cyrilzakka/clinical-trials huggingface dataset:
Effect of Structured Training Program in Diabetic Patients

Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:

What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?

Group 1:

Patients in group 1 will receive a structured exercise program.

Group 2:

Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus with moderate to severe DPN
* Subjects of both gender
* Age from 40 to 70 years
* Independent walking
* MNSI score more than 2 out of 13

Exclusion Criteria:

* Presence of an active planter ulcer
* History of surgery during intervention period
* Neurological diseases other than DPN
Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block

Perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. Regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia. In recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. There are few studies in the literature comparing ilioinguinal iliohypogastic nerve block and quadratus lumborum block in children.

Perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. Providing effective perioperative analgesia reduces surgical stress, making the postoperative period more comfortable both physiologically and psychologically, effective postoperative pain control reduces the length of stay in the hospital, and also contributes to the long-term positive personality development of children.

Physiological, pharmacokinetic and pharmacodynamic differences in children delay the metabolism and excretion of systemic analgesics, resulting in a prolonged effect and an increased risk of apnea. Regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia.

Caudal block, which is a common regional anesthesia practice in inguinal hernia surgery in children, has disadvantages such as motor block and urinary retention. With the introduction of ultrasonography, peripheral block techniques such as transversus abdominis plane block and ilioinguinal iliohypogastric nerve block have been shown to provide effective and safe analgesia and have replaced central blocks. In recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. There are few studies in the literature comparing ilioinguinal iliohypogastric nerve block and quadratus lumborum block in children.

The purpose of the study to compare the postoperative analgesic effectiveness of quadratus lumborum block and ilioinguinal iliohypogastric block in pediatric patients who underwent unilateral inguinal hernia operation.

Eligibility Criteria:
Inclusion Criteria:

* who were scheduled for unilateral inguinal hernia operation
* with American Society of Anesthesiologists (ASA) physical score I-II
* aged 2-7 years

Exclusion Criteria:

* Patients with coagulopathy
* skin infection at the block application site
* bupivacaine allergy
* neuropsychiatric disease
Beyond Bias - Reducing Provider Bias Towards Adolescents to Increase Contraception Take-Up in Tanzania, Burkina Faso, and Pakistan

Beyond Bias will evaluate the impact of an intervention designed to reduce family planning provider bias towards young, unmarried, and nulliparous women in Tanzania, Burkina Faso, and Pakistan. The intervention has three components: 1) a summit that includes impactful stories told to and by family planning providers that highlight the consequences of provider bias, 2) a forum for continued communication between providers, and 3) a rewards program where clinics in which providers exhibit less biased client interactions or who have improved the most towards this end will be rewarded with social recognition and a ceremony.

Half of the eligible clinics in each country (233 in total) are randomly assigned to receive the intervention, while the remaining half serves as control. The objective of the evaluation is to estimate the impact of the intervention on a range of outcomes related to quality of family planning care among young, unmarried, and nulliparous women. The investigators hypothesize that the intervention will increase the share of young, unmarried, and nulliparous women who received counseling on a range of methods, counseling on long acting methods, and who received their preferred method.

The investigators will collect four types of data to evaluate the intervention: 1) provider surveys, 2) mystery clients' visits, 3) direct observations of client-provider interactions, and 4) qualitative interviews with clients, providers, and implementors.


Eligibility Criteria:
Inclusion Criteria for Providers:

* All providers that are part of Pathfinder Internal's supported clinic network in Burkina Faso, Tanzania, and Pakistan.

Exclusion Criteria for Providers:

* None

Inclusion Criteria for Clients:

* All clients aged 24 or under that visit a clinic that is enrolled in the study

Exclusion Criteria for Providers:

* Clients over 24
* Clients who do not visit the clinic for family planning services
The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery

The purpose of this study is to investigate the efficacy of intravenous lidocaine on THBS2, MMPs and VEGF-C in serum in cervical cancer patients undergoing radical hysterectomy under general anesthesia.

The surgical stress response to tumour removal causes bloodstream release of a variety of pro-inflammatory cytokines and other molecules which may affect perioperative immune response and other conditions conducive to residual tumour cell survival that could later emerge as clinical recurrences or metastasis. Lidocaine has analgesic and anti-inflammatory effects, and may also have specific anticancer properties.

Blood serum expression of these molecules (metalloproteinases, vascular endothelial growth factor \[VEGF\], epidermal growth factor）, play a important role in the metastatic process and tumor progression. lidocaine could affect the course and growth of metastatic tumors by changing the cancer cells, the tumor microenvironment, or both.

We tested the hypothesis that women undergoing cervical cancer resection with these techniques (intravenous lidocaine) have reduced postoperative serum expression of metastasis biomarkers, and may change the outcomes of cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients were scheduled by following cervical cancer surgery under general anesthesia
* Aged 18-65 years
* ASA physical status Ⅱ-Ⅲ

Exclusion Criteria:

* Severe heart, pulmonary, hepatic and renal insufficiency
* History of neurological diseases
* Autoimmune disorders
* Antiarrhythmic drugs (amiodarone, verapamil, propafenone)
* Patients' decision to withdraw anytime from the study, and refusal to participate before surgery and at postoperative follow-up
* Allergy to one of the used medications
* Psychiatric illness, psychological disorder, and drug or alcohol abuse
* Unwillingness to comply with the protocol or procedures
* Preoperative treatment of chemotherapy, radiation, NSAID and hormonal therapy
* History of anesthesia and surgery in two weeks
* Coexisting other cancers and intraoperative presence of liver metastasis
* Perioperative treatment of blood transfusion
A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease

The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
2. Negative pregnancy test prior to the conduct of any protocol-specific procedure. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
3. Signature of the subject on the Informed Consent Form
4. Willing to avoid disallowed medication for the duration of the study.
5. Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
6. Able and willing to follow study instructions
7. Additional inclusion criteria also apply

Exclusion Criteria:

1. Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study).
2. Use of contact lenses during the study.
3. Use of any concomitant topical ocular medications except for artificial tears during the dosing period
4. Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
5. Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
6. A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
7. Known hypersensitivity to any component of the study drug or procedural medications
8. Participation in any other clinical trial within 30 days prior to screening
9. Known hypersensitivity to NSAIDS
10. Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit
11. Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK)
12. Cataract surgery within the past year.
13. Known contraindication to the study drugs or any of their components
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.

Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) Class II or III
* Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
* Left ventricular ejection fraction \>20% and \<40%
* On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
* NTproBNP level of \>500 pg/ml
* Autologous cell analysis score consistent with study selection assessment

Exclusion Criteria:

* Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

Primary aim:

The primary aim of the study is to compare survival to discharge (or survival to 14 days post-operatively, whichever comes first) following emergency surgery for traumatic brain injury (TBI) across Human Development Index settings.

Primary outcome measure:

The primary outcome measure will be survival to discharge (or survival to 14 days post-operatively, whichever comes first)

Primary comparison:

Between country groups defined by human development index.

Centre eligibility:

Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate.

Patient eligibility:

All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.

Team:

Individual hospital teams with up to four people, collecting data for 30 days.

Time period:

Local study teams may select any 30-day period from the 1st of November 2018 and the 31st of December 2019 to start their study. Patients operated on who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included.

Validation:

We will employ a method of data validation in every centre that will give us a quantitative estimate of case ascertainment that is feasible even in low-resource centres.


Eligibility Criteria:
Centre Inclusion Criteria:

Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. In the majority of institutions, emergency surgery for TBI is provided by neurosurgeons - however, centres in which emergency surgery for TBI is provided general surgeons, trauma surgeons, general medical doctors or even non-physician clinicians are also eligible to participate.

Inclusion Criteria:

- All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.

Exclusion Criteria:

* Patients who only have an external ventricular drain or intraparenchymal wire (or other monitoring device) inserted for the diagnosis and/or management of intracranial hypertension.
* Patients who undergo procedures for chronic subdural haematoma(s), including burr holes or mini-craniotomies.
* Elective (planned admission) or semi-elective (where patient initially admitted as an emergency, then discharged from hospital, and re-admitted at later time for surgery) procedures.
* Patients who have previously had emergency cranial surgery for traumatic brain injury rendering them eligible for inclusion in this study (regardless of whether they were included)
Endometrial Cancer - LOHP Alone and With 5FU

To determine the efficacy (response rate \[RR\], time to progression and survival) of oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of the above mentioned regimens in these patients


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years, with locally advanced, recurrent or metastatic endometrial adenocarcinoma, histologically diagnosed; at least 1 bidimensionally measurable lesion (\> or =to 2 cm on computed tomography \[CT\]/magnetic resonance imaging \[MRI\] or \> or =to 1 cm clinical lymph node confirmed by ultrasound or \> or =to 1 cm skin lesion confirmed by photograph with ruler) located in a non-irradiated area measured less than 2 weeks before inclusion, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
* Patients previously treated for locally advanced/metastatic disease with chemo-radiotherapy (total CDDP dose \> or =to 100 mg/m2) or chemotherapy containing CDDP or carboplatin with at least 4 weeks' washout period from discontinuation of prior chemotherapy and fully recovered from toxic effects of prior chemotherapy (except for symptomatic peripheral neuropathy \< or =to NCI-CTC grade 1 or alopecia).
* Patients with clinically or radiologically documented PD or recurrence during or after last chemotherapy and hormone therapy (hormone therapy stopped before study entry), Eastern Cooperative Oncology Group performance status (ECOG PS) \< or =to 2, life expectancy \> or =to 3 months, adequate bone marrow reserve, normal renal and liver function (neutrophil count \> or =to 2000/mm³; platelet count \> or =to 100 000/mm³; creatinine levels \< or =to 1.5 x the upper limit of normal \[ULN\] of institutional values or creatinine clearance \> 60 mL/min; total bilirubin level \< 1.5 x ULN; \[alanine amino transferase/aspartate amino-transferase \< 2.5 x ULN without liver metastases, \< 5 x ULN with liver metastases\]).
* Laboratory values obtained in the week preceding study entry.
* Signed informed consent (prior to all study procedures)
A Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies

Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Because SVV and PPV are generated by the pressure transmitted from the airways to the pleural and pericardial spaces, their reliability is limited in patients receiving low tidal volume (VT) ventilation and in those with a driving pressure lower than 20 cm H2O.

Lung-protective ventilation using low VT with positive end expiratory pressure (PEEP) has recently been demonstrated to significantly improve postoperative outcome, and its application is gradually increasing in surgical patients. However, protective ventilation alters the predictability of dynamic preload indices and thus limits their use in the operating theatre.

Lung recruitment maneuvers (LRMs), used to reopen collapsed lung, and PEEP have been proposed as the key components of lung-protective ventilation strategy. LRM increases intrathoracic pressure, which in turn causes a transient decrease in stroke volume (SV) and arterial pressure; this may depend on preload status. Interestingly, recent study reported that the augmented PPV during LRM using vital capacity maneuver (VCM, continuous positive airway pressure of 30 cm H2O for 10 s) could predict preload responsiveness under open chest condition.

Investigators hypothesized that the augmented PPV and SVV by a stepwise LRM with incremental PEEP could represent a functional test to suggest preload responsiveness and, therefore, predict fluid responsiveness. The aims of the current study were (1) to assess the ability of augmented PPV and SVV during stepwise LRM-induced to predict fluid responsiveness in mechanically ventilated patients in the operating room, (2) to assess the ability of stepwise LRM-induced decrease in SV (ΔSV-LRM) to predict fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving laparotomy and lung protective ventilation

Exclusion Criteria:

* preoperative arrhythmia
* Severe bradycardia
* Moderate to severe valvular disease
* left ventricular ejection fraction \< 50%
* Poorly controlled hypertension (systolic BP \> 160 mmHg)
* Patients with renal insufficiency (creatinine \> 1.5 mg/dL)
* Moderate to severe liver disease
* BMI \>.30 or \< 15 kg/ m2
* preexisting pulmonary disease
* FEV1 \< 60% of predicted value