cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Cervical Medial Branch Blocks

In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.

While several clinical trials have found that ultrasound guidance provides similar accuracy to fluoroscopy and reduces performance times for cervical medial branch blocks, larger studies documenting safety-related outcomes are lacking. In addition, although cervical medial branch blocks are an accepted tool to diagnose neck pain originating from the cervical facets, there are reports of long-lasting analgesic effects in a subset of patients, suggesting that these blocks may have long-term benefits. We therefore propose to prospectively examine the incidence of adverse events, as well as the clinical long-term effects of ultrasound-guided cervical medial branch blocks, in a cohort of pain clinic patients undergoing these procedures as part of their usual care.

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients over 18 years of age undergoing cervical medial branch blocks as part of their usual care and who have a pain intensity of at least 5/10 (at rest or on movement) and a pain duration of at least 4 months.

Exclusion Criteria:

* Inability to communicate or complete follow up questionnaires
* Known bleeding disorder or coagulopathy
* Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents)
* Inability to visualize targeted structures on ultrasound
* Presence of acute radiculopathy of new onset neurological symptoms in the upper extremities
* Patients with bilateral neck pain if only one side is treated
Influence of Flap Position Following FibReORS

There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. The placement of the flap 2 mm apically to the bone crest instead at the bone level would be a viable approach to increase KT width without delaying wound healing. The extent of post-operative discomfort/pain was not influenced by primary flap position.


Eligibility Criteria:
Inclusion Criteria:

1) diagnosis of severe chronic periodontitis (corresponding to grade III or IV according to the actual classification); 2) good general health; 3) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 20%; 4) at least two contralateral sextants with residual PDs of \> 5 mm and persisting bleeding on probing (BoP) at posterior natural teeth 3 months after the completion of cause-related therapy

Exclusion Criteria:

1) pregnancy and lactation; 2) smoking \> 10 cigarettes/day; 3) intake of antibiotics in the previous 6 months. In addition, teeth with degree II or III mobility, horizontal bone loss higher than 1/3 of the root length or designed as abutment for prosthetic rehabilitation were also excluded from the study.
Regional Adipose Tissue Characteristics in Type II Diabetes

Fat tissue in different parts of the body has different characteristics. Several studies have associated abdominal fat to an increased risk for multiple metabolic diseases, such as type 2 diabetes and cardiovascular disease, compared with fat located under the skin at the hips and thighs. However, the investigators do not know how the abdominal fat causes or contributes to the development of these diseases or how the development of these disease may in turn cause or contribute to changes in the fat tissue. The general objective of this study is to understand these mechanisms.

To investigate these questions, the study will recruit 140 participants, both men and women aged 18-65 years. The participants will be divided into three groups: 40 people with obesity, 40 with diabetes, and 60 lean individuals. Participants will be recruited from patients at the CIUSSS du Nord-de-l'Île-de Montréal - Hôpital du Sacré-Coeur de Montréal who are awaiting bariatric or general abdominal surgery, as well as from the general population in the Montreal area.


Eligibility Criteria:
Inclusion Criteria:

* Men, premenopausal and postmenopausal females between 18-65 years
* Anticipating having bariatric surgery (participants with obesity) or general surgery in the abdominal area (normal weight participants) with a duration of less than 1.5 hours.
* BMI 30 kg / m2 (participants with obesity)
* Weight Stable for a minimum of two months prior to the first pre-op visit

Exclusion Criteria:

* Smoking
* Renal impairment defined by creatinine clearance; 60 ml/minute
* Uncontrolled hypothyroidism
* No comorbidity other than diabetes type II Exceptions: controlled hypertension, hypothyroidism controlled, controlled dyslipidemia
* Use prescribed medication that affect our outcomes E.g. Exceptions include metformin, DPP-4 inhibitors, inhibitors of the α-glucosidase, hypotensive with a stable dose for 3 months lipid lowering with a stable dose for 3 months.
Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Visual impairment predominantly due to DME.

Exclusion Criteria:

* Stroke or myocardial infarction less than 3 months prior to screening.
* Presence of uncontrolled systolic blood pressure or diastolic blood pressure
* Renal failure requiring dialysis or renal transplant or renal insufficiency
* Untreated diabetes mellitus
* Use of any systemic anti-VEGF drugs
* Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
* Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception

For either eye:

* Any active periocular or ocular infection or inflammation
* Uncontrolled glaucoma
* Neovascularization of the iris or neovascular glaucoma
* History of treatment with any anti-angiogenic drugs

For study eye:

* Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
* Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization or macular edema of any other cause than DME
* Irreversible structural damage within 0.5 disc diameter of the center of the macula
* Panretinal laser photocoagulation within 6 months prior to randomization.
* Focal/grid laser photocoagulation within 3 months prior to randomization.
* Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following
* Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
* Application of intravitreal corticosteroids in vitreous within 6 months prior to screening. Prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening.

