cyrilzakka/clinical-trials huggingface dataset:
Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain

Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is useful for disorders associated with neck and arm pain. This study aimed to determine the effects of NM on respiratory function in patients with chronic neck pain.

Methods: Overall, 26 patients with neck pain were randomly assigned to two groups: NM or control. In these participants, respiratory function and active cervical range of motion were assessed before and after intervention. Furthermore, the participants were provided a visual analog scale (VAS) and Fremantle Neck Awareness Questionnaire (FreNAQ). Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 25-65 years,
* those with neck pain for \>3 months
* those with complaints of pain, tension
* numbness on neurodynamic nerve tests

Exclusion Criteria:

* individuals with spinal stenosis,
* neurological diagnosis, malignancy,
* upper extremity vascular problems,
* osteoporosis,
* pregnancy,
* history of newly repaired peripheral nerves,
* inflammatory processes,
* cervical spine and upper extremity surgeries,
* conditions affecting lung capacity (such as asthma, bronchitis, and diabetes mellitus)
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with interstitial lung disease
* Clinically stable
* Written informed consent signed

Exclusion Criteria:

* Allergic to cell therapy;
* Patients with serious significant pulmonary infection need anti-infection treatment;
* Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
* Patients with malignant tumor in the past 5 years;
* Participated in other clinical trials in the past 3 months;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ)
* Pregnant or lactating women;
* The investigator assessed as inappropriate to participate in this clinical trial.
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.


Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent
* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Unsatisfactory effect of pharmacological treatment

Exclusion Criteria:

* Microvascular decompression is seen as a better alternative
* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Anomalies which hinder or impede the used method of injection
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
* Treatment with medication that can interact with botulinum toxin type A
Safety Study of NK Cells From Sibship to Treat the Recurrence of HCC After Liver Transplantation

The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.

Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With the advancement of liver transplantation associated science and technology, the recurrence of tumor posttransplantation has become the principal contradiction to worsen the prognosis and therefore the prevention of recurrence of HCC is the key to improve the efficacy of liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant tumors including HCC and has obtained significant effects. But for patients with liver transplant in immunosuppressed states, to successfully apply the immune cells to prevent and treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it is also necessary to consider the effectiveness of treatment that the immune cells in the immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells for GVHD, and might be an optimum choice to meet the above requirements.

Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the study will be assigned to one of three treatment arms:

Arm A: Participants will received conventional treatment and low dose of NK cells treatment for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK cells treatment for 4 times. Arm C: Participants will received conventional treatment and normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral blood of the same blood type were taken and infused at intervals of two weeks. Periodic liver function recheck and imaging examination were conducted for 6 months after the last NK cells infusion.

Eligibility Criteria:
Inclusion Criteria:

* Proved hepatocellular carcinoma histologically after liver transplantation.
* Confirmed recurrence of hepatocellular carcinoma by CT/MRI.
* The same blood type relatives with blood transmitted diseases negative.
* Written informed consent.

Exclusion Criteria:

* Autoimmune diseases require long-term of glucocorticoid.
* Other candidates who are judged to be not applicable to this study by investigators.
* Poor compliance.
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin

A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin


Eligibility Criteria:
Inclusion Criteria:

* Participated in the prior phase 3 study (Protocol No: DW_DWP16001302) for meeting the inclusion criteria and completed the study
* Voluntarily decided to participate in the extension study and provided a written consent on the consent form

Exclusion Criteria:

* Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator
* Subjects with the following diseases or signs:

  * Diabetic ketoacidosis
  * Moderate to severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2
* Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study

Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:

① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or

② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or

③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above
ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.


Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure
* left ventricular ejection fraction \< 45%
* New York Heart Association (NYHA) index ≥ 2
* Sleep apnea syndrom confirmed by polysomnography

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease with maximal Respiratory Volume \< 50%
* Resting oxygen saturation \< 90%
* Continuous Positive Airway Pressure (CPAP) or Adaptive Servo-Ventilation treatment
* Life expectancy \< 1 year for other medical reasons than heart failure
* Cardiac surgery
* Percutaneous transluminal coronary angioplasty
* Unstable angora during the 6 last months
* Implantation of a pacemaker or a defibrillator during the 6 last months
* Cerebrovascular accident or Transient Ischemic Attack during the 3 last months
* Restless legs syndrome
* Acute myocarditis or pericarditis during the 6 last months
* Valvular disease
* Pregnancy
Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?

Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes

Eligibility Criteria:
Inclusion Criteria:

1. Patient has given written informed consent
2. BMI 18-30 kg/m2
3. \< 2 previous failed IVF trials
4. At least two good quality embryos on the day of transfer

Exclusion Criteria:

1. Congenital uterine anomaly
2. Untreated endometrial polyp or fibroid distorting uterine cavity
3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure

5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history
Anticoagulation in Patients With Venous Thromboembolism and Cancer

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns,healthcare resource utilisation (HCRU), direct and indirect costs (where feasible), and safety and effectiveness outcomes in patients with VTE and active cancer or patients with VTE and history of cancer who initiate anticoagulant treatment with a VKA, LMWH or NOACs.


Eligibility Criteria:
Inclusion Criteria:

* A VTE diagnosis
* Active cancer or history of cancer
* Treatment with VKA, NOAC (apixaban, rivaroxaban, dabigatran, edoxaban) or LMWH
* Age ≥ 18 years at the date of index VTE (Venous thromboembolic)

Exclusion Criteria:

* Prior VTE diagnosis
* Diagnosis of prior atrial fibrillation
* Inferior Vena Cava (IVC) filter
* Prior exposure to (OAC) oral anticoagulation or (PAC)parenteral anticoagulation - note: Prophylactic use of (OAC)/(PAC) allowed.
* Pregnancy
* More than one (OAC) oral anticoagulation or (PAC) parenteral anticoagulation dispensed on the index date.
* Patients with less than one day of follow up
Mantram Repetition Meditation for Veterans With PTSD

The aim of this study was to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.

The investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control condition of Present Centered Therapy (PCT) in a diverse sample of Veterans with post-traumatic stress disorder (PTSD). Primary outcomes included clinician-assessed and self-reported PTSD symptom severity. Secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. Veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the Department of Veterans Affairs healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Read and write English fluently
* Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma
* Transportation to attend meetings and available to complete study protocols
* Stable dose and type of PTSD medications for at least 6 weeks (per chart review)
* Willing to track medication changes during study

Exclusion Criteria:

* Inability to give informed, voluntary consent
* Cognitive impairment sufficient to cause inability to complete the protocol
* Psychotic symptoms
* Dementia or other organic mental disorders that may cause inability to complete the protocol
* Significant documented alcohol/substance abuse
* Presence of severe suicidal urges or intent
* Residence in a geographical area outside of San Diego County or Bedford, Massachusetts area
* Current daily practice of any skills of any meditation-based program - including, but not limited to:

  * Transcendental Meditation (TM)
  * Yoga
  * Tai Chi
  * Qi-Gong
  * Vipassana or Insight Meditation
  * Loving-Kindness or Compassion Meditation
  * Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program
  * Guided Imagery
  * Mantram Repetition
  * Passage Meditation
  * Walking Meditation
  * Zen or Buddhist meditation
  * Self-hypnosis, Bio-feedback, etc.
* Other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.
Vancomycin Resistant Enterococci in Patients Awaiting Liver Transplantation at the University of Michigan: Prevalence, Risk Factors, Natural History and Outcome of Colonization

Enterococci, especially vancomycin resistant enterococci (VRE), are increasing in prevalence in many hospitals in the United States. Patients undergoing liver transplantation are at particular risk for developing infection due to VRE. The effect of prior colonization with VRE on the outcome of liver transplantation is unknown. This prospective study will ascertain the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among patients awaiting liver transplantation at the University of Michigan Health System. Risk factors for acquisition of the organism, natural history of colonization and outcome in colonized patients will also be determined. All patients currently listed on a priority waiting list for liver transplantation at UMHS will be invited to participate. Patients will receive a standardized letter from their primary gastroenterologist describing the rationale for the study. Patients will be contacted by telephone by a member of the study team in order to arrange an appointment in the GCRC at the time of their regularly scheduled Transplant Clinic appointment in order discuss their potential participation in the study. Patients who give informed consent, will be interviewed using a standard interview questionnaire. Demographic and historical data relevant to the risk of VRE colonization will be collected during the interview. A sample will be obtained via rectal swab for culture. Rectal swabs for culture and collection of information on the standardized questionnaire will be repeated every six months while the patient is awaiting liver transplantation. When a patient undergoes liver transplantation, a culture will be obtained at the time of admission and weekly after post-operatively until discharge. All patients will be followed for 60 days after transplantation to assess several primary outcomes, including operative and post-operative complications, VRE infection and mortality. Rectal swabs will be the only procedure performed for the purposes of this study. Culture results will not be made available to the transplant team in order to avoid bias in clinical care. All data will be entered into an electronic database. GCRC statisticians will assist in the analysis of risk factors and outcome analysis.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years or older currently listed on a priority waiting list for liver transplantation at the University of Michigan will be invited to participate.
Telemonitoring of Chronic Wound Patients Using MyDerm, a Digital Solution: Feasibility Study

The aim of this study is to assess the feasibility of integrating myDerm for remote monitoring of chronic wounds into everyday practice, for patients over 18 years of age suffering from a single chronic wound of the lower limb (more than 6 weeks old).

Outcome measure 1 :

Evaluate patient satisfaction after 2 months of using the MyDerm solution.

Outcome measure 2 :

1. Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
2. Assess patient use (compliance, frequency) of MyDerm solution
3. Evaluate caregiver use of PIXACARE solution
4. Evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the MyDerm solution.
5. Evaluate the impact of patients' clinical characteristics on the use of the MyDerm solution.

Researchers will compare standard of care arm vs remote monitoring arm.

As part of remote monitoring, patients are invited to take photos of their wounds using their smartphone, and to answer a simple questionnaire to look for signs of complications. To assess satisfaction, the patient will complete a questionnaire after 2 months' use, using a 7-level Likert scale.

Observational, monocentric study of patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of wound healing.

Clinical data will be collected by the investigating team during the primary consultation.

Patient satisfaction surveys will be sent in paper format to patients at the consultation scheduled at the end of the two-month follow-up period.

Caregiver" satisfaction surveys will be sent in paper format to caregivers at the end of the study.

The number of actions taken in response to an alert (by telephone, by message, organization of a physical consultation, organization of a teleconsultation, hospitalization) will be recorded in the post-alert action traceability form

Eligibility Criteria:
Inclusion Criteria:

* Patient with a single chronic wound of the lower limb (more than 6 weeks)
* Benefiting from the MyDerm digital wound-healing monitoring solution
* Patient aged 18 or over
* Informed patient who has not objected to the use of data

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient included in a clinical trial
* Patient with a life expectancy shorter than the duration of the study
* Patient with cognitive impairment
* Inability to install or use the medical device for technical reasons (lack of internet connection, lack of 4G coverage or more, lack of smartphone)
* Patient requiring home hospital care
* Patient requiring Follow-up and rehabilitation care
* Pregnant or breast-feeding women
* Patient with a previously infected wound