cyrilzakka/clinical-trials huggingface dataset:
A Study of Pulmonary Hypertension Peripheral Limitations

The investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with Pulmonary Arterial Hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary Arterial Hypertension (PAH) Subjects:

   1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
   2. NYHA Class II-IV
   3. LVEF ≥ 40 % within the preceding year.
   4. No hospitalizations due to heart failure in the preceding 30 days.
   5. No recent initiation of pulmonary vasodilator in the last 60 days
   6. Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg).
   7. Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms
2. Healthy Controls:

   1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
   2. No known diagnosis of heart failure

Exclusion Criteria:

* Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
* Planned coronary, carotid, or peripheral artery revascularization.
* Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
* Wheelchair bound or orthopedic inability to exercise
* Chronic hypoxemia with inability to exercise without oxygen supplementation (PAH Subjects) or need for oxygen supplementation (Healthy Controls)
* Skeletal muscle myopathy
* History of rhabdomyolysis
* Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
* Receipt of any investigational medicinal product within 30 days before screening
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
* Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer

This study aims to 1) implement a culturally and contextually rooted innovative multifoci, social marketing intervention involving societal focused media campaign elements to break down the barriers and facilitate timely and appropriate screening practices for cervical cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP test. Further, this is an international study that will bring together a multi-disciplinary investigatory team, community advocates and State health agencies to deliver a social marketing intervention in Southern California (the Inland Empire region specifically) and Trinidad and Tobago.


Eligibility Criteria:
Inclusion Criteria:

Women will be included if they:

1. have not been diagnosed with any type of cancer
2. are between the ages of 18-70
3. self-identify as being African descended or Latina
4. are able to speak English and/or Spanish
5. acknowledge that a Pap test is currently needed

Exclusion Criteria:

1. Cervical cancer is diagnosed only in women, therefore this study only includes women
2. Women who have been and/or are currently diagnosed with any type of cancer will be excluded
3. Women with other major medical conditions (e.g. stroke and degenerative illness) will be excluded
4. During the screening the level of symptomatology for depression and anxiety will be assessed. Women with severe depression and anxiety will be excluded, but appropriate psychological follow-up and referral will be provided
5. Women older than 70 years will be excluded
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Eligibility Criteria:
Inclusion Criteria:

* Patient has diagnosis of Diabetes Mellitus, Type I or II.
* Patient has experienced the development of macular edema following cataract surgery in at least one eye.
* Patient has had cataract surgery within 90 days prior to the screening visit.

Exclusion Criteria:

* Patient has other significant ocular disease in study eye, including glaucoma.
* Patient has any active infection in the study eye.
* Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
* Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
* Patient has received the OZURDEX® implant before in the study eye.
Effect of Short-term Motor Training on Accuracy and Precision of Knee Movement in Human With and Without Knee Pain

The objects of this research are to investigate the ability of the motor learning and test the possible differences between younger and older healthy human, and between non-pain and acute experimental pain and chronic clinical pain conditions.

The project consists of four experimental studies. In the first experiment, younger and older healthy human subjects are involved in a short-term neuromuscular training on the accuracy and precision of knee movement to investigate the possible age effect of the motor learning. The second experiment focuses on the experimental pain on the learning effect of the younger subjects. The third experiment will investigate a group of knee osteoarthritis patients to show the influence of chronic pain on the motor training compared with age-, gender-matched pain free subjects. 3D camera tracking system will be used to record the knee movements at the baseline and after 6-day motor task training. The variability in amplitude of the values of knee movements was transformed to percentage in relation to the target position (accuracy) or to the mean position (precision). The results of the study will contribute to both basic and clinical understanding of the mechanisms related to knee movement control and influences of varies painful conditions.

Eligibility Criteria:
Inclusion Criteria:

* • Aged 18-30 or 50-65 years

  * Free from ongoing or chronic pain
  * Right dominant leg
  * Speak and understand English
  * Aged 50-65 years.
  * Diagnosed with knee OA (according to American College of Rheumatology classification) with pain in left or both knees for more than six months
  * Have ongoing pain rated above 2 on a 0-10 Visual Analogues Scale (VAS) in the previous week.
  * Right dominant leg
  * Speak and understand English
  * Aged 50-65 years
  * Diagnosed with knee OA
  * Have had total knee arthroplasty on left or both knees
  * Right dominant leg
  * Speak and understand English

Exclusion Criteria:

* • Pregnancy or intent to become pregnant, breast feeding

  * Regular use of analgesics, including simple analgesia and NSAIDs
  * Frequent recreational drug or alcohol use
  * History of knee joint pathology or injury
  * Previous neurologic, musculoskeletal or mental illnesses
  * Practicing sport activities on a regular basis
  * Lack of ability to cooperate
  * Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours
  * Frequent recreational drug or alcohol use
  * Previous neurologic, musculoskeletal or mental illnesses
  * Practicing sports activities on a regular basis
  * Lack of ability to cooperate
  * Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours
  * Frequent recreational drug or alcohol use
  * Other disorders or injuries in the knee joints
  * Previous neurologic, musculoskeletal or mental illnesses
  * Practicing sports activities on a regular basis
  * Lack of ability to cooperate
Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study

Cisplatin-combination chemotherapy causes inevitably DNA damage by platinum-DNA adduct formation of both tumor cells but also healthy cells. It therefore stands to reason that testicular cancer treatment causes an increased burden of senescent cells, which causes upregulation of the SASP resulting in a pro-inflammatory phenotype. The investigators hypothesize that this may be an important mechanism behind development of late effects and an early ageing phenotype after treatment for testicular cancer.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the cross-sectional part of this study, a subject must meet all of the following criteria:

* Diagnosed with metastatic testicular cancer in 1999-2012 (stage II or higher)
* Received first-line cisplatin-based chemotherapy
* Was younger than 50 years of age at start of chemotherapy

In order to be eligible to participate in the longitudinal part of this study, a subject must meet all of the following criteria:

Chemotherapy-group:

* Diagnosis of metastatic testicular cancer (stage II or higher)
* Is about to start with first-line cisplatin-based chemotherapy
* Younger than 50 years of age at diagnosis of metastatic testicular cancer

Stage I control-group:

* Diagnosis of testicular cancer stage I disease
* Younger than 50 years of age at diagnosis of testicular cancer

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

- Not able to provide informed consent (in example in case of mental or psychiatric disability)
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.

If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.

Eligibility Criteria:
Inclusion Criteria:

1. at least 6 weeks after stroke diagnosis
2. upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score \> 2
3. ability to stand and walk safely without help or assistance

Exclusion Criteria:

1. improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
2. previous contracture and/or deformity of the upper extremities
3. concurrent peripheral neuropathy and/or myopathy
4. difficulty in participating in the study due to cognitive impairment.
Increasing School Meal Participation

This study aims to determine whether an online marketing campaign increases children's school meal participation. Parents whose children do not currently eat school meals frequently will be exposed to messages designed to encourage their children's increased participation in school meals.

In this 6-week-long online randomized controlled trial, participants will be randomized to one of two arms: 1) Control (neutral) messages or 2) Messages designed to increase school meal participation. In each arm, participants will join private Facebook groups corresponding to their study arm. The study team will post campaign messages to these groups. Participants will answer online survey questions before and after the study on their attitudes about school meals and their child's participation in school meals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Parent of a child attending a public school in grades 1-5
* Resides in one of the following states: California, Colorado, Maine, Minnesota, Michigan, Massachusetts, New Mexico, Vermont
* Has internet access
* Has a Facebook account
* Child consumes 3 or fewer school lunches per week or 3 or fewer school breakfasts per week

Exclusion Criteria:

* Younger than 18 years old
* Does not have a child attending a public school in grades 1-5
* Resides out of one of the following states: California, Colorado, Maine, Minnesota, Michigan, Massachusetts, New Mexico, Vermont
* Does not have internet access
* Does not have a Facebook account
* Child consumes more than 3 school lunches per week and more than 3 school breakfasts per week
Renal Denervation for Complicated Hypertension

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

* intolerance to antihypertensive medication
* inability to take antihypertensive medication due to planned pregnancy
* renal artery stenosis
* chronic kidney disease
* non-compliance to antihypertensive medication

A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.