For fellow eye

- Retinal or choroidal neovascularization or macula edema of any cause

Other protocol-defined inclusion/exclusion criteria may apply.
Registry of Patients With Takotsubo Syndrome

Takotsubo syndrome is a condition which mimics acute myocardial infarction, and is diagnosed in 1.5% to 2.2% of patients referred to hospital with suspected acute coronary syndrome. It is also known as broken heart syndrome, takotsubo cardiomyopathy, stress cardiomyopathy and apical ballooning cardiomyopathy, among other names. The pathogenesis of this disorder is not well understood. Possible mechanisms include catecholamine excess, coronary artery spasm, microvascular dysfunction, among others. This is a multicenter, nation-wide, observational study of patients who were previously diagnosed with takotsubo syndrome. The investigators aim to use this registry to help plan and carry out further studies and to improve understanding of the pathophysiologic mechanisms of this syndrome. In addition participants will be followed for events, and to monitor quality of life and stress.

Patients are eligible to participate if they are aged 18 years or older and carry a physician confirmed diagnosis of takotsubo syndrome. Patients with a history of takotsubo syndrome will be identified via physician referral, Epic search and patient self-referral. Patients may register directly through our registry website at www.nyulmc.org/brokenheartstudy or via direct contact with the study team via e-mail or telephone. Following completion of a research authorization form and collection of medical records, study team will confirm the diagnosis of takotsubo syndrome. Data will be collected including contact information, medical history, data on the takotsubo event(s) including physician records and all relevant imaging. Participants will also be asked quality of life questionnaires and will be followed every 4 months for events.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of takotsubo syndrome
* Age\>18 years

Exclusion Criteria:

- Lack of capacity to provide informed consent
Randomized Trial of Tapas Acupressure for Weight Loss Maintenance

This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique) compared to a Social Support (SS) group for the primary outcome of weight loss maintenance. We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who meet eligibility criteria are entered into an intensive six-month weekly group-based behavioral weight loss program. Those who meet threshold weight loss criteria (n=\~288) are randomly assigned to either TAT instruction or social support group. Participants in both groups attend the same schedule of group meetings with parallel contact hours. Participants in the TAT group are advised to practice the technique at home. Participants are weighed and questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The main outcome measure is weight at 18 months.


Eligibility Criteria:
* Inclusion criteria for the Phase I weight loss program:

  * Men and women
  * At least 30 years of age
  * BMI 30-50 kg/m2 (inclusive)
  * Weight \<400 lbs
  * Reside in Portland metropolitan area including Vancouver/Clark County, Washington
  * Willing and able to participate in all aspects of the intervention
  * Willing to attend the group-based weight loss program for 6 months
  * Willing to follow a reduced calorie healthy dietary pattern
  * Willing to exercise on a regular basis
  * Willing to lose 10 pounds during the 6-month weight loss program
  * Willing to accept random assignment to one of the two maintenance interventions
  * Willing to provide informed consent

Exclusion criteria for the Phase I weight loss program

* Medical conditions or treatments that would be contraindicated using a diet and exercise weight loss treatment
* Treatment for cancer (except for non-melanoma skin cancer) currently or in the past 2 years
* Diabetes treated with insulin; does not exclude diet-controlled, controlled with sulfonylurea (glyburide, glipizide, etc.) with primary physician's approval, or controlled with other oral agents (metformin, precose, glitazone.)
* Psychiatric hospitalization in past 2 years
* Conditions that require limitation of physical activity
* Congestive heart failure
* Cardiovascular disease (stroke, MI, CABG, angioplasty/stent) in the past 2 years
* Taking weight loss medications currently or within past 6 months
* Any history of weight loss surgery or scheduled surgery for weight loss.
* Liposuction in the past 12 months
* Prior acupuncture or acupressure treatments for weight loss
* Planning to leave the area prior to the end of the program
* Body weight change \> 20 pounds in the past 6 months
* Pregnant, breast feeding, or planning pregnancy prior to the end of participation
* Current participation in another clinical trial
* Investigator discretion for safety or adherence reasons
* Household member (living at the same address) of another participant in this study
* LIFE clinical trial staff member or family member of LIFE trial staff person
A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative);
2. Aged 18\~80, regardless of gender;
3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
4. NIHSS ≥ 10 points at screening;
5. A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
6. The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion Criteria:

1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia;
2. CT/MRI suggested that the anterior septal/pineal excursion was \>2 mm due to brain edema;
3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);
Effects of Chest Physiotherapy and Lungs Squeezing Technique in Patients With Chronic Obstructive Pulmonary Disease.

Chronic pulmonary obstructive disease refers to a group of lungs problems that includes blockage of airway and difficulty in breathing. It includes mostly emphysema, asthma and chronic bronchitis. Chronic pulmonary obstructive disease is the third main cause of death in the whole world .The diagnosis of chronic obstructive pulmonary disease can be made by spirometer and the ratio of forced expiratory volume in 1 second over forced vital capacity (FEV1/FVC) should be less than 70%. It shows severity of airway obstruction .First technique is Chest physiotherapy, in which slow and gentle cupped hand slaps are given on effected lobe of lungs while second technique is lungs squeezing technique, in which 3-4 chest compressions are applied on the chest wall.

The study design of this study will be randomized clinical trial. In this study non probability convenience sampling technique will be used to collect the data. Data management and analysis will be done by using SPSS 25. This randomized clinical trial will include 48 patients with chronic obstructive pulmonary disease. Their ages will be ranged from 40 to 60 years old male with the chronic obstructive pulmonary disease diagnosed with GOLD guidelines stage II moderate to severe .The participants will be randomly allocated into two equal groups, the Group I will receive Chest physiotherapy, while the Group II will receive lungs squeezing technique for 20 minutes duration per session, three sessions per week, for a period of 4 weeks. The status of airway clearance, oxygen saturation and lungs volumes will be measured pre and post intervention in each training session.


Eligibility Criteria:
Inclusion Criteria:

* Age 40_60 yrs. old male
* COPD diagnosed with GOLD guidelines stage 2 moderate to severe(14)
* FEV1/ FVC ratio below 70%
* No use of beta 2 receptor agonist or anticholinergic drugs at least 6 hours before attending the study

Exclusion Criteria:

* unstable cardiovascular diseases
* SpO2 at rest below 88%
* Active pulmonary Tuberculosis
* Neurological disorders
"Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"

The first major intervention a newborn infant is facing following birth is clamping of the umbilical cord. This means separation of the infant from the placenta, the newborn becomes an independent individual, especially from a cardio-circulatory perspective. There is still a lack of understanding of the issues associated with umbilical cord clamping. The aim of the present study is to investigate whether cord clamping after onset of sufficient spontenous breathing is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.

Recent literature focused very much on the appropriate timing of the cord clamping (CC), distinguishing immediate cord clamping (ICC) from delayed cord clamping (DCC). Although potential benefits for DCC have been documented, especially for preterm infants, ICC still is the most widely used procedure. Although the reasons for this are unclear, a lack of understanding of the issues associated with umbilical cord clamping is thought to be a major underlying factor.

In animal research with fetal lambs it has been shown, that aeration of the lung played a crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung was established, calling this "Physiological-Based Cord Clamping" (PBCC). It was shown, that PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral oxygenation was measured using near infrared spectroscopy (NIRS).

Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.

Eligibility Criteria:
Inclusion Criteria:

* Vaginally born and term infants
* undisturbed transition period

Exclusion Criteria:

* congenital malformations
* respiratory support during transition period
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers

The human Prion diseases can be classified into sporadic, acquired and inherited forms. Inherited forms usually manifest in higher age so there have to be factors preventing Prion propagation in young mutation carriers. Antibodies against the flexible tail of Prions have been shown to be protective in mice. The investigators intend to screen mutation carriers and controls for the presence of Prion autoantibodies.


Eligibility Criteria:
Inclusion Criteria:

* Relatives of patients of genetic Prion diseases
* Obtained informed consent

Exclusion Criteria:

* No informed consent
Perioperative Longitudinal Study of Complications and Long-term Outcomes

Purpose: with an increased risk of complications. Improved preoperative risk stratification and earlier diagnosis of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) aims to establish a comprehensive biorepository that will facilitate research in this field.

Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first 7 postoperative days (or longer as indicated), participants will be subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel EEG). In addition, we will collect blood samples as well as microbiome specimens at selected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium. Secondary outcomes include mortality as well as long-term psychopathology, cognitive dysfunction, and quality of life.

PLUTO is the first perioperative biobank worldwide that includes a broad range of high-risk surgical patients, collecting prospective bedside data as well as both blood and microbiome specimens during the entire perioperative period. The data and materials collected in PLUTO will be used to develop, externally validate, and update prognostic prediction models for improved risk assessment, to test novel biomarkers for early detection of postoperative complications and to study the aetiology, attributable morbidity and mortality related to these events.


Eligibility Criteria:
Inclusion Criteria:

- Undergoing an elective, high-risk gastro-intestinal or vascular procedure, or intermediate risk procedure (including gynaecological, orthopaedic and head and neck surgery) if the procedure includes a laparotomy and/or is associated with a scheduled hospital length of stay ≥ 5 days.

Exclusion Criteria:

* \< 18 years of age
* Emergency surgery
* Severe anaemia (Hb \< 4.5 mmol/L)
* Unable to provide informed consent
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 21 and 75 years of age
* Body mass index (BMI) ≤ 32 kg/m2
* Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
* Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.

Exclusion Criteria:

* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires