cyrilzakka/clinical-trials huggingface dataset:
Effect of Proprioceptive Neuromuscular Facilitation on Blood Pressure

To determine the effect of Proprioceptive Neuromuscular Facilitation exercise on blood pressure in patient with mild to moderate hypertension.Both genders will be included.Patients aged between 40 and 60 years with mild and moderate hypertension.Systolic blood pressure 130-160 mmHg or Diastolic Blood Pressure 80-100 mmHg.

Sphygmomanometer and EuroQoL five-dimensional instrument would be used for the 'Pre' \& 'Post' assessment.

There is a belief that proprioceptive neuromuscular facilitation exercises cause cardiac overload as blood pressure in immediately influenced by exercise but Pereira concluded in his research that proprioceptive neuromuscular facilitation exercises with minimum repetitions are safe for hypertensive or cardiovascular patients because in his study there is no increase in blood pressure in older women after performing three different types of PNF exercises. Pereira discovered that rhythmic initiation , dynamic reversals , and combination of isotonic techniques did not raise blood pressure levels, thus it is recommended to use up to five repeats of repetition maximum . One study observed at the effects of passive and modified proprioceptive neuromuscular facilitation (PNF)stretching techniques on acute systolic and diastolic blood pressure responses. All PNF treatments were beneficial in increasing Range of motion, as we all know.

PNF improves Range Of Motion while avoiding an increase in Systolic blood pressure in one or two trials, but increases Systolic blood pressure in a third trial. Blood pressure rises by 40% with conventional exercise programmers and because PNF involves near-maximal resistance,researchers anticipated a considerable rise in blood pressure during PNF execution. It was discovered that elderly subjects could not readily execute more than five to seven repetitions of PNF exercises, which has also been shown by others. Due to the low repetition number of each movement pattern, the results showed that PNF did not induce a high enough workload to increase blood pressure in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Both genders will be included.
* Patients aged between 40 and 60 years with mild and moderate hypertension.
* Systolic blood pressure 130-160 mmHg or Diastolic blood pressure 80-100 mmHg.
* Mild and moderate hypertension with diabetes

Exclusion Criteria:

* Severe hypertensive patients.
* Patient on smoking
* Patient with severe complications and comorbidities.
* Not willing to give consent/ data
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery

Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a DJ stent for passive dilatation and subsequent RIRC

Exclusion Criteria:

* Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor
Zydena on Cognitive Function of Alzheimer's Disease Patients

The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on cognitive function in patients with Alzheimer's disease.

This study is a randomized, double blind, placebo-controlled multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent;
* Male or female subjects 50 to 90 years of age;
* Diagnosis of probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria;
* A Mini-Mental State Examination (MMSE) score of ≥10 and ≤26;
* Global Clinical Dementia Rating ≥ 0.5;
* Mild to moderate (not severe) white matter hyperintensities on brain MRI performed within three years from screening;
* Good enough hearing and visual function to complete neuropsychological tests
* Caregivers living with patients or spending 10 or more hours a week with patients;
* Stable dose of donepezil (5mg to 10mg) for at least 60 days;
* If patients have been on memantine, it should be washed out for at least 60 days;
* Medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks

Exclusion Criteria:

* History of stroke within 6 months;
* Previous diagnosis of severe (more than 80%) intracranial artery stenosis;
* History of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia;
* Previous history of coronary artery bypass graft surgery;
* Severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (Alfuzosin, Doxazosin, Naftopidil, Tamsulosin, Terazosin, Arotinolol, Carvedilol, Labetalol, Trazodone, typical and atypical antipsychotics);
* Uncontrolled diabetes mellitus;
* Proliferative diabetic retinopathy;
* Severe hypotension (blood pressure less than 90/50mmHg) or severe hypertension (blood pressure more than 170/100mmHg);
* Hepatic dysfunction (AST or ALT more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dL);
* Retinitis pigmentosa;
* Previous history of active peptic ulceration within one year before screening;
* Hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders;
* History of drug abuse;
* Medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and Sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants;
* Current cancer chemotherapy;
* Usage of PDE5i (Zydena, Viagra®, Levitra®, or Cialis®) within two weeks before study start;
* History of hypersensitive reaction to PDE5i (Zydena, Viagra®, Levitra®, or Cialis®)
Phototoxicity Potential of NatrOVA Creme Rinse - 1%

