cyrilzakka/clinical-trials huggingface dataset:
Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults

The purpose is to study the effect of chiropractic care on balance in older adults.

The specific aims of this pilot study are to: 1) build a recruitment pool of older adults within the local community; 2) establish a protocol for long-term surveillance of falls for older adult chiropractic patients; 3) explore dose-response patterns to chiropractic care by comparing Berg Balance Scale scores at 12 months from baseline in three groups of older adults with impaired balance.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 or older
2. Able to stand steadily without assistance on one leg for an average of \<5 seconds (determined by averaging the time for both legs)
3. Able to attend all scheduled sessions (by self-report)

Exclusion Criteria:

1. Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded
2. received chiropractic care or other manual care within the past three months (by self-report)
3. initiated exercise program for balance / lower body strength within the past month (by self-report)
4. contraindications to SMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications include but are not limited to: signs and symptoms associated with vertebrobasilar insufficiency (including facial numbness, diplopia, drop attacks, dysphagia, and ataxia which are not fatiguable or habituable with repeated provocative head positioning); unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", i.e. persons with known severe cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
5. absence of indications for SMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for SMT include identification of decreased or increased spinal joint mobility usually accompanied by tenderness and muscle tension and spasm;
6. unable to understand English adequately to complete study forms and questionnaires, because we do not have study personnel fluent in other languages;
7. central causes of vertigo, including arteriovenous malformations, cerebral hemorrhage, brainstem vascular disease, tumors and demyelenating diseases.
Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. POH affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. The most commonly affected people are those with the highest skin phototypes. Although the prevalence is similar between sexes and age groups, POH is a more frequent complaint in women. The dark circles characteristic of POH can negatively impact patients' quality of life, although it is not a condition associated with morbidity. Popularly it is believed that the poor quality of sleep is a factor responsible for its appearance, but there is no consistent data in the literature that prove this.

We aim to compare the quality of sleep through the Pittsburgh Sleep Quality Index (PSQI-BR) already translated and validated in Portuguese for patients with periorbicular hyperchromia (cases) with patients without this complaint (controls) and to compare dermatological quality of life through the Quality of Life in Dermatology Index (DLQI) already translated and validated for Portuguese patients with periorbicular hyperchromia (cases) with patients without this complaint (controls). Patients and / or family members who consult in the Dermatology of the Hospital de Clínicas of Porto Alegre (preferably), but also other patients and / or relatives with outpatient care in this institution will be invited to participate in the control group.

The WinPepi program, version 11.32, was used to calculate the sample size. This objective predicts a Pareto Control Case study by age, with a ratio of 1: 1. The sample size was 252 subjects, 126 cases and 126 controls. Adding 10% to possible losses and refusals the sample size should be 280 subjects, with 140 cases and 140 controls. This value was stipulated taking into account the mean of 5.9 in the PSQI-BR of the cases already collected (n = 148 subjects) and corresponds to a difference of almost 3 points in the index ranging from zero to 21, corresponding to approximately 15% difference between groups. For this calculation was considered 80% power and significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Patients with periocular hyperchromia diagnosed by clinical examination.
* Controls: Patients without periocular hyperchromia diagnosed by clinical examination.

Exclusion Criteria:

* Pregnant patients
* Active collagenase patients
* Patients with bacterial or viral infections on the periorbicular area
* Patients undergoing any treatment modality for periocular hyperpigmentation in the last 3 months.
Nerve Growth Factor in Chronic Pancreatitis

This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.

Hypothesis:

1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with established CP and none of the exclusion criteria mention below.

Exclusion Criteria:

* Failure to obtain consent.
* Any comorbid condition with expected survival \< 1 year.
* Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.
* Patients \< 18 years of age at time of consent
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for cataract surgery

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates
Pilot RCT of Self-stigma Treatment for First Episode Psychosis

The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.

