cyrilzakka/clinical-trials huggingface dataset:
Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage by Transfrontal Keyhole Neuroendoscopy

To compare the prognosis of patients with hypertensive intracerebral hemorrhage treated by two different surgical methods, and to clarify the therapeutic effect of minimally invasive surgery, so as to find a better surgical method that can reduce surgical trauma and mortality and improve the prognosis of patients

In this study, a cohort observation method was adopted to observe a total of 52 patients who underwent two surgical procedures, namely, removal of hematoma in basal ganglo-region by keyhole neuroendoscopy under frontal ultrasound guidance and removal of hematoma by craniotomy microsurgery. They were divided into the endoscopic surgery group and the microsurgery group. In the endoscopic surgery group, 26 patients underwent removal of hematoma in basal ganglo-region by keyhole neuroendoscopy under frontal ultrasound guidance.In the microsurgery group, 26 cases were treated with craniotomy microsurgery for hematoma removal. The clearance rate of surgical hematoma, surgical safety, GCS score, GOS score, nerve fiber injury and postoperative complications were observed in the two groups 1 week, 1 month and 3 months after surgery.To observe and analyze whether endoscopic surgery group has advantages in improving hematoma clearance rate and efficacy

Eligibility Criteria:
Inclusion Criteria:

* CT scan was used to diagnose cerebral hemorrhage in basal ganglia region. The amount of bleeding was 30-50ml, and no cerebral hernia was formed.
* Age between 30 and 70
* The onset is longer than 24 hours and less than 72 hours.
* Informed consent of the patient and/or their relative.

Exclusion Criteria:

* Brain injury, hemorrhage caused by intracranial aneurysm or cerebral arteriovenous malformation.
* Coagulation dysfunction
* Insufficiency of vital organs of heart, liver, kidney or lung
* Previous history of stroke with functional loss
* Intracranial or systemic infection
* Poor blood pressure control
Anxiety of Patient and His Partner During Admission to Emergency Department

Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department

Admission to an emergency department is a major source of anxiety for the patient. Anxiety plays not only a role in its emotional state but can also have consequences on the taking care of the patient and especially on the analgesic procedure.

Since pain is one of the first causes of emergency admission, patient anxiety should not be overlooked. In the emergency department, patient consults frequently, with his partner . Anxiety can also affect the partner, which may affect the patient. No studies have yet demonstrated this correlation.

This study will evaluate, the anxiety of both parties and show the presence or not of an influence of the partner's anxiety on the patient using a standardized questionnaire, the State-Trait Anxiety Inventory- form Y (STAI-Y).

Eligibility Criteria:
Inclusion Criteria:

* Admission to emergency department accompanied by his partner (lives in concubinage with the patient)
* Nurse patient's classification score up or equal to 3, 4 or 5
* Oral consent given to the inclusion by the patient and the partner
* Patient and partner Francophone or with a good understanding of French

Exclusion Criteria:

* Patient under a system of legal protection
* Non-Communicating Patient and partner
* Patient and partner unable to write
* Refusal of patient or partner
* Admission of the patient with shock treatment corresponding to the nurse patient's classification score 1 and 2
The Effect of Backward Walking Treadmill Training on Balance in Patient With Chronic Stroke

The purpose of this research was to discuss the effect of backward walking treadmill training on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic stroke.

Walking training is a good method and strategy to improve postural stability, balance, gait symmetry, and increase walking ability. Generally, there are many walking training theories and methods for patients with chronic stroke and treadmill walking training is applied in recent years. Previous studies showed that patients with stroke improve the walking abilities and speed after the walking treadmill training. However, most studies have demonstrated that forward walking treadmill training improved balance and walking ability in patients with stroke, but fewer studies have investigated the effects on backward walking treadmill training. However, no studies to date have investigated the effects of backward walking treadmill training for patients with chronic stroke.