This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18-65 years of age and in good health.
2. Fitzpatrick skin type I, II or III

Exclusion Criteria:

1. History of severe reactions from exposure to sunlight
2. Known allergies or sensitivities to adhesives in patches
3. Inability to evaluate the skin in and around the test sites
4. Diabetes requiring medication
5. Clinical significant skin disease
6. Asthma or other severe respiratory disease
7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
8. History or current skin cancer
9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
10. Epilepsy
11. Pregnancy, lactation, or planned pregnancy during study period
12. Chronic use of systemic antihistamine medication within 14 days of screening
13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
14. Currently receiving allergy injections
15. Use of immunosuppressive drugs
16. Topical drugs used at the test site within 7 days of Screening Visit 1
17. Current participation in any clinical trial
18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
19. Use of any investigational drug therapy within 4 weeks of study start.
Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients

Technological developments in the recent decades has enabled the integration of electronic and digital components in the stethoscope design, in an attempt to improve auditory performance and, moreover, to assist in improving user's diagnostic accuracy by incorporating computerized, digital technologies, artificial intelligence capabilities and deep-learning-based algorithms enhancing these devices.

We believe that these technologies can be used to significantly improve the diagnostic performance in the primary care phase, by means of a sophisticated stethoscope that enables auscultation to sounds and signals typically found in the sub-sound frequency level. Their transformation into the sound range, and the use of artificial intelligence and machine learning techniques to characterize sound patterns that correspond to specific problems or diseases can substantially enhance the physician's or other care giver's performance to the benefit of the patients.

At this stage, the software in development does not purport to make diagnostic decisions, but only to provide information that will enhance decision and diagnosis making process, therefore enable a more accurate and definitive diagnostic decision and perhaps decrease the number of additional diagnostic tests requested.

Up to 200 patients will participate in an open, prospective and multi-center study.

Patients diagnosed as positive to COVID-19 will be referred to a VOQX examination. All patients will receive detailed explanation about the purpose of the examination, its impact and will provide their consent prior to the examination. The VOQX device output will have no influence on the decision-making process of the physicians and care givers. The VOQX Stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. The data collected in the form of breath sound signals in particular infra-sound will be transferred to an external computer and processed by machine learning algorithm developed by the company. The algorithm will seek patterns typical for the diagnosed disease for each corresponding case diagnosed.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years
* RT-PCR positive for COVID 19
* Patients diagnosed with the following pulmonary pathology:

  * Pneumonia
  * Pulmonary edema
  * Bronchitis
  * Acute asthmatic attack
  * Emphysema
  * Or Normal (e.g. asymptomatic patients)
* The diagnosis is confirmed if possible, by:

  * Anamnesis
  * Physical examination
  * X-ray
  * Suggestive blood test - CBC
  * Pulse oximetry

Exclusion Criteria:

* Pregnant women
* Chest malformation
* Unconsciousness
* Subject that need a guardian
* Weigh above 150 Kg.
* Patients with current shortness of breath
* Patients currently assisted by breathing machine such as CPAP or other
Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer

This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels

This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels. The subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. These patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. The main treatment is supportive. We would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as colorectal adenocarcinoma pathologically
* Decided by a digestive surgery consultant to be managed with best supportive care
* More than 17 years old and capable of making informed consent
* Karnofsky score \> 50% or ECOG performance status \<=2
* No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer)
* AST \< 2 times normal limit
* ALT \< 2 times normal limit
* Serum Creatinine \< 1,5 times normal limit
* Not pregnant (for women)
* Able to understand and willing participate and to sign informed consent form
* No Diabetes Mellitus
* No fat intolerance
* No severe malnutrition or cancer cachexia

Exclusion Criteria:

* Patient is still on other therapy for the tumour
* Patient with coexisting diseases which prohibits the patient to follow the study protocols
Behavioural Activation (BA) for Postnatal Depression in Blackpool

Is Behavioural Activation feasible, acceptable and potentially effective for mothers experiencing post natal depression in Blackpool?

