cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Silk'n Glide for Face

This is a clinical study to determine the efficacy and safety of the Glide, hair removal photo-depilation device, for removing facial hairs. During the first stage, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.

Study efficacy assessment:

Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.

Study safety assessment:

1. Reported errors and near errors using the device
2. Device malfunctions which relate to device safety
3. Device related adverse events
4. Non device related adverse events (secondary endpoint)

Eligibility Criteria:
Inclusion Criteria:

1. Presence of unwanted hairs on the face
2. Skin Type I to IV (Fitzpatrick)
3. Adults older than 21 years of age but not more than 60 years of age.
4. Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
5. Informed consent agreement by the subject.
6. Willingness to follow the treatment schedule and post treatment care.

Exclusion Criteria:

1. Malignant or pre-malignant pigmented lesions in the area to be treated.
2. Scarring or infection of the area to be treated.
3. Known photosensitivity.
4. Pregnancy or lactating
5. Subjects with Diabetes (Type I or II).
6. Presence of a suntan in the area to be treated.
7. Use of medication known to induce photosensitivity.
8. Subject is on anticoagulative medication or throm-boembolic condition.
9. Subjects with a pacemaker or internal defibrillator.
10. Use of NSAIDS two weeks prior to, and two weeks following the treatment.
11. Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
12. Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
13. Subjects wearing a tattoo or permanent makeup on the area to be treated
14. Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
15. Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
16. Subjects with history of keloidal scar formation
17. Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
18. Subjects with epilepsy
19. Subjects using incontinence device, insulin pump, other active devices \[NB: Protocol excludes pace-makers and internal defibrillators.\]
20. Subjects with a history of skin cancer or areas of po-tential skin malignancies
21. Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)


Eligibility Criteria:
Inclusion Criteria:

* PTSD (DSM-5 criteria)
* Stable allowed medications with no planned changes from 30 days prior to screening through study participation
* Willing to use highly effective birth control
* Willing to comply with protocol visits and procedures

Exclusion Criteria:

* Moderate to severe traumatic brain injury
* Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders
* Substance use disorder or alcohol use disorder within 6 months prior to screening
* Psychotherapy or cognitive based therapy within 30 days prior to screening
* Use of investigational drug within 30 days prior to screening
* Prior participation in study of NYX-783, NYX-2925 or NYX-458.
Using Virtual Technologies to Prevent Injuries in Adolescents With Acquired Brain Injury

The objective of this study is to identify home safety hazards for adolescents with acquired brain injury and to identify adaptations to the home healthcare virtual simulation training system (HH-VSTS) to improve the user experience for adolescents with ABI

This study will determine the home safety hazards that place adolescents with ABI at risk of injury. In addition, the study will determine ways to adapt our current home safety virtual simulation training system, a game based training and assessment that trains home healthcare workers to identify and respond to hazards they encounter in client homes. The study will include interviews with three stakeholders groups: adolescents with ABI, parents of adolescents with ABI, and healthcare providers working with adolescents with ABI to identify home safety hazards encountered by adolescents with ABI. We will demonstrate proof of concept for adolescents with ABI through assessment of safety concerns from multiple perspectives and evaluation of design considerations from our intended user-group. Further, we are applying the HH-VSTS in a novel way to solve an understudied problem in adolescents with ABI. In addition, we will apply a user-centered, participatory approach to assess the design consideration of virtual gaming technologies to health and safety training adolescents with ABI.

Eligibility Criteria:
Inclusion Criteria:

1. adolescent with an acquired brain injury between the ages of 12 - 17 (TBI diagnosis per medical record or self-report for those recruited via word of mouth or community) OR
2. parent/caregiver (18+ years of age) of an adolescent with an acquired brain injury OR
3. a health professional involved in discharge planning and community re-integration of adolescents with an acquired brain injury.
4. For online interview, must have access to a computer or smart tablet with reliable internet access, a microphone, a video camera, and speakers, headphones
5. Speak and read English
6. Able to answer interviewer questions
Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.


Eligibility Criteria:
Inclusion Criteria:

* T1DM for at least 12 months
* persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy,
* recurrent severe hypoglycemic episodes or high glucose variability
* willingness to wear the insulin pump

Exclusion Criteria:

* previous use of insulin pump
* pregnancy or planning to become pregnant in the next 2 years,
* lack of ability to use the study devices
* history of severe chronic diseases
* recent or concomitant use of corticosteroids
* drug or alcohol abuse
* psychiatric complaints that interfere with the correct use of the devices
Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

* Open-label,randomized, multicenter;
* Maximal experiment duration: 8 weeks;
* 04 visits;
* Safety and efficacy evaluation

Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes aged between 18 and 65 years;
* Participants diagnosed with uncontrolled hypertension;
* Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .

Exclusion Criteria:

* Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
* Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
* participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;
* participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
* research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position);
* History of congestive heart failure (CHF) functional class III or IV (NYHA);;
* any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;
* Creatine phosphokinase (CPK) levels above the established laboratory normal range;
* Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;
* Body mass index (BMI) ≥35 kg / m²;
* Immunocompromised participants (eg .: malignancies, patients with Acquired Immunodeficiency Syndrome etc);
* Chronic use of drugs that may interact with the drugs of the study;
* Patients on concomitant lipid-lowering therapy;
* History hypersensitivity to the active ingredients used in the study;
* Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;
* History of alcohol abuse or illicit drug use;
* Adherence to uniformization medication \<80%;
* Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease

Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.

The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population


Eligibility Criteria:
Inclusion Criteria:

* Men and Women (age range 23-64 y)
* BMI of 18-30kg/m2
* Fasting glucose concentration \>5.5 but \<7.5mmol/L
* Total cholesterol \>5.2 but \<7.8mmol/L

Exclusion Criteria:

* medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
* use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
* exposure to any investigational agent \<42 d before the study
* presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
* history of substance misuse or alcoholism
* current pregnancy, planned pregnancy, or given birth in the past 12 months
* antibiotic treatment 6 weeks previous to study start date
* allergy or intolerance to intervention breakfast cereals components
* smoking
Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year

The growing interest of patients in esthetic procedures, as well as the development of less invasive protocols in dentistry, has promoted the development of treatment plans that include stability, harmony, and function in orofacial rehabilitation.

Poor esthetics interfere with an individual's personal, social, and professional relationships and is an individual consideration that varies according to the patient's age, time, region, and culture concerning what is considered beautiful.

People are increasingly being inspired to get more corrective and cosmetic surgeries as an esthetic smile becomes a more fundamental component of what it means to be beautiful.

There are several variables that affect how appealing and esthetic a smile is Esthetic perception varies according to cultural, societal, environmental, and individual factors like experience and educational level Previous studies have shown that a smile with less gingival display (GD) is viewed as more beautiful, with dental professionals being more critical of gingival presentation than laypeople According to research by several authors, the ideal GD ranges from 1 to 3 mm While many factors influence how pleasant a smile is seen, excessive GD (EGD), sometimes referred to as a gummy smile, is regarded as a key factor in smile analysis and one of the main issues connected to an unsatisfactory dental smile.

To reduce the relapse associated with repositioning surgery and to provide a lasting treatment without the need for reapplication, as in the case of the toxin, a combined treatment using the toxin preoperatively was considered.

Eligibility Criteria:
Inclusion Criteria:

* Patients that is not satisfied with his smile having excessive gingival display
* Adult Age ≥ 21 years.
* Systemically and periodontally Healthy patients.
* had gingival exposure greater than 3 mm when smiling
* had a hyperactive upper lip with or without other causes of EGD (lip displacement ≥ 9 mm) before botox \& ≥ 3mm after.
* Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

* • smoking

  * pregnancy or lactation
  * Systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication
  * Patients having medical condition or any drugs that could affect healing
  * Patients with systemic condition that can't undergo minor oral surgery
  * Patient allergic to Botox or multiple allergic conditions
  * have history of previous Botox injection
  * periodontal disease
  * excessive gingival display at rest
  * those who declined the informed consent or who did not consent to the risks described.
  * Those who have deviate smile
Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.


Eligibility Criteria:
Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
* patients scheduled for laparoscopic nephron sparing surgery
* patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

* patients' aged \>80 years
* patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
* patients not able to tolerate the laparoscopic procedure
* patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney
* patients with the renal tumor involving urinary collecting system
Subcutaneous Sterile Water Injection for Relief of Low Back Pain

To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Study sample:

The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)

Setting:

Labor ward in Women's health center at Assiut university hospital

Study design:

Experimental Randomized control study

Sample size:

The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria

* In labour (spontaneous or induced
* During first stageof labour
* Primary and multiparous women
* A term singleton pregnancy (between 37 + 0 and 41 weeks)
* Have a fetus in a cephalic presentation
* Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
* Provide informed consent.

Exclusion criteria

* Multiple pregnancy
* Malpresentation (breech, transverse, shoulder)
* Previous CS
* Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

Study Tools:

1. Personal data questionnaire
2. Visual Analogue Scale and Face analogue scale
3. Satisfaction scale

Eligibility Criteria:
Inclusion Criteria:

* In labour (spontaneous or induced record
* During first stage of labour
* Primary and multiparous women
* A term singleton pregnancy (between 37 + 0 and 41 weeks)
* Have a fetus in a cephalic presentation
* Experience back pain assessed by visual analogue scale VAS and Face pain analogue
* Provide informed consent.

Exclusion Criteria:

* Women with chronic disease
* Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
* Complicated labor process ( obstructed, preterm labor, twins)
Rule-Based Closed Loop System for Type 1 Diabetes Control

The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast.

The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Insulin pump treatment
* Undetectable C-Peptide

Exclusion Criteria:

* Autonomous system neuropathy
Impact of Practitioner and Instructional Set on Subject Perceptions and Expectations of Cervical Spine Manipulation

Determine effects of perceptions and expectations on experience of cervical spine manipulation

The purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. Current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-65 years;
2. must report having no current episode of mechanical neck pain;
3. must be willing to participate;
4. must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years.

Exclusion Criteria:

1. 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke.
2. History of neck whiplash injury.
3. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms.
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes.
5. Evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck).
6. Prior surgery to your neck or upper back.
7. A medical condition which may change your sensation of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency).
8. Diagnosis from your physician of fibromyalgia syndrome.
9. Currently pregnant, or think you may be pregnant.
Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

The immunoreactivity to CD3+ and NKp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for CLM between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. The survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

Eligibility Criteria:
Inclusion Criteria:

* histological proven colorectal liver metastases
* complete clinical, surgical, pathological and follow-up data

Exclusion Criteria:

* non-radical surgery
* incomplete clinical, surgical, pathological and follow-up data