The investigators will conduct a small RCT of the modified intervention (NECT-YA), combined with CSC, in comparison with CSC alone, with 40 persons recruited from three FEP programs, assessing acceptability and feasibility, and collecting data on primary outcome (service engagement and therapeutic alliance), related outcomes (self-esteem, hopelessness, and social functioning) and mechanisms of action (self-stigma, illness conceptions and coping). The investigators will also collect qualitative data on participants' impressions of NECT-YA, which will inform additional revisions of the manual.

Eligibility Criteria:
Inclusion Criteria:

1. Meets criteria for FEP youth based on the following definition: age 15-24, onset of psychotic symptoms within the last 5 years, and an absence of a primary substance use or mood disorder that could be causing the psychotic symptoms (confirmed by program eligibility);
2. Meets criteria for moderate (defined as a mean score of 1-1.5 on the 0-3 scale of the Internalized Stigma of Mental lllness Scale \[ISMI\]) or elevated (defined as a mean score of 1.5-3 on the 0-3 scale of the ISMI) self-stigma;
3. Speaks English well enough to complete assessments and participate in groups;
4. Is able to provide informed consent to participate.

Exclusion Criteria:

Does not meet any of the above inclusion criteria.
Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial

To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who had lower anterior irregularity (crowding, rotation, buccally or lingually displaced) will be selected.
2. Good oral hygiene, healthy gingiva and no evidence of bone loss as seen on the radiograph.
3. Healthy systemic conditions.
4. Patients pass the growth spurt according to cervical vertebral maturation method as described by Baccetti et al.
5. Availability of good quality records at pretreatment and post-treatment.

Exclusion Criteria:

1. Patients that has any signs of active periodontal disease or evidence of bone loss on the radiograph.
2. Patients with systemic disease such as osteoporosis and diabetes.
3. Smoking patients.
4. Study casts did not include all mandibular permanent incisors, canines, and first molars.
Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

The project uses virtual reality technology to recreate situations that cause freezing of gait in individuals with Parkinson's disease. Individuals who underwent deep brain stimulator (DBS) surgery for Parkinson's disease will walk through a virtual reality environment while brain signals are recorded from the DBS device. The goal is to better understand what occurs in the brain during freezing of gait.

Falls related to problems with posture and walking as well as freezing of gait (FOG) occur in nearly 80% of people with Parkinson's disease (PD). Despite falls occurring in the daily lives of people with PD, it is difficult to produce FOG episodes in a doctor's office or other clinical setting. We will therefore use virtual reality to create an environment that can consistently produce FOG episodes in people with PD. By purposely producing FOG while people are wearing equipment that monitors brain activity, we can see where in the brain FOG is triggered. Study participants will be asked to wear a virtual reality (VR) headset and heart rate monitor and walk on a treadmill that permits users to start, stop, and turn, allowing them to naturally walk through a virtual environment. We will record the activity from the DBS system while participants perform the tasks. Participants will also complete clinical assessments of PD, a FOG questionnaire and cognitive tests that include naming objects and recalling items from a list.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic PD
* Undergoing scheduled surgery for bilateral STN-DBS at a Cleveland Clinic facility or previously undergone STN-DBS surgery with the Medtronic Percept BrainSense DBS system
* Self-reported response of one or greater on question #3 of the Freezing of Gait Questionnaire (FOG-Q)
* Ability to walk independently for a minimum of 10 minutes
* Ability to provide informed consent

Exclusion Criteria:

* Neurological disease other than PD, such as stroke or multiple sclerosis
* Musculoskeletal impairment that affects one's ability to ambulate
* Presence of active and untreated psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder. Depression and anxiety are very common in patients with Parkinson's disease and are often mitigated as part of routine care. Depression and anxiety will not preclude study participation
* Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation
* Current alcohol or substance abuse
* Hearing or visual impairment precluding VR use
* Lack of fluency in English which may invalidate certain tests
FaReWell Depression - Facial Exercise Program to Treat Depression

This study investigates if a physiotherapeutic exercise program designed to relax facial muscles associated with the expression of negative emotions and to activate and strengthen facial muscles associated with the expression of positive emotions can reduce the symptoms of depression and improve wellbeing and quality of life in the affected patients.

Activity of the facial musculature expresses emotions, but also generates proprioceptive signals to the emotional brain that maintain and reinforce the expressed emotions. This has been described by Charles Darwin and William James in the facial feedback hypothesis.

Studies have shown that interruption of facial feedback by the injection of botulinum toxin into the corrugator and procerus muscles, which express negative emotions like sadness, anger, and fear, can reduce the symptoms of depression.

In the present study we investigate, if similar effects can be achieved by a relaxing massage of these and other muscles that are associated with the expression of negative emotions and if strengthening exercises of muscles that express positive emotions, the zygomaticus and orbicularis oculi muscles, can contribute to the rehabilitation of positive emotionality in depression. After instruction by a physiotherapist, participants will practice the exercises daily for 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate unipolar depression
* Stable treatment for at least 6 weeks

Exclusion Criteria:

* Organic mental disorders
* Mental disorders due to psychoactive substance use
* Schizophrenia and other psychotic disorders
* Previous cosmetic procedures (botulinum toxin, fillers, lifting)
* Facial palsy
* Facial skin disorders
Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis

This is a randomized controlled trial comparing the trial hygiene wash against placebo wash as adjunct treatment with oral metronidazole in women with bacterial vaginosis, with microbial analysis of vaginal flora compared to healthy control women

Eligibility Criteria:
Inclusion Criteria:

* 1. premenopausal women who are sexually active 2.willing to use hygiene wash together with prescribed oral antibiotics 3. able to undergo pelvic examination for sampling of vaginal discharge

Exclusion Criteria:

* 1. Unable to comply with pelvic examination or hygiene wash 2. Concurrent use of hormonal treatment or antibiotic therapy 3. Intrauterine device either copper or levonorgestrel-releasing system 4. Women with known diabetes mellitus 5. Pregnant women
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.

The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:

1. renal hemodynamics (renal plasma flow and glomerular filtration rate)
2. renal sodium excretion
3. lithium clearance and fractional lithium excretion
4. plasma levels of vasoactive hormones
5. blood pressure and heart rate

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension (blood pressure \> 140/90) with no signs of secondary hypertension
* P-creatinine \< 200 µmol/L

Exclusion Criteria:

* Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult
* Medication except antihypertensives
* Drug or alcohol abuse
* Pregnancy
Continuous Use of the Contraceptive Patch and the Personal Economic Impact.

Dr. Eleanor Drey in the Department of Obstetrics, Gynecology and Reproductive Sciences UCSF is conducting a study to examine the personal and economic impact of continuous use of ORTHO EVRA, the contraceptive patch, on menstrual related symptoms for women who report having severe menstrual related symptoms.

30 adult women, 18-40 years of age, will be recruited to participate in a six month study. The focus of recruitment will be on women with menstrual-related symptoms who are currently working in physically demanding, low autonomous service jobs.

The approximate first two months of women's participation will be spent documenting baseline information about their health and well-being, work patterns and performance, and the economic impact of their menstruation. Subjects will then initiate two, two month intervals of continuous use of ORTHO EVRA.

Over this four month treatment period, subjects will document their health and well-being, work patterns and performance, and the economic impact of their menstruation while being treated with ORTHO EVRA. This will allow us to compare subjects' experiences pre- and post-treatment. The study's instruments will focus on eliciting information on the personal and economic costs of menstruation such as measuring time missed from work, changes in productivity and work satisfaction, and impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, women 18 through 40 years of age at the time of enrollment who have severe menstrual related symptoms
* Willing and able to comply with the study protocol
* Has not used oral contraceptives, vaginal rings, or injectable contraceptives during the last month and has had one regular menstrual period preceding enrollment OR is within seven days post induced abortion
* Has been determined to be eligible for hormonal contraceptive use
* Willing and able to be contacted by research staff.

Exclusion Criteria:

* Does not speak or read English
* Is breastfeeding
* Has contraindications to use of estrogen-containing contraceptives including thrombophlebitis or thromboembolic disorders including a past history of deep vein thrombophlebitis or thromboembolic disorders
* Cerebrovascular or coronary artery disease
* Known or suspected carcinoma of the breast, endometrium or suspected estrogen-dependent neoplasia
* Undiagnosed abnormal genital bleeding
* Biliary tract disease
* Cholestatic jaundice of pregnancy or jaundice with prior contraceptive steroid use
* Hepatitis
* Cirrhosis
* Hepatic adenomas or carcinoma
* Hypertension (\>140 systolic or \>90 diastolic)
* Diabetes
* Migraine with focal neurologic symptoms
* Is pregnant or less than 3 months postpartum
* Concurrent use of medications that induce liver enzymes
* Has severe or chronic constipation
* Drug or alcohol abuse (current or within the last 12 months)
* Unable or unwilling to comply with protocol
* Is HIV-positive
* Has history or presence of cancer
* Treatment (other than hormonal contraception) has been recommended for menstrual symptoms
* Taking prescription medication because of menstrual related symptoms
Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.

The aim of the study is to assess the impact of the rehabilitation and treatment stay at the underground Health Resort of the 'Wieliczka' Salt Mine in Wieliczka on the functional capacity, respiratory parameters, and rheological properties of blood in elderly individuals with respiratory diseases.

The research project will involve patients aged 65 and older with chronic respiratory diseases. Based on controlled studies conducted at the Health Resort "Wieliczka" Salt Mine in Wieliczka, and assuming the project will be a prospective, experimental, controlled study with a crossover design, calculations were made for the primary variable under investigation (exercise tolerance). These calculations determined that 29 pairs of participants are needed to achieve a statistical power of 80% and a significance level of 5% (bilateral). To detect a mean difference between pairs of 58, assuming a standard deviation of 106 for these differences and accounting for a 10% loss of participants from observation, the required sample size was increased to 33 pairs. Given the crossover design, the study plans to include 33 patients.

Volunteers will undergo qualifying tests, measurements of functional fitness, respiratory indicators, and blood rheology tests 3 weeks prior to the start of the rehabilitation and therapeutic stay in the underground salt chambers (1st test). During the 3-week period before the rehabilitation, participants will not engage in any other form of therapeutic rehabilitation. Functional fitness, respiratory indicators, and blood rheology tests will be repeated before the start of the stay (2nd test), immediately after its completion (3rd test), and 3 months after its completion (4th follow-up test). Each day of the rehabilitation and therapeutic stay will include a 2.5-hour visit to the underground health resort under the supervision of a doctor, physiotherapist, and nurse, during which pulmonary rehabilitation will be implemented.

Eligibility Criteria:
Inclusion Criteria:

* people aged 65 and older with chronic respiratory diseases in a stable period of the disease (without exacerbations), qualified to participate in a rehabilitation and treatment stay in the underground Health Resort 'Wieliczka' Salt Mine in Wieliczka,
* patients who gave informed, written consent to participate in the study.

Exclusion Criteria:

* patients with contraindications to subterraneotherapy and physical exercise,
* lack of written consent to participate in the study,
* deterioration of health during the implementation of the program.
Laser Hair Removal for Treatment of Pilonidal Disease

This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.

This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention:

* Experience two or more episodes of infection or abscess in the past 12 months
* Have pain or drainage for a total of more than 1 month in the past 12 months
* Missed a total of more than 1 week of school or work in the past 12 months
* English-speaking

Exclusion Criteria:

* Patients who have co-morbidities that prevent them from becoming a surgical candidate

  * Previous history of laser hair removal in the gluteal cleft (prior to initial enrollment)
  * Previous excision of pilonidal sinus (prior to initial enrollment)
  * Non-English speaking
A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation

The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .

In classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate rectal prolapse
* Singed informed consent.

Exclusion Criteria:

* Huge rectal prolapse .
* Recurrent rectal prolapse