The duration of this study is 36 months.


Eligibility Criteria:
Inclusion Criteria:

* BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
* Intolerance to ≥2 antihypertensive drug classes
* Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
* Renal artery stenosis
* Chronic Kidney Disease

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of childbearing potential must have negative pregnancy test prior to treatment
OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals

Undernutrition is the result of energy and protein deficiency and / or catabolic. These phenomena are observed daily in patients awaiting lung transplantation.

After lung transplantation that undernutrition is growing (on average 11% weight loss after the first observations in the continuing care of the University Hospital of Strasbourg). In other words the non-malnourished patients become. Hence the importance to reach every patient awaiting transplant, mainly to patients already malnourished before surgery.

Several studies have shown that early nutritional support has a direct effect on reducing comorbidities and the average length of stay. In the course of care of these patients it is necessary to intensify the dietary management to give them the best chance for early rehabilitation.

The main objective of the study is to evaluate the impact of the use of the SFNEP's nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme) on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung transplantation.


Eligibility Criteria:
Inclusion criteria:

transplant patients between January 1, 2012 and December 31, 2015 aged over 16 years, with a BMI \<25 at the time of pre-transplant assessment and that not oppose the use of his data.

Exclusion criteria:

* Cardiopulmonary Transplant Patients
* refusal to participate in the study
A Clinical Trial on the Antipsychotic Properties of Cannabidiol

The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.

Despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. The endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures.

The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Diagnosis of schizophrenic or schizophreniform psychosis
* Minimal initial score of 36 in the BPRS total score and a minimum of 12 in the BPRS Psychosis Cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content)
* Exclusion of pregnancy in female subjects through negative β-HCG test

Exclusion Criteria:

* Lack of accountability
* Pregnancy or risk of pregnancy or lactation.
* Other relevant interferences of axis 1 according to diagnostic evaluation through MINI including undifferentiated residual forms of schizophrenia.
* Treatment with depot-antipsychotics during the last three months.
* Severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. Positive Hepatitis-serology.
* QTc-elongation.
* Acute suicidal tendency of or hazard to others by the patient
Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis

This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition, this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).

The present study will be a randomized, double-blind, crossover trial. Each nebulized solution \[hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%)\] will be administrated during 4 days. After each inhalation, all patients will carry out a bronchial drainage session (autogenic drainage technique). All patients recruited will perform the three arms of intervention. In this way, each patient will be able to act as his/her own control.

A 7 days washout period will be required among the different solutions to avoid carryover effects.

During the study period the patients' pharmacological treatment remained unchanged.

Eligibility Criteria:
Inclusion Criteria:

1. Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
2. Mean sputum production ≥ 10 ml /24h.
3. Clinical stability in the last 4 weeks
4. To be able to understand how to perform inhalation and the physiotherapy session.
5. To be able to provide written, informed consent

Exclusion Criteria:

1. Forced expiratory volume in 1 second \< 30% pred. ; Total lung capacity \< 45% pred.
2. Performing nebulization with any hyperosmolar agents, previously
3. Allergic bronchopulmonary aspergillosis diagnosis
4. Not to be able to overcome the safety test pre-intervention (oxygen saturation levels drop to \< 90% and/or forced expiratory volume in 1 second decline more than \< 12% from baseline during the nebulization process)
Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis

Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

neonatal early onset spesis (EOS) remains animportant etiology of neonatal morbidity and mortality. Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. Diagnosis is difficults due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS.The objective of the study was to identify early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in the gastric suction culture.The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

Eligibility Criteria:
Inclusion Criteria:

* Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs

Exclusion Criteria:

* Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology
Patient Convenience Study

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).


Eligibility Criteria:
Inclusion criteria:

Cohort A:

1. A. Written informed consent prior to participation
2. A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

1. B. Written informed consent prior to participation.
2. B. Female and male patients \>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
3. Current participation in any clinical trial of a drug or device.
4. Current participation in an European registry on the use of oral anticoagulation in AF.