cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.

The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject read, discussed and signed the Consent Form,
* Healthy female/male aged 35 65 years,
* Has facial wrinkles,
* Capable of reading, understanding and following instructions of the procedure to be applied,
* Able and willing to comply with the treatment and follow-up schedule.

Exclusion Criteria:

* Listed in approved protocol, and ICF
Treatment of Depression Post-SCI

Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.


Eligibility Criteria:
Inclusion criteria:

1. Age 18 - 70;
2. At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI;
3. Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing;
4. Major depressive disorder, as identified through screening tools;
5. No antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks prior to the study (6 weeks if newly initiated medication).

Exclusion criteria:

1. Concomitant neurologic diseases/disorders or dementia;
2. Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment);
3. History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method);
4. History of psychosis or other Axis I disorder that is primary;
5. Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire);
6. Life expectancy \<1 year;
7. Attempt of suicide in the last 2 years;
8. Electronic or metallic implants (i.e. metal in the head, cochlear implant, or pacemaker);
9. History of seizures or currently prescribed anti-seizure medications;
10. Taking medication that increases the risk of seizures;
11. Pregnancy as identified through a positive pregnancy test;
12. Inability or unwillingness of subject or legal guardian/representative to give informed consent.
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.

Fecal incontinence, also known as accidental bowel leakage, is a common condition that is an immense burden to older women, caregivers, and the health care system. The overall goal of this study is to gather pilot data in order to conduct a future randomized controlled trial (RCT) for a novel treatment for fecal incontinence in older women utilizing fecal microbial transplantation (FMT). The investigator's hypothesis is that infusion of intestinal microbiota from healthy donors to older women with fecal incontinence will increase microbial diversity, reduce symptom severity, and improve quality of life. This study is a single arm, open-label clinical trial of FMT for the treatment of fecal incontinence refractory to conservative management. The investigators will measure the impact of FMT on change in symptom severity and quality of life and stool microbial diversity at 4 and 12 weeks after FMT.

Eligibility Criteria:
Inclusion Criteria:

* Women 50 years of age and older with self-reported fecal incontinence defined as:
* Uncontrolled bothersome loss of liquid or solid fecal material that occurs at least weekly over the last 3 months and
* Failure of response to conservative management using fiber, diet modification, supervised pelvic floor exercises
* Baseline St. Mark's score of greater than or equal to 12
* Intolerance, unwillingness or inadequate response to constipating medications
* Self-reported current negative colon cancer screening based on the 2016 US preventive Services Task Force recommendation (applies to participants age 50-75). N/A if participant is over 75
* Able and willing to sign the informed consent form and agree with study procedures

Exclusion Criteria:

* Known food allergy that could lead to anaphylaxis
* Contraindications to naso-gastric tube placement including:
* Recent mid-face trauma
* History basilar skull fracture
* Recent ENT surgery
* Known coagulation abnormalities
* Esophageal varices and/or esophageal strictures
* Untreated prolapse beyond the hymen
* History of Inflammatory Bowel Disease (does not include IBS)
* Unrepaired rectovaginal fistula/chronic 4th degree laceration
* Full thickness rectal prolapse
* History of congenital anorectal malformation
* History of bowel resection surgery for any indication
* Minor anal procedures within 6 months for treatment of accidental bowel leakage (ABL) (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
* Prior pelvic or abdominal radiation
* Diagnosis of cancer of the descending colon or anus
Effect of Sildenafil on Endothelial Function

We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Eligibility Criteria:
Inclusion Criteria:

* age 40-70
* impotence
* with and without hypertension, Hypercholesteremia or DM

Exclusion Criteria:

* CHF: NYHA \> II
* Stable angina: CCS \> II
* Nitrate treatment
Elderberries and Obesity

Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat oxidation and insulin sensitivity. This study will determine if this is also true with elderberries, which are a more concentrated source of anthocyanins compared to other commonly consumed berries.


Eligibility Criteria:
Inclusion Criteria:

Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.

Exclusion Criteria:

* Are not fully vaccinated against COVID-19 (at least 2-weeks out from final dose at time of staff meeting)
* Have a body mass index less than 25 kg/m2
* Are younger than 22 years of age, or older than 75 years of age
* Pregnant, lactating, or intending to become pregnant during the study period, or have given birth in the past year
* Known allergy or intolerance to elderberries
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
* Adherence to restrictive (vegetarian or vegan) or extreme (fad \[ex. Ketogenic or Atkins\] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
* Habitual use of tobacco or marijuana (including vaping) products in the last 6 months
* Diagnosis or treatment of cancer in the past 3 years
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Type 2 diabetes requiring the use of medication
* Fasting blood glucose \> 125 mg/dL
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients

Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Competent
* The patient should be able to take a sample of p-fluid and urine by himself
* Chronic peritoneal dialysis
* Reads and understand danish
* Has been informed written and oraly about the study and signed informed consent
* P-phosphate koncentrations 0,7-2,0 .mol/l
* P - ioniset calcium 1,1-1,4 mmol/l

Exclusion Criteria:

* Pregnant or breast-feeding
* Terminal patients
* If the experience acute infections or other acute situations they will be excluded from the study
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.

Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

0-6 months infants parents would like to cooperate with the doctors.

Exclusion Criteria:

over 6 months.
Prospective Study of the sensiTVT

sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.

Stress urinary incontinence (SUI) is defined as the involuntary leakage during physical activity and situations that result in an increase of abdominal pressure like sneezing, coughing or laughing and affects up to 25% of women. Currently there are a number of tapes on the market with GYNECARE TVT EXACT® (Tension free Vaginal Tape) and TVT- Obturator being one of the tapes with the highest subjective and objective cure rates and relatively low adverse events in women with normal sphincter pressure. Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed. Data from other tapes are available, however data especially from newer tapes is lacking.

Eligibility Criteria:
Inclusion criteria

* Planned surgery for verified predominant stress urinary incontinence
* women between 18 and 80 years of age
* good German language skills
* informed consent

Exclusion criteria:

* Pregnant or lactating women
* Active surgical treatment for invasive malignant diseases within 3 months
* Contraindications for surgery or anesthesia
* Severe neurologic disease
* Concomitant prolapse surgery
Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

General anesthesia is a medically induced state of low reactivity consciousness involving amnesia, immobility, unconsciousness, and analgesia, which is similar to natural sleep. Its aim is to create a state of sensory deprivation to induce a lack of motor reaction to stimuli and to obtain an explicit amnesia. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have signiﬁcant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Several studies also indicated that circadian rhythms existed in human and controlled by a main internal central clock, the suprachiasmatic nuclei, located in the anterior hypothalamus, which produce and regulate biological rhythms such as sleep arousal, hormones and metabolism could also affect the dose of general anesthesics, which lead to different postoperative recoveries and may have different effects on postoperative sleep quality. Previous studies proved that postoperative sleep disturbances and poor sleep quality are associated with higher postoperative pain, changes in behavior and poor emotional well-being, which could further aggravate postoperative sleep quality. At present, there are few studies which are about the effect of circadian rhythm for different timing of surgery on intraoperative anesthestic requirement, postoperative sleep quality and pain under general anesthesia.

eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the ﬁrst night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and postoperative adverse effect were also recorded

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* American Society of Anaesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

* cardiovascular disease
* long term use of analgesic
* preoperative heart rate (HR) less than 50 beats/min
* second- or third-degree atrioventricular block
* sleep disorder
* sleep apnea syndrome
* history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder did not provide informed consent
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer

The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.

* Trial with surgical intervention

In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.

Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Eligibility Criteria:
Inclusion criteria:

* planned defect reconstruction with free flap and preoperative hematocrit of 28% or below

Exclusion criteria:

* coagulation disorder
* Jehovah's witness
* iodine allergy
* renal or hepatic insufficiency
Thromboprophylaxis in Oesophageal Cancer Patients

The purpose of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.

Hypotheses

1. The intervention group of oesophageal cancer patients, who receive prolonged thromboprophylaxis with Fragmin® has a lower VTE risk, expressed by a lower prothrombin fragment F1+2, 30 days after surgery than the control group, who receive Fragmin® for 10 days.
2. The intervention group does not demonstrate an increased bleeding tendency compared with the control group.

Primary endpoint The primary endpoint is the difference in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group.

Secondary and safety endpoints The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery.

Study design

The study is comprised of three specific objectives, presented in three work packages (WP):

* WP1: Randomization of 100 oesophageal cancer patients undergoing intended curative surgery to either a 10 or 30-day prophylactic LMWH-regime.
* WP2: Investigation of the coagulation in the WP1 population. The aim is to substantially improve understanding of the coagulation pathophysiology and the mechanisms behind the increased thromboembolic risk in oesophageal cancer patients.
* WP3: The lectin pathway complement proteins are suspected to play a role in the increased risk of thrombosis in cancer. We aim to examine this further by measuring complement protein levels in the WP1 population and investigate if there is a correlation between complement levels and changes in the coagulation.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer located in oesophagus and/or cardia.
2. Candidate for intended curative surgery.
3. Age \> 18 years.

Exclusion Criteria:

1. Known inherited bleeding disorder.
2. Unable to provide informed consent.
3. Arterial or venous thromboembolic events within the last three months.
4. On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants).
5. Pregnant or has given birth within the last three months.
6. Known allergy to the trial drug Dalteparin (Fragmin®).
Study of Treatment of Lisfranc Injuries

This trial is designed to compare different treatments on Lisfranc fractures. The trial consist of 2 different strata. Stratum 1: In mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.

The aim of this study is to find out the most effective way to treat Lisfranc injuries

Eligibility Criteria:
Inclusion Criteria:

Stratum 1:

* Nondislocated fractures affecting tarsometatarsal (TMT) joints II and III
* Dislocation \<5mm between medial cuneiforme and base of II metatarsal (MT)
* No fractures affecting TMT joints IV and V

Stratum 2:

* Affected joints TMT II- III + any other TMT
* Any dislocation \>2mm (fracture or TMT joint)
* Dislocation \>5mm between medial cuneiforme and base of II MT

Exclusion Criteria:

* Open fractures
* Extra-articular metatarsal (MT) fractures
* Extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws
* Patients with multiple fractures
* Patients with weak co-operation (dementia, alcohol use, etc.)
* Patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis
* Patients with severe circulatory disorder of the lower limb
* Injuries over 14 days
* Patients with previous foot injury or surgery
* Pregnancy
* Patients who refuse to participate
Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy

With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature.

The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.


Eligibility Criteria:
Inclusion Criteria:

* ASA score ≤ III
* Patients underwent robotic cystectomy

Exclusion Criteria:

* Cerebrovascular disease
* BMI ≥ 30
Adolescent Knowledge of Their Medications

Do adolescents know about their medications?


Eligibility Criteria:
Inclusion Criteria:

* Adolescents between the ages of 12 and 23 who are able to answer questions regarding their prescribed medications (no receptive or expressive disability)

Exclusion Criteria:

* Adolescents outside age range of 12 and 23 who have receptive and/or expressive disability