Phase 1: A series of single case studies which aim to examine and refine a) the appropriateness of the programme to women in Blackpool b) the suitability of BA as part of a stepped-care approach to perinatal mental health within the Health Visitor pathway and c) the delivery of the programme in practice.

Phase 2: A preliminary single group study examining the quantitative outcomes for participating women (i.e. symptoms of depression, anxiety and general mood, parental stress, responsiveness, and behavioural avoidance and activation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Score between 10-19 on PhQ9
* Have given birth within the last 6 months
* Willing to engage in a psychological therapy
* Informed, prepared and safe to participate in the programme
* Able to understand spoken and basic written English

Exclusion Criteria:

* Under 18 years old
* Score under 10 or over 19 on the PHQ9
* Receiving another from of psychological treatment for depression
* Unwilling to engage in a psychological therapy
* Another primary area of difficulty which takes precedence over the current programme (e.g.substance dependency disorders, suicidal crises, frequent, serious and deliberate self-harm, acute threat in the form of serious interpersonal violence from a partner or friend or family member, and evidence of more serious mental health disorders which may require additional support, i.e., psychotic disorders, Bipolar Disorder
A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).


Eligibility Criteria:
Provider Inclusion Criteria:

* Must see adults aged 60 years or older in their practice.
* Must be a prescribing provider.

Exclusion Criteria:

* Provider sees patients at more than one participating study site.
Pain Relief - Tramadol Versus Ibuprofen

The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.

Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.

This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.

As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.

Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.

Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
* They should be adults who are of a sound frame of mind to give an informed consent to participate.

Exclusion Criteria:

* Patients less than 18 years of age
* Patients of unsound mind not capable of giving informed consent
* Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).


Eligibility Criteria:
Key Inclusion Criteria:

* Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
* Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.

Key Exclusion Criteria:

* Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
* Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
* Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock

This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).

Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A).

Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.

Eligibility Criteria:
Inclusion Criteria:

Subjects who are:

1. To be admitted to the intensive care unit
2. At least 18 years of age
3. Men or Women
4. Informed consent from subject or surrogate
5. Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.

Exclusion Criteria:

Subjects with:

1. Body mass index \>37
2. Trauma (primary diagnosis)
3. Pregnancy
4. Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)
5. Known untreated hypothyroidism
6. Known hypersensitivity to medical adhesives
7. Suspected carbon monoxide poisoning or methemoglobinemia
8. Goals of care restricting vital sign acquisition
9. Family member of investigators or study staff
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (\>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 to ≤50 years with the ability to give informed consent.
* Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
* Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
* Gestational age ≥ 35 weeks

Exclusion Criteria:

* Plan for elective cesarean delivery
* Allergy or contraindications to metronidazole
* Receipt of metronidazole or clindamycin on admission for delivery for other indications.
* Hemodialysis
* Severe liver dysfunction
* Patient reports BV to nurse or clinician provider at current clinic visit or has been treated for BV within the past 3 months.
Influence of tDCS on Cortical Plasticity in Healthy Older Adults

The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).


Eligibility Criteria:
Inclusion Criteria:

* right-handed according to the Oldfield Händigkeits inventory (lateralization index \>70)(1971)
* no obvious cognitive impairment (MMSE\>26, Demtect\>13)
* age between 50 and 80 years

Exclusion Criteria:

* Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
* Epilepsy, epileptic seizure in medical history
* Cognitive deficit (MMSE \<20)
* Depressive episode (Beck Depression Inventory (BDI) \> 12)
* intake of centrally active drugs \<3 months , particularly acetylcholinesterase inhibitors
* Pregnancy
* Pacemaker (contraindication for MRI)
* Other metal parts in the body (contraindication for MRI)