cyrilzakka/clinical-trials huggingface dataset:
Acupuncture in Osteoarthritis of the Knee

The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee

Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.

Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.

Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.

Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.

Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Eligibility Criteria:
Inclusion Criteria:

* Patients above age 35
* knee osteoarthritis grade II or III according to the Kellgren classification.

Exclusion Criteria:

* orthopedic deformations of the knee,
* malignant disease
* auto-immune disorders
* surgery including arthroscopy during the past 12 months
* pain medication with steroids
* physical therapy or acupuncture within the last for weeks
* no or a pain medication in continuous dosage
INTERACTION, Monitoring of Stroke Patients in Hospital and Home Environment

Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 or above
* Previous Stroke in the personal history
* Able to walk 10 meters. A walking aid (unilateral or bilateral) is permitted
* Able to walk without special shoes
* Able to raise the arm against gravity
* Able to read and understand questionnaires and able to execute commands
* Able and willing to participate in the study
* Singed Informed Consent

Exclusion Criteria:

* Contraindications on ethical grounds (vulnerable persons)
* known or suspected non-compliance, drug or alcohol abuse,
* Severe aphasia
* Severe dementia
* Severe depression
* Relevant medical disease or increased risk of rehospitalization
* Severe sensory deficits
* Severe neglect
TEE/Angio Fusion Study

This is a pilot study of patients undergoing structural heart disease procedures that utilize TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center. Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software prototype. This protocol is primarily intended to ascertain the potential utility of the software prototype in the study population and to provide data and feedback to improve the workflow and algorithms of the prototype. As such, a primary outcome variable and statistical analysis plan have not been identified. However, procedural time, measures of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual valvular regurgitation or paravalvular regurgitation as applicable, and complications will be recorded.

This study is for patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance at the NYU Langone Medical Center. It will evaluate the utility and workflow of the transesophageal echocardiography/angiography (TEE/Angio) fusion software prototype to provide visualization of anatomic landmarks and guidance during structural heart disease procedures.

The purpose of this study is to evaluate software (TEE/Angio fusion) that merges images from two standard procedures (ultrasound and x-ray) used to look at the heart during a procedure for structural heart disease. Typically, these 2-dimensional images are viewed separately, requiring the operator to mentally merge the two images together while deciding if he/she is in the correct location for the treatment strategy. TEE/Angio fusion is designed to make a single 3-dimensional image of the heart in real-time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be more than 18 years of age
* Subjects must have a plan to undergo a transcatheter-based structural heart disease procedure that utilize TEE and fluoroscopic guidance

Exclusion Criteria:

* Subjects with a known contraindication for insertion of the TEE probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup)Subjects who have a known contraindication for insertion of the TEE probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup)
* Pregnant
* Participating in a competing study
* Unable or do not provide consent
Subcortical Arousal in Perceptual Awareness

The study is a multi-site study and will be conducted at up to 11 investigative sites in the United States. The study will investigate subcortical arousal circuits in visual perception using techniques with complementary strengths based on promising initial studies.

The study will investigate subcortical arousal circuits in visual perception using techniques with complementary strengths based on promising initial studies. This study is expected to shed important light on the precise relationship between transient increases in subcortical arousal and perceptual awareness, generalizable across the visual modality. This research will therefore provide important general potential benefits, including 1. Identification of subcortical arousal systems in perception, which can benefit treatment of many disorders where perceptual deficits are common, e.g. traumatic brain injury, Alzheimer's disease, stroke, developmental disorders, schizophrenia, epilepsy and others. 2. Understanding the role of specific subcortical arousal circuits in perception may help target improved treatments, including transient thalamic stimulation like that planned for the present investigations, or less invasive treatments (TMS, tDCS, designer drugs) to improve function of these circuits. 3. The planned no-report paradigms may detect perceptual awareness in severe brain damage and anesthesia, where people are unable to overtly respond.

The main hypotheses are that 1. the thalamic awareness potential (TAP) will be associated with visual perception independent of report, and 2. thalamic intralaminar stimulation at the time of stimulus presentation will augment the probability of perceptual awareness.

Eligibility Criteria:
The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 13 years and up (Aim 1):

Inclusion Criteria:

* normal vision with or without the use of corrective lenses
* normal hearing not needing an assistive hearing device

Exclusion Criteria:

* severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements)
* unable to perform the perception task due to cognitive impairment other than due to the participant's epilepsy. All participants must be capable of consenting for themselves.

The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 18 years and up (Aim 2):

Inclusion Criteria:

* normal vision with or without the use of corrective lenses
* normal hearing not needing an assistive hearing device
* a female subject must have a negative pregnancy test and if sexually active, must be using a reliable form of birth control for the duration of the trial, be surgically sterile, or be at least two years post-menopausal.

Exclusion Criteria:

* severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements)
* unable to perform the perception task due to cognitive impairment other than due to participant's epilepsy. All participants must be capable of consenting for themselves.
* pregnancy
The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria
* Active prescription for an oral triptan medication to abort acute migraines

Exclusion Criteria:

* Tetracycline group or other anti-inflammatory medication use in the preceding three months
* Pregnant
Implant Retained CAD-CAM Ceramic Crowns

Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician, considering the time efficiency (one appointment) and overall lower costs as no dental laboratory is involved. The hypotheses are that the biological (BOP, PD, PCR, implant bone level) and mechanical outcomes (fracture, loss of retention, wear) are equivalent to implant screw-retained Porcelain-Fused-to-Metal (PFM) crowns over a 5 year observation time.This RCT will provide key information as to the cost/benefit, suitability and/or limitations of these chair-side hybrid-abutment crowns in the posterior region.

This RCT involves the University of Geneva Dental School and four private practices for which the Geneva Hospital Ethic Committee's approval is required. Patients in need for replacement of single unit posterior teeth will be recruited at the Dental School as well as in the 5 private practices based on specific selection criteria. Patients will be randomly assigned to a restorative group using a computer-generated random number table for allocation.

The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1) Lithium-disilicate glass-ceramic (e.max CAD) (G1) and 2) feldspath-ceramic infiltrated by polymer (Enamic) (G2). The CAD-CAM crowns are adhesively cemented to titanium base abutments (Ti-base) and screw-retained to Titanium implants (Straumann Standard Plus) in the premolar (RN) and molar region (WN). Controls are screw-retained PFM crowns (G3). The number of crowns in each group is N=30 (15 molars and 15 premolars) which gives a total of 90 crowns for this study.

Participants are recalled after 1 week-10 days after crown insertion (baseline, T0) and then yearly during 5 years (T1-T5). Digital X-Rays are taken at T0, T1, T3 and T5 with repositionable individual resin bite registrations.

Eligibility Criteria:
Inclusion Criteria:

* Absence of relevant medical condition
* Need for a single crown on implant in the molar or premolar region with existing adjacent and antagonist teeth
* No active periodontal or pulpal diseases
* Teeth with good restorations
* Straumann regular (premolar) and wide neck (molar) implants, osseo-integrated for a minimum of 2 months and facial keratinized mucosa width of at least 2 mm
* Patient agrees to return for follow-up examinations during 5 years
* Patient agrees to immediately inform the operator in case of problem

Exclusion Criteria:

* evidence of bruxism
* 2 adjacent implants
* implants placed of-axis
Same Day Oral EC and Implant Initiation

This is a study for clients presenting for emergency contraception (EC). EC is used to prevent pregnancy after unprotected intercourse. Clients presenting for EC may be offered either the copper or hormonal IUD or oral EC. Current guidelines allow for same-day implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. This study will look at pregnancy rates and clients willingness to receive same-day implant + oral EC and same-day IUDs.

Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC.

Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 18-35 years
* Fluent in English and/or Spanish
* BMI \< 30 kg/m2
* No known contraindication to either the ENG contraceptive implant or oral LNG EC using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
* Negative urine pregnancy test
* Willing to abstain from further UPI in the 7 days following insertion
* Know the date of their last menstrual period
* Regular menstrual cycle (24-35 days)
* Be willing to comply with the study requirements
* Desiring to avoid pregnancy for at least 12 months

Exclusion Criteria:

* Current pregnancy or breastfeeding
* Previous use of oral EC in the current cycle
* Report of UPI beyond 5 days in current cycle
* Vaginal bleeding of unknown etiology
* Allergy to LNG or ENG, IUD or implant in-place
* History of permanent contraception through sterilization or hysterectomy
* Monogamous partner with a vasectomy
* Depo-provera injection within past 15 weeks
A Low Glycemic Index Diet as Prevention of the Catch-up Fat Phenomenon

The catch-up fat phenomenon is an evolutionary conserved physiological response to a starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis, reduced body protein regain and an increase in fat mass above basal level during refeeding. Clinically, it characterises weight cycling in overweight patients which is associated with increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance, inflammation). In this project, the physiological, cellular and molecular mechanisms of this phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat phenomenon and its sequelae. This translational research will provide comprehensive insights into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.

In a human intervention study, changes in physiological, metabolic, and neuroendocrine functions in response to weight cycling will be investigated under controlled conditions in normal weight subjects. The mechanisms of the catch-up fat phenomenon are analysed starting from stable energy balance followed by overfeeding, weight loss and weight regain following weight loss (refeeding). Changes in body composition (including ectopic fat), metabolism (resting energy expenditure, substrate oxidation rates, insulin resistance) and plasma hormone concentrations will be assessed. Fat tissue probes will be used to characterise key enzymes and signalling pathways, redox status and whole genome expression. Modulation of the hormonal response to weight cycling is brought about by varying macronutrient content and glycemic index of the diets. We hypothesize that, insulin and leptin resistance are explained by increased insulin secretion during the refeeding period. Both, adaptive thermogenesis as well as insulin and leptin resistance can be ameliorated by attenuation of the increase in insulin and leptin secretion during refeeding a low GI diet after weight loss.

Eligibility Criteria:
Inclusion Criteria:

* normal weight (BMI 20-24 kg/m2), normal fat mass

Exclusion Criteria:

* smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants
Theory-Based Obesity Intervention Program for Women

The aim of this study is to examine the effect of education and counseling given to women according to the Theory of Planned Behavior on weight management. This study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. A total of 78 overweight and obese women included in the study. The participants assigned to either of the groups by the block randomization method. A training program consisting of a total of five sessions applied to the intervention group, and counseling will be provided for 6 months. The data will be analyzed with Statistical Package for Social Sciences (SPSS) 22.0 package program.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being a woman in the age group of 18-49 years
* Having a body mass index (BMI) of 25.0-30.0 kg/m2 (overweight) or \>30.0 kg/m2 (obese)
* Not going through menopause
* Not having diabetes
* Not having thyroid disease
* Not using hormonal contraceptive pills
* Not having polycystic ovarian disease
* Not having a metabolic disease
* Not having Cushing's syndrome
* Not having a disease that prevents physical activity
* Not having hypertension
* Not being pregnant or breastfeeding
* Owning and using a smart phone
* Having a mail account in Google and being able to use it

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Not volunteering to participate in the study
* Women with communication problems
* Women who did not give consent at any stage of the study and who quit the study
RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

Coronary heart disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular events (MACE).

At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Foreign studies indicate that hsCRP ≥ 2mg / L is the definition standard of RIR in CAD. In China, there is no defined value of RIR for patients undergoing PCI, and the incidence of RIR has not been investigated clearly. At the same time, the impact of dynamic changes of hsCRP on MACE in PCI population needs to be further explored. Therefore, in this study, we plan to recruit patients undergoing PCI, and observe the impact of RIR by serial hsCRP measurements on the prognosis of these patients followed up for 5 years.

Serial hsCRP measurements with ≥ 4 weeks between both measurements are defined in this analysis. Time-to-event is measured from first hsCRP measurement.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who understand and sign the informed consent form voluntarily;
2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
3. The hospitalized patients with coronary heart disease undergoing PCI;
4. Complete all planned PCI during hospitalization

Exclusion Criteria:

1. Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease;
2. Uncontrolled infectious diseases during the screening period;
3. In the screening stage, patients with immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on;
4. Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period;
5. Surgical or interventional treatment was performed within 3 months before the screening period;
6. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
7. Participated in other clinical trials within 3 months before the screening period;
8. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium

The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.


Eligibility Criteria:
Inclusion Criteria:

1. A condition of general good health
2. BMI 19 to 29

Exclusion Criteria:

1. Currently enrolled in another clinical study
2. Females who are pregnant or breast-feeding
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer

This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.


Eligibility Criteria:
Inclusion Criteria:

1. cervical cytologic test result is HSIL
2. persistent infection with high-risk HPV
3. cervical pathological diagnosis is LSIL or HSIL

Exclusion Criteria:

1. acute infection of lower genital tract
2. the wound in lower genital tract
3. active bleeding in lower genital tract
Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* ≥ 18 years old
* Understanding of the German language (written and oral)
* Single and multiple finger injuries
* Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
* Treated by the hand surgery department at the Inselspital Bern
* Treated with at least a 4-strand core suture

Exclusion Criteria:

* \< 18 years old
* Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
* Replantation of the injured finger
* Fracture of the injured finger
* Primary tendon reconstructions