cyrilzakka/clinical-trials huggingface dataset:
Period Tracker Lay User Study

This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

* Used Clearblue® me Period Tracker app Persona or FAM within the last six months
* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
* Is a qualified or trainee healthcare professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Currently breastfeeding, pregnant or seeking to conceive
* Currently menstruating∆ \*Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.
Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease

This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 yrs
* Severe aortic stenosis or severe aortic regurgitation
* Agree to consent for self
* Can follow-up for the next 2 years

Exclusion Criteria:

* Pre-existing acute kidney injury
* Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy
* On ECMO or IABP
* Life expectancy \< 12 months
* Pregnancy
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C

The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis


Eligibility Criteria:
Inclusion Criteria:

* HIV/ Hepatitic C co infected with documented HCV viremia evidence for cirrhosis and or hepatic fibrosis on liver biopsy, positive fibrosis index, stable health

Exclusion Criteria:

* Decompensated cirrhosis (Child Pugh B or C)
* Pregnant or lactating women
* History of previous antiretrovirals \> 14 days
Quality of Life and Visual Function in Uveitis Patients

The purpose of this study was to measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis.

The National Eye Institute Visual Functioning Questionnaire, version August 2000 (NEI VFQ-25) and the Medical Outcomes Study (MOS) 36 Item Short Form Health Survey Instrument (SF-36) (RAND 36-Item Health Survey 1.0 Questionnaire) will be administered by a trained interviewer. Socio-demographic and clinical data will be collected for additional QOL parameter.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Subjects of either gender
* Age greater than or equal to 18 years of age
* Diagnosed with Uveitis
Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Posttraumatic Stress Disorder

Exclusion Criteria:

* Diagnosis of psychosis, drug- or alcohol dependency/abuse;
* Unable to fill in questionnaires in Dutch;
* Color blindness (Stroop test).
Study on Cognitive Disorders of Multiple Sclerosis

The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m


Eligibility Criteria:
Inclusion Criteria:

* Remitting Multiple Sclerosis defined by Mc Donald et al., 2001
* Patient with authorised immunomodulator treatment or oral immunosuppressive therapy during more than three months: Bétâ Interferon, glatiramer acetate, azathioprine, methotrexate, mycophenolate mofetil, treatment by monoclonal antibody I.V. or anti-VLA4, natalizumab (Tysabri)
* Patient having benefited, possibly, of following treatments : mitoxantrone, cyclophosphamide, cyclosporine, general-purpose immunoglobulins, only if the treatment is ended more of 6 months before the inclusion.
* EDSS score ≤ 5.5
* DRS score ≥ 130
* PASAT 3s score \> 15 and \< median / control subjects according to 2 age brackets, sex, school level.
* Signed the informed consent form.
* Effective contraception for women in age to procreate

Exclusion Criteria:

* Progressive form MS
* MS relapse of less of 4 weeks.
* IV or oral corticoid treatment in the month preceding the screening
* Medicinal treatments or non medicinal in cognitive or psychology-stimulant aim in the 3 months before the screening
* Tumoral form MS visible in the MRI.
* Depressive syndrome (MADRS score \> 19).
* Quite other diagnosed psychiatric pathology
* Known allergy or quite contraindication in memantin : renal or hepatic insufficiency, turned out epileptic disease, treatment by ketamine, amantadin, dextromethorphan, L-Dopa, dopaminergic agonist, barbituric, neuroleptic, 3,4-diaminopyridine, lithium, cimetidine, ranitidine, procainamide, quinine, nicotine, hydrochlorthiazide and ally, phenytoin, modafinil.
* Recent treatment (less of 4 weeks) by antidepressants and/or anxiolytics.
* Pregnancy or feeding.
* Minor or Major "protected by the law" patient
* Uncontrolled diet.
* Patient having benefited of one psychometric assessment(including in particular tests planned in the protocol) since less of one year.
Surgical Tourniquets and Cerebral Emboli

BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England, Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative tourniquet can therefore help to improve the surgical field of view. Although the majority of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are now not pursuing these devices.

There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet is used for TKR surgery. In addition embolic material in the venous system have been observed following TKR surgery and have been noted to be present in the right atrium with transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the result of emboli formed during a TKR. ,

AIM

* Is there evidence of emboli entering the cerebral circulation following tourniquet deflation in TKR surgery?
* Is there evidence of MRI detectable brain lesions and or any clinical change in cognition compared in patients undergoing TKR surgery with a tourniquet compared to those that do not have a tourniquet?


Eligibility Criteria:
Inclusion Criteria:

* i.Aged \>18
* ii.Undergoing elective TKR
* iii.Able to give written informed consent
* iv.No contraindications to MR imaging

Exclusion Criteria:

* i. Ages \<16
* ii. Not able to give written informed consent
* iv. Contraindications to MR imaging
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating potential drug-drug interactions between gemfibrozil (part 1) or dabigatran etexilate (part 2) and camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

* History of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disorder, as judged by the investigator.
Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.

Secondary Objectives:

1. Assess the short- and long-term adverse effects.
2. Determine the radiographic response rate.
3. Determine the overall survival rate.
4. Assess quality of life during treatment

To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
* The tumor must be supratentorial in location
* The planning target volume (tumor plus margin) must measure ≤ 150 cm\^3 in volume
* Age ≥ 18 years
* Life expectancy of at least 12 weeks
* Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria:

* Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
* Tumor foci detected below the tentorium
* Multifocal disease or leptomeningeal spread
* Prior allergic reaction to the study drugs involved in this protocol
* Patients with pacemaker will be allowed to undergo CT instead of MRI
* Pediatric patients (age \< 18), pregnant women, and nursing patients will be excluded
Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation

The aim of this study is to compare the effects of abdominal massage and kinesio taping on constipation severity, quality of life, bowel habits and perception of recovery in women with chronic constipation.

Constipation is not a disease but a subjective symptom characterized by inadequate defecation, the definition of which varies from person to person. It is known that abdominal massage, which is one of the physiotherapy approaches, reduces the severity of gastrointestinal symptoms and increases bowel movements. Kinesio taping applied for constipation can also increase bowel movement, increase the frequency of defecation and decrease the duration of defecation. However, there is a need for studies comparing the effects of these two different applications.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
* Being volunteer

Exclusion Criteria:

* Concomitant colon or gastrointestinal problems
* Body mass index \>35 kg/m2
* Those who have difficulty defecating, those with anorectal dyssynergia
* Being pregnant
* Having neurological, metabolic and/or malignant disease
* Having an open wound, mass, infection and/or hernia in the area to be massaged
* Having abdominal surgery or abdominal radiotherapy in the last 1 year
* Having a mental problem that prevents cooperation
* Taking laxative therapy at least 4 weeks before participating in the study
* To have received physiotherapy and rehabilitation applications related to constipation in the last 1 year
The Effect Evaluation of Laser Acupuncture in Obesity

A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male

Exclusion Criteria:

* Pathmakers user
* Epilepsy history
* Pregnancy
* Immuno-inhibiting agents user
* Malignancy
* Skin contacted disease
* Weight controlled agents user during trial period
* Eating disorder
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®

To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.

The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female which are 18 years of age or older
2. Performance status \< 2
3. Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
4. Postoperative or curative radiation treatment
5. Concurrent chemotherapy is accepted, in head \& neck cancer patients
6. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.

Exclusion Criteria:

1. Pregnant or lactating women
2. Planned to receive concurrent cetuximab
3. Previous radiation therapy on the head and neck area or breast and thorax areas
4. Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
5. Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
6. Use of a tissue-equivalent bolus
7. Use of over-the-counter topical medications containing steroids
8. Presence of rashes or unhealed wounds in the radiation field
9. Recent sun exposure
10. Mental conditions that could adversely affect patients' adherence to the study.
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.

This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating the relative bioavailability of TAS-102 tablets compared to an oral solution in patients with advanced solid tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
3. ECOG performance status of 0 or 1
4. Is able to take medications orally
5. Has adequate organ function (bone marrow, kidney and liver)
6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Certain serious illnesses or medical condition(s)
3. Has had either partial or total gastrectomy
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Known sensitivity to TAS-102 or its components
6. Is a pregnant or lactating female
7. Refuses to use an adequate means of contraception (including male patients)
Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency

The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.

The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.

In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve

Exclusion Criteria:

* Patients with type 1 or 2 diabetes mellitus,
* History of clinical or laboratory evidence of abnormal bleeding,
* Infection at the injection site,
* Allergy to local anesthetic,
* Preexisting central or peripheral muscular or neurological disease (for example: carpal tunnel syndrome)
Extracorporeal Shock Wave Therapy for Dysmenorrhea

purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea

This randomized controlled trial is to determine the effect of shock wave therapy in the treatment of primary dysmenorrhea.

females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification during PD (n=25） GROUP B:dietary modification only (n=25）;

Participants in group B will receive dietary modification for three successive months

The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ages ranged between18 - 25 years old.
2. body mass index (BMI) will not exceed 30kg/m2.
3. females will be diagnosed by the physician as primary dysmenorrhea.

Exclusion Criteria:

1. Secondary dysmenorrhea .
2. Mental health problem such as depression and anxiety.
3. Irregular periods
Telephone Use for Care of Persons With Diabetes Mellitus.

The purpose of this study is to determine whether phone use contributes to diabetes control.

Studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. Recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy This study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão Preto.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 2
* age
* ability to listen and answer questions

Exclusion Criteria:

* often present less than 75% participation in the proposed activities
Prebiotic Effect on Metabolites in Crohn's Disease

The purpose of this study is to investigate the influence of the prebiotic oligofructose enriched inulin on the metabolite pattern in Crohn's disease patients.


Eligibility Criteria:
Inclusion Criteria:

* crohn's disease

Exclusion Criteria:

* severe crohn's disease (harvey bradshaw index \>12)
* pregnancy
* history of colectomy
* use of antibiotics 4-wks before start of the study
* use of sulfapyridine
* use of commercially available prebiotics and probiotics