnosed clinically and by EMG
* Patients who can correctly understand what is stated in the patient information form and who can cooperate
* Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria:

* Cervical radiculopathy
* Polyneuropathy
* Brachial plexopathy
* Use of systemic corticosteroids or local corticosteroid injections
* History of fracture and trauma in the forearm and wrist on the treated side
* Inflammatory rheumatic disease
* Pregnant and lactating patients
* Systemic diseases such as renal failure, peptic ulcer, DM, hypothyroidism, coagulation disorder
* Patients undergoing carpal tunnel syndrome surgery
* People with pacemakers
* Thoracic outlet syndrome
* Tenar atrophy, severe carpal tunnel syndrome
Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair

The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.

This study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a PREVENA incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will include perceived difference in Quality of Life and cost-effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
2. have one or more of the following risk factors for post-operative surgical site complications:

   1. Body Mass Index (BMI) greater than or equal to 30
   2. diagnosis of diabetes mellitus (either type I or II)
   3. previous history of hernia recurrence
   4. active smoker
   5. presence of colostomy or ileostomy
   6. age greater than 64
   7. chronic obstructive pulmonary disease
   8. chronic kidney disease
   9. clinically immunocompromised.

Exclusion Criteria:

1. the abdomen is left open post-operatively, or
2. if the patient has a sensitivity to silver.
The Effect of Processed Tomato Products on CVD Risks

The primary working hypothesis is that consuming processed tomatoes frequently/daily will favorably improve endothelium and platelet function disease-risk biomarker profiles in adult men and women compared to consuming no or relatively low amounts of processed tomatoes.


Eligibility Criteria:
Inclusion Criteria:

men and women (\>21 \<70 years) nonsmokers, with a body mass index (BMI) ranging of 25 to 35 kg/m2, BP \< or = 140/90 mmHg

Exclusion Criteria:

1. Total cholesterol (TC) is greater than 300 mg/dL;
2. Fasting triglyceride is greater than 300 mg/dL;
3. LDL cholesterol (LDL-C) is greater than 180 mg/dL;
4. Female subjects who are pregnant or lactating;
5. Subjects who are actively losing weight or trying to lose weight;
6. Subjects with known allergy or intolerance to tomato products;
7. taking any medications that would interfere with outcomes of the study, ie. lipid lowering medications, anti-inflammatory drugs, dietary supplements, such as fish oil or evening primrose;
8. subjects' with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (\>=140/90 mm Hg - ok if controlled below this limit with medication), or other systemic diseases;
9. subjects with low hematological counts as determined by \>or \<15% the upper or lower cut-off values of normal established for the lab;
10. Smokers. -
Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery

This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70

Exclusion Criteria:

* Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.
Contact to a Physician Specialized in Social Medicine and Return to Work

The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.

In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and risk of low work ability - based on questionnaires participated in a randomized control trial. The patients were randomized to either the intervention group (n=220) or control group (n=223). The intervention group were invited to the Department of Social Medicine two to four weeks after their first contact to Department of Rheumatology for a consultation with a physician specialized in social medicine. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. Throughout the intervention, the patients received their usual treatment from the Department of Rheumatology like patients from the control group. Outcome was return to the work force at one year follow up using information from a national registry.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 and \< 60 years old,
* not receiving disability pension and not on maternity leave.
* sick leave over the past year for more than ten days
* low self-rated work ability for the next two years
* health anxiety

Exclusion Criteria:

-
Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)
* Patients receiving radiotherapy dose \> 40 Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria