cyrilzakka/clinical-trials huggingface dataset:
Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.


Eligibility Criteria:
Inclusion Criteria

* Adults aged \> 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
* Written informed consent
* Patients undergoing primary THA diagnosis of end-stage osteoarthritis
* Patients receiving spinal anesthesia
* Patients being discharged on postoperative day 1

Exclusion Criteria

* Patients with a TXA allergy
* Patients undergoing revision procedures
* Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
* Patients receiving general anesthesia
* Patients being discharged on the same day of surgery
* Cancer patients
* Patients with a history of prior VTE event
* Patients on preoperative anticoagulants other than ASA
* Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
* Female patients who are on hormonal contraception
* Patients with history of retinal vein or artery occlusion
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 1 insulin-dependent diabetic patients in relatively good general condition
* non-smoker
* body weight \< 80 kg
* C-peptide \< 0.03 nmol/l (\<0.09 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
* EBV antibody positive
* cooperative and reliable patient giving informed consent by signature; the patient should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of intervention and of immunosuppressive therapy; the patient should also be informed that withdrawal of immunosuppressive therapy in patients with persistent plasma C-peptide positivity may result in subsequent loss of ß-cell graft function; the ß cell implant should be identified as a clinical trial

Exclusion Criteria:

* history of thrombosis or pulmonary embolism
* abnormal liver function
* HLA antibodies
Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA

The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.

Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.

The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes and aged between 40 and 72 years.
* Diagnosed with osteoarthritis of the knee by radiological image.
* Pain in the joint equal to or greater than 2.5 points in EAV.
* Radiological severity:Value in the Ahlback score 3 or less.
* Body mass index between 20 and 30.
* Possibility for observation during follow-up period.

Exclusion Criteria:

* Bilateral Gonarthrosis requiring infiltration in both knees.
* Body mass index greater than 30.
* Diagnosed polyarticular disease.
* Severe mechanical deformation.
* Previous arthroscopy in the past year.
* Intraarticular infiltration of hyaluronic acid in the last 6 months.
* Rheumatic autoimmune systemic disease.
* Poorly controlled diabetes mellitus.
* Blood alterations.
* Immunosuppressive treatments and/or coumarinics.
* Treatment with steroids for 3 months prior to its inclusion in the study.
* Treatment with nonsteroidal anti-inflammatory drugs for 15 days prior to its inclusion in the study.
The Effects of Pre-operative Physical Therapy Education

It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.


Eligibility Criteria:
Inclusion Criteria:

* be over the age of 18,
* have a good understanding of the English language, and
* be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Exclusion Criteria:

* if they previously underwent one of the previously mentioned procedures mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.
Puff Biofeedback to Reduce Smoking Reinforcement

The purpose of the study is to examine the effects of a novel bio-behavioral paradigm, entitled, Puff Topography Biofeedback Training, compared to a control condition, in reducing stress-induced smoking reinforcement.

Smokers with emotional distress are particularly vulnerable to smoking reinforcement due to various biopsychological factors that contribute to deficits in emotion regulation and heightened reward processing, which undermine cessation efforts. Differences in puffing behavior may correspond with changes in cardiorespiratory parameters that may promote self-regulation and reduce craving.

This study is a between-subjects experimental test of Puff Topography Biofeedback Training (PTBT) and its ability to modify puff topography and cardiorespiratory activity during stress-precipitated smoking, and in turn, reduce acute smoking reinforcement.

Participants will be randomized to either PTBT or a Control condition and will complete two smoking trials on two successive days. The first smoking trial (Visit 1) will allow participants to gain familiarity with the task. The second smoking trial (Visit 2) will be completed following acute laboratory stress induction (stress-precipitated smoking trial).

The primary study aims are to test the effect of PTBT vs. Control as assessed via acute changes in stress-precipitated smoking reinforcement and changes in puffing behavior and cardiorespiratory parameters.The results of this high pre-intervention study could inform the subsequent development of a novel intervention strategy for improving quit outcomes in a treatment-resistant population.

The primary study aims are to test the effect of PTBT vs. Control in terms of: (a) objective puff topography parameters; (b) subjective reinforcement; and (c) whether physiological indices reflective of smoking reinforcement differ between conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Daily smoking ≥ 8 cigarettes/day verified by carbon monoxide analysis of breath sample ≥ 8 ppm
* Smoking within 30 minutes of waking
* English fluency.

Exclusion Criteria:

* Current smoking cessation treatment
* Past-month reduction of cigarettes/day by ≥50%
* Moderate or severe non-nicotine substance use disorder
* Past-year psychiatric instability (e.g., psychosis, mania)
* Severe visual, hearing, or cognitive impairments
* Medical condition that could impact stress reactivity or physiology
* Current regular use of medication that could affect cardiorespiratory function (e.g., beta blockers, benzodiazepines; note-use of SSRIs/SNRIs is permitted if dose is stable ≥ 6 wks).
Long Term Metformin in Women With Polycystic Ovary Syndrome

The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.

Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.


Eligibility Criteria:
Inclusion Criteria:

* PCOS phenotype A
* BMI≥ 25kg/m2
* metformin 1000mg twice a day for at least one year

Exclusion Criteria:

* PCOS phenotype B, C, D
* BMI \<25kg/m2
* had been treated with spironolactone or oral contraceptives alone or in combination with metformin
* had history of bariatric surgery
* became pregnant during the observation period
* had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year
Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain

Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks. There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the tightness of quadratus lumborum and erector spinae muscles

A randomized experimental controlled trial will be carried out to compare the effectiveness of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain. A total of 60 male and female volunteers having subjects with sub-acute nonspecific low back pain will be recruited in this study. Subjects will be assessed at baseline for pain and disability using Visual Analogue Scale and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform Muscle energy technique combined with conventional exercise; Group 2 will receive Myofascial Mobilization combined with conventional exercise. This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM\&R). Data will be analyzed using SPSS 21 and ANCOVA technique will be used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Sub-acute low back pain with the range of 7 to 12 weeks of unresolved symptoms.
* Positive test of tight Erector spinae muscle and Tight Quadratus Lumboram muscle

Exclusion Criteria:

* Spinal malignancy
* Spinal fracture
* Spine foraminal stenosis
* Nerve root compression
* Radicular symptoms
* Sciatica
* Cord compression
* Paralysis
* Muscular dystrophy
* Myelopathy
* Seizure disorder
* Severe trauma
* Unexplained weight loss
Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).

The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.

Patients assess their pain for 7 days after permanent root canal obturation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age \> 18 years old
* Patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth.
* Informed consent signed
* Patient with social protection.

Exclusion Criteria:

* Endodontic treatment on tooth with suspected root perforation, or immature tooth,
* Known allergy to corticosteroids, local anesthetics, or any component of the medical devices,
* Patient taking anti-pain or anti-inflammatory treatment regularly for another pathology,
* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
* Participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial,
* Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
Study of the Effects of Fabrazyme Treatment on Lactation and Infants

The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full participation of mother and no infant participation was 6 months.


Eligibility Criteria:
Inclusion Criteria:

Mothers that met the following criteria were enrolled in this study:

* provided signed written informed consent to participate in this study,
* be enrolled in the Fabry Registry and received Fabrazyme while lactating,
* agreed to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
* agreed to adhere to the schedule of evaluations for this study.

Infants that met the following criteria were enrolled in this study:

* had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
* born to a mother who was receiving Fabrazyme during lactation,
* received breast milk from the mother, and
* had the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.

Exclusion Criteria:

* The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
Telerehabilitation Protocols With Digital and Robotic Tools for People With Chronic Neurological Disorders

The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). The main questions it aims to answer are 1)the usability and acceptability of the system; 2)the level of safety of intervention; 3) the efficacy of the telerehabilitation protocol. Participants will be randomized (with an allocation ratio of 1:1) into either the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 motor rehabilitation sessions performed at home according to the usual care treatment procedure). Researchers will compare the experimental group and the active control group to see if the TR protocol with digital and robotic tools is effective in reducing the perceived level of disability.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of chronic post-stroke condition with ischemic or haemorrhagic stroke injury occurred 4-6months before recruitment and with motor impairment of the upper limb \> 2 to the Medical Research Council scale (MRC); or diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004); or diagnosis of MS, RR-SP forms, according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) \< 6;
2. age between 25 and 85 years;
3. preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>17.36) (Conti et al., 2015);
4. agreement to participate with the signature of the informed consent form;
5. no rehabilitation program in place at the time of enrolment;
6. stable drug treatment (last 3 months) with L-Dopa or dopamine agonists (PD group) and/or cortisone (MS group).

Exclusion Criteria:

1. presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
2. presence of major psychiatric complications or personality disorders;
3. presence of severe impairment of visual and/or acoustic perception;
4. relapse ongoing/at least 3 months since the last relapse (MS group);
5. presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
6. falls resulting in injuries or a number of falls ≤ 2 in the 6 months prior to recruitment (PD and MS groups).
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis

This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
2. Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
3. Male or Female between the ages 22 to 99.
4. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
5. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject or Primary Caregiver must be competent to follow all study procedures.
7. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period of time (up to 120 days), for a minimum of 30 hours/ week.

Exclusion Criteria:

1. The subject cannot be pregnant, or nursing.
2. The subject cannot be sensitive or allergic to adhesives or tapes.
3. The subject may not be enrolled in another Clinical Trial.
4. The subject is homeless or in a home without a power supply.
Metabolomic Response to Meal Ingestion

The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.


Eligibility Criteria:
Inclusion Criteria:

* non obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)

People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.

Patients with cancer are thought to have a weakened immune system and small observational case series have suggested patients with cancer are at a higher risk of poor outcome from COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not known. In addition, it is unclear when it is appropriate for cancer patients who have recovered from COVID-19 infection to resume anti-cancer therapy.

There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly determine whether the virus has been cleared of the COVID-19. Lateral flow assays investigated in this study are rapid and simple diagnostic tools which can assist in timely diagnostics to inform clinical decision making.

This observational study aims to describe the immunological dynamics and clinical course of COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays.

The information from our study will add significantly to the understanding of COVID-19 diagnostics and will improve the evidence-base for the management of cancer patients. Furthermore, data from this study could inform the timing and treatment for cancer patients who have recovered from COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 RT-PCR
* Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid organ malignancy having received therapy (radiotherapy, chemotherapy or targeted agents)
* Patient is ≥ 18 years of age.
* Patient can understand the patient information sheet and is able to provide written informed consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.
A Neurofeedback Booster for Emotion Regulation Therapy

This is a proof-of-concept study that aims to test the additional value of adjuvant neurofeedback treatment for psychotherapy. Three sessions of real-time fMRI neurofeedback will be administered to N=22 patients with BPD while they receive residential Dialectical Behavior Therapy treatment. In addition, outcomes are assessed from a control group with same sample size who do not receive the treatment.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 BPD diagnosis
* informed consent
* EtOH and tox negative on the day of neurofeedback
* BSL-23 score \>=1.87 at DBT halftime

Exclusion Criteria:

* pharmacotherapy with opiates
* standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
* pregnancy
* epilepsy
* life-time diagnosis schizophrenia or bipolar disorder I
* significant current or past neurological illness
* BMI\<16.5
* usual safety criteria for magnetic resonance imaging