Eligibility Criteria:
Inclusion Criteria:

* This experiment recruited subjects with chronic stroke more than six months, whose level of Brunnstrom stage was beyond IV and who were able to walk more than eleven meters with or without assistive devices

Exclusion Criteria:
Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach

Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.


Eligibility Criteria:
Inclusion Criteria:

Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.

Severe peri-implantitis will be defined as peri-implant probing pocket depth \[PPD\] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing \[BoP and/or SoP, respectively\] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.

Exclusion Criteria:

Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.

Systemic primary exclusion criteria:

* compromised general health which contraindicates the study procedures (ASA IV-VI patients);
* systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus);
* pregnant or nursing women;
* chronic use of corticosteroids or NSAID or immune-modulator drugs (any type and any dose);
* patients who need use of medications affecting bone metabolism or peri-implant mucosa (bisphosphonates, any type and any dose).

Local primary exclusion criteria:

* history of peri-implantitis treatment on implants to be included in the study (included topical antibiotics);
* hopeless implants (e.g. mobility) to be included in the study.

Secondary exclusion criteria:

- uncompliant patients (poor oral hygiene 2 weeks after OHI).
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

OBJECTIVES:

I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.

Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology
* Crohn's Disease Activity Index (CDAI) must be between 150 and 450
* No ulcerative or infectious colitis or severe perianal disease

--Prior/Concurrent Therapy--

* Biologic therapy: Not specified
* Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed
* Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs
* Radiotherapy: Not specified
* Surgery: No impending surgery No prior ileostomy or colostomy
* Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin

--Patient Characteristics--

* Age: 18 to 80
* Performance status: Ambulatory
* Hematopoietic: Not specified
* Hepatic: No hepatic disease
* Renal: No renal disease
* Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy
Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth

The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Obstetric laceration requiring suturing

Exclusion Criteria:

* \< 18 years old
Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix

The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Desire to mitigate postoperative presbyopia with implantation of Synergy IOL in one eye and PanOptix Trifocal IOL in the opposite eye

Exclusion Criteria:

* Any vision-limiting problems (e.g., corneal, retinal, infection) which can potentially limit post-operative visual performance
* Any ocular condition or trauma that is not resolved, stable, or would compromise the well-being of the subject
Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions

Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these compounds have displayed both in vitro and in vivo antioxidant activity.

Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.

Design: Single-blind, controlled and randomized clinical trial including 100 healthy men, divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark chocolate/d for 1 wk, and the other 50 subjects received placebo.

Adult young males were enrolled at the Universidad Industrial de Santander by publicity at the university food service centre. Those who respond (n=136) were selected after the normal blood lipid profile was verified by laboratory testing of total cholesterol, LDL, HDL, VLDL and triacylglycerols, as well exclusion and inclusion criteria were applied. Within the exclusion criteria we included diagnosed coronary artery disease, diabetes mellitus, arterial hypertension, use of any prescribed medication, restrictive diets and any migraine or cocoa products allergic antecedents.

Finally enlisted subjects were 120 non-smokers, normolipemic, ages were between 20 and 30 years old, who underwent anthropometric measurements like weight, height, BMI (among 16.0 and 27.4 kg/m2) and regular nutritional and toxicological habits using standardized surveys. Subjects received 3 meals a day from the Food Nutritional Service of Universidad Industrial de Santander, in order to ensure the same diet conditions for all subjects along the experimental period. An average colombian diet, based on 2287 calories as a total caloric value (protein 15%, fats 35% and carbohydrates 60%) was used. The study protocol and the informed consent were approved by the Fundación Santa Fe de Bogotá Institutional Ethical Committee (Santa Fe de Bogotá D.C., Colombia). We got written informed consent from all participants and they received money compensation for its participation in the study.

Outcome measures:

Susceptibility of plasma lipids to oxidation Determination of plasma lipids oxidation resistance Determination of oxidative protection

Eligibility Criteria:
Inclusion Criteria:

* Normal lipid profile
* Age between 20 and 30 years old
* Must like chocolate

Exclusion Criteria:

* Diagnosed coronary artery disease
* Diabetes mellitus
* Hypertension
* Use of any prescribed medication
* Restrictive diets and any
* Migraine or
* Cocoa products allergic antecedents
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
* lateral position for spinal anesthesia in femur proximal fracture patients

* Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
* After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
* pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
* When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
* Patients will be injected propofol 10mg when they have agitation signs during operation.
* vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists classification 1-3 patients
* \>20 years old

Exclusion Criteria:

* patients refuse
* dementia patients, cooperation difficult patients
* anaphylaxis of dexmedetomidine, ketamine, local anesthetics
* heart problem (bradycardia, atrioventricular block)
Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).

Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of \<0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Female
* 11 years of schooling
* 12 cut-off at Waterloo-Stanford Group C (WSGC)

Exclusion Criteria:

* hearing loss subjects
* formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)
Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS

The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations.

The research has the following aims:

* Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated;
* Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and
* Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.

The goal of this research is to establish best practices to address overdose risk in people exiting incarceration, people living with HIV/AIDS (PLWHA), and both populations simultaneously. This contribution is important because this evidence has applications for correctional facilities and HIV clinical practice throughout the United States. The contributions of the proposed pilot study are: to provide evidence on the effectiveness of a targeted intervention on these two high-risk groups, generate exploratory data on predictors of overdose risk specific to HIV status and recent incarceration, and provide context about overdose risk and responses to witnessed overdoses in the first month after release.

In this study, incarcerated PLWHA in the Philadelphia Department of Prisons will be offered overdose training while incarcerated and naloxone (Narcan) at release. Study participants will be given a pre-test on overdose knowledge and attitudes and receive the overdose prevention intervention. Those who are still incarcerated one month later will receive a post-test on overdose knowledge and attitudes. Approximately one month after study participants are released from jail, they will be given a one-month follow-up survey that assesses: overdose knowledge and attitudes (post-test 2), information on personal or witnessed overdoses since release, health and post-incarceration related information, and characteristics of drug use since release. Approximately 20 study participants will participate in a semi-structured interview 4-6 weeks after their release on their experiences with the overdose prevention intervention.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Age 18 and over
* Speaks English
* plans to live in Philadelphia area after release

Exclusion Criteria:

* More than 10 months remaining on a sentence or release date unknown
Effect of Dry Needling on Surface Electromyographic Activity in Latent Trigger Points

Brief summary: The purpose of this study is to determine the effect of Dry Needling (DN) on electromyographic activity in different situations at the latent trigger point (LTrP) point of the upper trapezius. Randomized controlled trial, in parallel with the crossover control design. Two groups with LTrP in the upper trapezius, and the DN group or the Sham-Dn group will be randomly selected.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years
* The presence of LTrP in the middle third of the upper trapezius muscle onthe dominant side
* Being able to provide written informed consent
* Being able to follow instructions and realize clinical tests

Exclusion Criteria:

* Any pharmacological therapeutic
* Any medical treatment or physical therapies at cervical region during the 6-month before this study
* Any diagnosed health problem
* Any history of head and upper extremity surgery or trauma
* Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia,Infection, cancer)• Absence of recurrent history of neck pain
* No neck pain symptomatology the previous 6 months
* Cervical disk herniation
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.

The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
* Daytime urgency incontinence at least once/day

Exclusion Criteria:

* Daytime voiding frequency less than 5
* Uroflow indicative of pathology other than OAB
* Maximum voided volume \> age expected capacity (\[age +1\] x 30) in ml
* Post voiding residual (PVR) \> 10% of the functional bladder capacity
* Monosymptomatic enuresis
* Congenital anomalies of the genito-urinary tract or nervous system
* Current constipation (when treated the patient can enter the study)
* Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
* Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN