cyrilzakka/clinical-trials huggingface dataset:
The Effect of Obesity on Lung Functioning

This research study is looking at the effects of weight loss, due to surgery or structured weight-loss program on lung function, inflammation in your body and lungs, asthma and asthma symptoms. This study is important because we will be better able to understand the effect of weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling in this study at National Jewish.

Adults with asthma who has elected to undergo weight-reduction surgery may qualify for the participation. Involvement will last about 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18yr) who report a physician's diagnosis of asthma and have taken any asthma medication within the last 2 weeks.
* Obesity (Body Mass Index (BMI) ≥40, or ≥35 with comorbidities, as per published guidelines for qualification for bariatric surgery).
* Planned weight-loss surgery or structured weight-loss plan.

Exclusion Criteria:

* Tobacco use within one month.
* Qualifying lung-functioning.
* Qualifying oxygen saturation levels.
* Use of systemic corticosteroids (Prednisone) within one month.
* Presence of another chronic lung disease besides asthma (COPD, bronchiectasis, ILD, sarcoidosis, etc).
* Presence of another chronic systemic inflammatory disease (rheumatoid arthritis or other connective-tissue disease, chronic infection such as osteomyelitis, inflammatory bowel disease, chronic active hepatitis, etc). Subjects with osteoarthritis, stable coronary artery disease, hypertension, or diabetes mellitus will not be excluded.
* Presence of malignant neoplasm within the last 3 years (with the exception of non-melanoma skin cancer).
* Clinically significant left or right ventricular dysfunction.
* Severe pulmonary hypertension (high blood pressure).
* Untreated obstructive sleep apnea:
* Subjects with a current diagnosis of sleep apnea not being treated with CPAP or BiPAP will be excluded.
* Subjects with a current diagnosis of sleep apnea being treated adequately (as determined by the investigators) will be included.
* Prader-Willi syndrome
* A known endocrinopathy causing obesity (e.g., Cushing's Syndrome).
Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* age 50-85 years old
* ASA class 1-3

Exclusion Criteria:

* unable to perform spinal anaesthesia
* history of coagulation disorder
* renal impairment (CrCl \<30 mL/min) or cirrhosis
* platelet count \< 100,000 or abnormal coagulogram
* on pacemaker
* stop anti-platelet or anti-coagulogram less than 7 days
Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

The purpose of this pilot study is to determine whether a program involving both in-lab and at-home training using cranial nerve stimulation (CN-NINM) delivered via the tongue can reduce symptoms of multiple sclerosis (MS) and improve movement control and therefore provide ground work for a controlled clinical trial. The effects of the stimulation will be measured using a variety of standardized tests of movement control and cognitive function, functional brain imaging, and MS-specific surveys of your quality of life.

Fourteen MS patients, seven each in an active and a sham stimulation group are expected to participate.

Participants will receive intensive physical therapy and working memory training for 14 weeks.

Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks will be completed prior to and following therapy, as will be sensory organization tests (SOT), motor performance measures, and neuropsychological assessment.

Prior to the start of CN-NINM training, each participant will undergo baseline evaluations including structural and fMRI, balance tests (SOT), Dynamic Gait Index (DGI), neuropsychological assessment (Handedness; Wechsler Abbreviated Scale of Intelligence (WASI) Vocabulary and Matrix Reasoning; California Verbal Learning Test (CVLT)-11; D-Kefs Trails, Color/Word and Verbal Fluency; Tower of London Second Edition; Ruff 2 and 7; Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Letter-Number sequencing, Coding and Symbol Search; Paced Auditory Serial Addition Test (PASAT); Leonard Tapping; and Grooved Pegboard). In addition, the MS Impairment Scale, Fatigue Impact Scale, Cognitive Function Inventory for MS, and Beck Depression and Anxiety questionnaires will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing/remitting or secondary progressive MS with balance and gait problems;
* Recent EDSS score of 3.0 - 6.0;
* Provided informed consent and willing to participate

Exclusion Criteria:

* Use of tobacco products;
* Oral health problems including abrasions, cuts, cold sores, piercings, or tissue inflammation in the oral cavity;
* Baseline EDSS \>6.
Reducing Fasting Time in Children for Sedation

Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients.

This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged under 36 months
* scheduled for elective cardiac echocardiography

Exclusion Criteria:

* patients with disease that delay gastric emptying
* patients taking medication that delay gastric emptying
* structural deformities, or abnormalities that interrupt gastric ultrasound
* refuse to participate in the study
* sedation is failed or impossible
Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia

Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia.

Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia.

Methods We recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern Taiwan. Participants were assigned by blocked randomization into experimental group and control group. Those in the experimental group received 60 minutes, three times a week for 12 weeks of Baduanjin program training, while those in the control group received physical activity for thirty minutes. We collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. Chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. Demographic variables were controlled. Generalized Estimating Equations (GEE) were used to examine the effects of groups, time, group and time interaction by sex.

This study explored the effect of Baduanjin on metabolic parameters and body mass index in people with schizophrenia. We recruited 92 participants from 3 rehabilitation units in Taiwan. Participants were assigned by blocked randomization into an experimental group or control group. Those in the experimental group received 60 minutes of Baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. We assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of schizophrenia
2. between 20-65 years of age
3. BMI ≥ 24 kg/m2 or at least one metabolic parameter abnormality
4. ability to listen, speak and write Chinese
5. no additional exercise beyond normal exercise.

Exclusion Criteria:

1. patients in acute phase requiring hospitalization;
2. patients with severe and unstable
Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine. This is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. The goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to document their pain score days 1 and 2 post op. They will also be asked to keep a medication log for 14 days post op.

Subjects will have a through physical exam with evolution of the pelvis support using the POP-Q (pelvic organ prolapse quantification) system. All subjects will need to sign informed consent pre-approved by the IRB. The subjects, surgeons, and anesthesiologist will all be blinded to the injected material. The OR Scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. All subjects will receive general anesthesia. Subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine or normal saline to each side. The allocation schedule is computer generated using random-numbers table concealed in opaque envelops. Once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded Allan stir ups. 10 ml of Bupivacaine will be injected on either side using the Iowa trumpet pudendal needle drive to direct and guide appropriate position. Aspiration was attempted for every injection to decrease the chance of intravascular infusion.

At the completion of the surgery the subjects will be brought to the PACU for care. Patients are assessed immediately upon arrival to the PACU. The patients are asked their pain level using the VAS pain scale/ modified surgical pain scale at hours 1 and 2 post op. All patients are given a prescription for Vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. Patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. Continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. A medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.

Eligibility Criteria:
Inclusion Criteria:

* The ability to read and understand English
* Be at least 18 years old
* Symptomatic Stage 2 prolapse

Exclusion Criteria:

* Intolerance to local anesthetics or narcotics
* History of major psychiatric disorder or chronic pain syndrome
* History of substance abuse or current narcotic use
Reduction Mammaplasty and Improved Quality of Life

The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.

Eligibility Criteria:
Inclusion Criteria:

* above 18 years
* macromastia on clinical examination
* fulfilled Breast Q Questionnaire prior to surgery and after surgery
* signed informed consent

Exclusion Criteria:

* failed to sign informed consent
* failed to fill the Breast Q Questionnaire
* patients with altered mental status and behaviour
* patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer
Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).

The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.


Eligibility Criteria:
Inclusion Criteria:

* Participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, or Sweden within the observation period of 1995 to 2013
* Male with breast cancer with medical information in one of the 4 country-specific registries in this study OR country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries
* Study participant's exposure to finasteride is available

Exclusion Criteria:

For country- and age-matched control men without breast cancer

* Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer
* Previous prostatectomy
* Finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design).
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Eligibility Criteria:
Inclusion Criteria:

1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
3. DEU is being cared for in a home environment and most of the care is provided by a main CGR.
4. DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person.
5. CGR is willing and able to provide informed consent to participate in the clinical investigation.
6. The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
7. If incontinence is managed by pharmaceuticals, the dose regime is stable.
8. DEU and CGR ≥ 18 years of age.

Exclusion Criteria:

1. DEU is cared for in a professional establishment or is institutionalized.
2. DEU has ≥ 4 fecal "incidences" per week.
3. DEU has severe incontinence product related skin problems, as judged by the investigator.
4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
7. CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.
8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
9. DEU is pregnant or nursing.
10. CGR or DEU with an alcohol or drug addiction
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. The target population is people with locked-in syndrome. For these patients there is no technique available to allow them to communicate unaided. We have developed a brain-computer interface (BCI) system that can read activity directly from the brain, and can convert the activity to a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. A dedicated computer will convert the signals to electrical pulses for standard Assistive Technology devices. The UNP can in principle enable the patient to engage in any activity that is offered by commercial Assistive Technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. Most importantly, we aim to achieve unsupervised function of the BCI, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75
* Locked-in status (i.e. severely paralyzed with communication problems)

  * in case of trauma or stroke: at least 1 year after the event
  * in case of a neuromuscular disease: slow progression allowed
* Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech)
* Mentally and physically capable of giving informed consent
* Lives in or close to the Netherlands
* MR compatible

  * able to lie flat in the scanner
  * no metal objects in or attached to the body
  * no claustrophobia
* Visus (largely) intact
* Cognition intact (IQ\>80)
* Compatible with implantation procedure

  * good respiratory function or stable respiratory situation using ventilation assistance

Exclusion Criteria:

* Strong and frequent spasms
* Vital indication for blood thinners
* Current brain tumor or history of tumor resection
* Quick medical or neurological deterioration
* Patients who are considered legally incapable (and who therefore will not be able to give informed consent)
* Current or recent psychiatric disorder
* Catabolic state
* Allergy to the materials of the implant
TSH Receptor Mutations Among a Consanguineous Community

Resistance to thyrotropin (RTSH) is a condition of impaired responsiveness of the thyroid gland to TSH, characterized by elevated TSH, low or normal thyroid hormone levels, and hypoplastic or normal-sized thyroid gland.

The aim of the present study was to evaluate the clinical course over time,the genotype-phenotype association and the frequency of two different TSH-receptor (TSHR) mutations in a highly consanguineous population of the town of Um-El-Fahem.

Resistance to thyrotropin (RTSH) is a syndrome involving reduced sensitivity to TSH. It is characterized by elevated TSH, absence of goiter (normal or hypoplastic thyroid gland) and normal to very low levels of thyroid hormones. The TSH-receptor (TSHR) gene is located on chromosome 14q31 and it consists of extracellular, trans-membrane and intracellular domains. Mutation in the TSHR may cause either gain or loss of function of the receptor. Loss-of-function mutations are autosomal-recessively inherited and lead to a spectrum of phenotypes, ranging from mild euthyroid hyperthyrotropinemia to severe congenital hypothyroidism (CH). Insensitivity to TSH depends on both the severity and location of the TSHR mutations. Since the first report of familial euthyroid hyperthyrotropinemia caused by a TSHR mutation, several cases of loss-of-function mutations of the TSHR have been reported however only a few reports on the outcome of patients affected with TSHR mutations. Whether the condition of euthyroid hyperthyrotropinemia leads to clinical hypothyroidism, remains stable or normalizes over time has yet to be elucidated. We recently described a unique novel TSHR-inactivating mutation located at the third extracellular loop that preferentially affected the inositol phosphate (IP) pathway in three sisters of Arab-Muslim decent that presented with euthyroid hyperthyrotropinemia. Further analysis of the extended family revealed additional members with TSHR syndrome phenotype carrying two different TSHR mutations. All the affected subjects live in the same town. The aim of the present study was to evaluate the clinical course over time, the genotype-phenotype association and the frequency of these two different TSHR mutations among the highly consanguineous population of the town of Um El Fahem.

Eligibility Criteria:
Inclusion Criteria:

* Subjects belonging to extended family of the index case

Exclusion Criteria: