cyrilzakka/clinical-trials huggingface dataset:
Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.

In this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery.

Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities.

Functional abilities will be examined using two validated questionnaires:

1. The Western Ontario Shoulder Instability index (WOSI)
2. Disabilities of the Arm, Shoulder and Hand (DASH)

Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)

Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system, model 4.

Eligibility Criteria:
Inclusion Criteria:

* 26-28 weeks s/p surgical repair of shoulder instability
* At least 1 shoulder dislocation prior to surgery

Exclusion Criteria:

* Previous surgery in either shoulders
* Any injury in the non-operated shoulder in the last 6 months
* Any history of shoulder dislocation or subluxation in the non-operated shoulder
* Any tendon repair during the surgery.
Trimodal Prehabilitation in Patients Undergoing Elective Surgery

Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation

Patients with high surgical risk will participate in 4 week prehabilitation that will consist of 4 stationary sessions - one per week - comprised of: physiotherapy session, psychological session and nutritional advice. During first session each patient will receive an activity monitor and dedicated mobile app that will record his daily performance.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
* Unfit patients

Exclusion Criteria:

* physical condition that makes the patient is not able to perform rehabilitation exercises
* cardiac and respiratory instability or high risk of its occurrence
* inability to use electronic devices used in the study
Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.

Pembrolizumab is a humanized antibody used in cancer immunotherapy.The NMPA(China) approved pembrolizumab for first-line treatment of certain patients with advanced NSCLC.

This is a multi-center non-interventional study, advanced NSCLC patients who treated with pembrolizumab and provide written informed consent will be included. The main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
2. Patients who receive pembrolizumab for advanced NSCLC.
3. Patients who provided written informed consent.

Exclusion Criteria:

1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Pharmaceutical Care of Ambulatory Elderly Diabetes Patients

This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients. To provide appropriate diabetes education administration, identify and resolve drug-related problems, assess the appropriateness of their medications, establish the mechanism of medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's intervention will be assessed by lab data and some questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* A1c greater than or equal to 9.0

Exclusion Criteria:

* Not expected to live for the duration of the study
* Unwillingness to participate and attend pharmacist visits
* Unwillingness to participate the questionnaires(MMSE, GDS)
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline.

Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.

Patients with HER2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included.

Blood samples will be collected at baseline (before neoadjuvant start) for the analysis of CTCs and its positivity for HER2 by IHC and ISH.

Patients with pathological complete response will be included in the randomization phase of the study. There will be 2 cohorts: HER2 positive CTCs at baseline and HER2 negative/absent CTCs at baseline. In each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab

Eligibility Criteria:
Inclusion Criteria:

* HER2 positive breast cancer (hormone receptors positive or negative)
* Stage I to III
* Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
* Breast surgery after neoadjuvant therapy
* Preserved coagnition
* ECOG 0-3
* For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)
* Agreement on participation and signature of de ICF

Exclusion Criteria:

* Contradindication for trastuzumab or pertuzumab
* Adjuvant chemotherapy. Hormone therapy is allowed
* Second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer
Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

Active metropolitan area surveillance for hospital admissions related to invasive infection with Neisseria meningitidis will be conducted at the 12 centers in the IMPACT network in collaboration with Public Health officials, local infection specialists and infection control practitioners during the interval from January 1, 2016 to December 31, 2022.

The objectives are 3-fold, including:

1. description of affected children and adults and the nature and outcome of the infection episodes
2. incidence rate determination in defined populations, by age, serogroup and study year
3. detailed study of the organisms recovered from cases

Eligibility Criteria:
Inclusion Criteria:Neisseria meningitidis isolated or detected by PCR from a normally sterile body site or fluid, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy -

Exclusion Criteria:patients diagnosed based only on

1. clinical signs, gram stain, or antigen test
2. meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -
Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)

Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.


Eligibility Criteria:
Inclusion Criteria:

* i)Aging between 18 and 75 years, able to read and write Chinese;
* ii)have a TCM diagnosis of spleen deficiency and qi stagnation pattern;
* iii) Having normal esophagogastroduodenoscopy results within 6 months;
* iv) Having normal liver and renal function confirmed by blood tests within 3 months;
* v) Being diagnosed as PDS of FD by a specialist consultation;
* vi）Receiving no other treatments during the study;
* vii）Voluntarily agreeing with the study protocol and signing a written informed consent.

Exclusion Criteria:

* i)Having peptic ulcer or gastroesophageal reflux disease confirmed by esophagogastroduodenoscopy;
* ii) Having obvious signs of irritable bowel syndrome;
* iii) Having alarm symptoms (weight loss, black or tar stool, or dysphagia);
* iv) Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness;
* v) Having had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago;
* vi) Pregnant or breastfeeding;
* vii) Being taking drugs which may affect the gastrointestinal tract; a minimum wash-out period of two weeks is required before participating in the trial;
* viii) Having a problem of malabsorption or maldigestion;
* ix) Having a history of allergies to the studied drugs and food;
* x) Having difficulties in attending the trial (such as paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy);
* xi) Unwilling to sign the informed consent.
Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer

This study attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.

PRIMARY OBJECTIVES:

I. Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation.

II. Find the relationship between fNIRS (functional near-infrared spectroscopy) features and severity of pain as well as the relationship (if any) between perceived pain severity and visual perception.

SECONDARY OBJECTIVES:

I. Investigate the effect (and the reasoning of the effect) of alleviating severity of perceived pain utilizing virtual reality techniques.

II. Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques and/or cognitive distraction.

OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B or group C.

GROUP A: Participants undergo fNIRS for over 15 minutes.

GROUP B: Patients undergo fNIRS for over 15 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes.

GROUP C: Patients undergo fNIRS for over 15 minutes.

GROUP D: Patients are randomized to 1 of 2 arm:

ARM I - Patients undergo fNIRS for over 15 minutes followed by a relaxation period using VR for over 15 minutes.

ARM II: Patients undergo fNIRS for over 15 minutes

Eligibility Criteria:
Inclusion Criteria:

* Study participants (cancer patients as well as healthy volunteers) must be over the age of 18
* Study participants (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
* For cancer participants: in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing acute pain from treatment. Cancers include but are not limited to: breast, thoracic, kidney, etc.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements
* Currently pregnant or planning to become pregnant during the study period
* Medical condition predisposing to nausea or dizziness.
* Hypersensitivity to flashing light or motion.
* No stereoscopic vision or severe hearing impairment.
* Unwillingness or inability to follow protocol requirements.
* Individuals with impaired decision-making capacity.
* Individuals with electronic or metallic implants in the head.
* Unable to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs
Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)

The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) \[Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)\] at 6 weeks post implantation.

Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
3. Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
4. Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
5. Target lesion ≤28 mm in length by visual estimate
6. Agree to participate and provide informed consent

Exclusion Criteria:

1.Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)
To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population

Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.

To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between \> 20 and \< 50 years of age
* BMI of \>18 and \< 23 kg/m2
* Fasting blood glucose value of volunteer is \> 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening

Exclusion Criteria:

* Chronic smokers, tobacco chewers and drinkers.
Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release

The Purpose of this study is to report a new single portal endoscopic release technique and the sequence of the first 50 patients who underwent this release.

This will be a chart review of the demographics, outcomes, and complications of a sequential series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).


Eligibility Criteria:
Inclusion Criteria:

* This will be a chart review of the first 50 patients who have had surgery using the single portal technique
An Observational Pilot Study of the Effects of Traumatic Haemorrhagic Shock and Resuscitation on the Microcirculation

Haemorrhage following major trauma is an important preventable cause of death. Those patients who survive may have a prolonged period of debility caused by failure of key body organs. We suspect that an important contributor to this organ failure may be dysfunction in the network of small blood vessels that supply the bodies organs with oxygen and nutrients. Our study will examine the link between the microcirculation and organ failure in patients who have suffered significant bleeding after traumatic injury. We will also explore the relationship between resuscitation of the global circulation (blood pressure, cardiac output etc.)an area that is monitored in clinical practice with the state of the microcirculation, which by contrast is not monitored. Patients with severe traumatic injury commonly have problems with blood clotting. Some researchers have suggested that microcirculatory failure may be an important contributor to this problem and we will explore this in more detail. Finally, we will attempt to examine some of the mechanisms by which the microcirculation may be disrupted by trauma and subsequent bleeding. These may include inappropriate activation of white blood cells, inadequate function of oxygen carrying red blood cells and changes to the cells lining the small blood vessels.

We will use a non invasive method to assess the microcirculation termed Side Stream Dark Field microscopy. This involves recorded a video image of the movement of blood within the small blood vessels under a patients tongue. In addition we will use ultrasound to assess the flow of blood from the heart. Small samples of blood will be taken to assess blood clotting and to look at possible mechanisms of microcirculatory dysfunction.

We aim to study ten patients in the first instance. The study will be carried out within the intensive care units at Kings College Hospital.


Eligibility Criteria:
Inclusion Criteria History of traumatic injury received blood products prior to ICU admission

Exclusion Criteria:

Not expected to survive 24 hours
Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery

The primary purpose of the study was to compare the macular hole closure and visual acuity gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus C3F8 gas tamponade with 14 days of face-down positioning.

The secondary purpose was to report, in each group, the cumulative incidence of cataract development 1 year following macular hole surgery and the proportion of complications (\*).

((\*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This prospective randomized study examined a 3 year period. The first patient was included in January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011 to December 2012. The first group included 31 patients who had undergone macular hole surgery using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively (SF6 group). These patients were compared to 28 patients who had undergone macular hole surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days. Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and fluid-gas exchange using either SF6 or C3F8.

Preoperative data included the characterization of the hole with Optical Coherence Tomography (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in number of letters (EDTRS chart) and determination of cataract development and extraction as needed.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic MH of stage 2-4 according to Gass classification (confirmed by fundoscopic examination and OCT) was included.

Exclusion Criteria:

* Exclusion criteria includes: patients with a chronic macular hole (symptoms more than 12 months duration), base diameter of the hole larger than 0.5 disc area diameter, medias opacities that prevent fundus visualisation until the second branches of central retinal artery, age-related macular degeneration ARMD, diabetic retinopathy, past history of retinal detachment or vitrectomy and corneal pathology disrupting vision.
Development of Molecular Diagnostic Platform for Tuberculosis

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy

Exclusion Criteria:

* Under 18 years
Reduced Intensity Double Umbilical Cord Blood Transplantation

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Subjects will receive their transplants as in-patients.

* IV-Catheter

  * one or two IV catheters will be placed on the day of hospital admission
* Conditioning

  * Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
  * Melphalan IV (day -1)
  * Total body radiation on day 0 (same day as transplant)
* Immunosuppressive Therapy

  * Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient
* Infusion of Cord Blood units

  * 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided

Eligibility Criteria:
Inclusion Criteria:

* Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
* Appropriate candidate for reduced intensity regimen, according to the treating physician
* Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
* Able to comply with the requirements for care after allogeneic stem cell transplantation

Exclusion Criteria:

* Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
* Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
* Renal disease
* Hepatic disease
* Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
* HIV-positive
* Uncontrolled infection
* Pregnant or breast-feeding