cyrilzakka/clinical-trials huggingface dataset:
The Preliminary Effects of Henna on CIPN

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common long-term toxicities of chemotherapy. Though, CIPN is one of the common symptoms encountered by oncology nurses in care of patients. For this reason, there is a need for an intervention that could decrease or prevent of CIPN.

Chemotherapy-induced peripheral neuropathy (CIPN) is frequently seen in patients receiving oxaliplatin-based therapy.This parallel group randomized controlled pilot clinical trial aimed at investigating the feasibility and preliminary effect of henna on CIPN in women receiving oxaliplatin-based therapy. This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received oxaliplatin-based therapy in the oncology clinic every fifteen days.

In order to calculate the sample size, it was decided to recruit 30 female patients to each group (intervention and control) using the G.Power-3.1.9.2 program. A total of 60 female patients were included in the study.

The study consists of two groups. In the intervention group, after the 2nd and 3rd chemotherapy cycles, henna application was applied to the hand-foot and toes. The control group underwent only the routine treatment.

To collect data, a personal information form and Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) were used.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older women
* Must the level of neurotoxicity is Stage II and Stage III
* Must taken at least one chemotherapy cycle and is planned to continue 2 chemotherapy cycles
* Be taking Folfox-6 chemotherapy protocol

Exclusion Criteria:

* Having an open wound and edema in the hands and feet
* Having a peripheral neuropathy due to diabetes and autoimmune diseases
* Using any complementary and alternative (CAM) treatment method to prevent peripheral neuropathy during administration
Comparison of Clenpiq vs Golytely Bowel Preparation

This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.

The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

* Creatinine clearance less than 30 ml/min
* History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
* Small bowel obstruction, ileus or bowel perforation
* Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
* Gastroparesis
* Toxic megacolon or undergoing colonoscopy for decompression
* Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
* History of prior colorectal surgery
* Allergy to any of the ingredients in Clenpiq or golytely
* if the procedure is planned in the intensive care unit (ICU)
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma

This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy.

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of relapsed high-risk neuroblastoma,Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma, synovial sarcoma
* Patient may have gross tumor that has been treated with multi-agent chemotherapy prior study entry, but does not need to have gross tumor prior to study entry.
* Patients must have had a diagnosis of neuroblastoma or sarcoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
* Have received standard chemotherapy and/or SCT, and are at least 6 months post-transplant.
* Age: Patients must be 1 - \< 25 years of age when registered on study.
* Organ Function Requirements: All patients must have adequate organ function defined as:
* Hematological Function: ANC ≥ 500; Platelet count ≥ 75.
* Renal Function: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR A maximum serum creatinine (mg/dL) based on age/gender as follows: 1YO M\&F = 0.6, 2-5YO M\&F = 0.8, 6-9YO M\&F = 1, 10-12YO M\&F = 1.2, 13-15YO M = 1.5, 13-15YO F = 1.4, 16+ M = 1.7, 16+ F = 1.4
* Cardiac Function: Patient must have normal cardiac function documented by Ejection fraction (\> 55%) documented by echocardiogram or radionuclide MUGA evaluation OR Fractional shortening (≥ 28%) documented by echocardiogram
* Liver Function: Total bilirubin ≤ 1.5 x normal for age, AND SGPT (ALT) and SGOT (AST) ≤ 3 x normal for age.
* Room air pulse oximetry \>94%.
* Male and female sexually active patients of reproductive age who wish to participate must agree to use acceptable contraception.
* Lansky performance scale \> 70, ECOG \< 2 (Appendix I).

Exclusion Criteria:

* Patient is pregnant.
* Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
* Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
* Patient is receiving concurrent systemic steroid therapy.
* Patient has a known systemic hypersensitivity to DAC, Hiltonol, or any vaccine component.
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
* Patients with single nodule.
* Before IIB period according to the eighth edition of the TNM staging period.
* No mediastinal lymph node metastasis.
* No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
* Eastern Cooperative Oncology Group performance status of 0 to 1
* Sufficient organ functions

Exclusion Criteria:

* Active bacterial or fungous infection.
* Simultaneous or metachronous (within the past 5 years) double cancers.
* Patients with contraindications to radiofrequency ablation and inability to complete treatment;
* Women during pregnancy or breast-feeding.
* Uncontrollable diabetes mellitus.
* Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery
Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized double-blind trial.

Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.

Previous studies of NF2 patients treated with bevacizumab suggested that inhibition of vascular endothelial growth factor (VEGF) could result in hearing improvement and reduction in tumor size.Recombinant human endostatin can inhibit the formation of blood vessels by inhibiting the migration of vascular endothelial cells .In this way, endostatin can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. In vitro tests, endostatin can inhibit the cell migration and Tube formation of the microvascular endothelial cell line HHEC. Besides, it can inhibit blood vessels' formation of the chicken embryo sac membrane. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of endostatin on NF2.

Eligibility Criteria:
Inclusion Criteria:

* 1)Patients must be at the age of 16-30
* 2)Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
* 3)Patients must not be treated with other drugs or radiation therapy recently
* 4)Patients should live in Beijing or nearby and can be treated in hospital
* 5)Patients must be healthy and not be seriously allergic with biological agents
* 6)Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.

Exclusion Criteria:

* 1)Treated with other drugs, surgery or radiation therapy recently
* 2)Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
* 3)Being pregnant or try to get pregnant, lactating women
* 4)With acute or chronic infectious diseases
* 5)With heart diseases, cardiac dysfunction or abnormal ECG
* 6)With uncontrolled neural or mental diseases, poor compliance
* 7)Not available for enhanced MRI
* 8)Take part in any other clinical trial
* 9)With other conditions that are considered not suitable for this clinical trial.
Compass Course: COVID-19

A group of clinicians and researchers developed an 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives. Participating in this research will involve an introduction session, where informed consent will be obtained, followed by the 8-session intervention for 9 sessions in total.

A team composed of researchers from Courage Kenny Rehabilitation Institute (CKRI) propose to recruit a convenience sample of individuals who were hospitalized with COVID-19 to evaluate the efficacy of administering the Compass Course to a novel population, to improve psychological well-being, engagement in everyday activities, and purpose in life.

A focus group will be scheduled 2 months after the completion of the Compass Course. This session is composed of brief questionnaires and designed to obtain post-course data to help evaluate the Compass Course intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years of age;
* Are part of the Allina Health COVID Research Registry or are receiving/have received therapy services for COVID-19 related sequelae at CKRI;
* English speaking
* Graduated from high school
* Able to see, hear, speak (with or without assistive devices)
* Access to computer or tablet and adequate internet connection to participate in video conference
* Has an email address;
* Own a smartphone with one of the following operating system versions:

iOS 9.0 - 9.3, 10.0 - 10.3, 12, 13.3, 13.7, 14.0 - 14.4 or later Android 8.0 - 8.1.0, 9, 10, 11 or later

* Agree to use personal smartphone to download mEMA application and respond to application notifications (mEMA is described in Sections 3.2.3.1 and 3.2.4.2.2);
* Willing and able to commit to attend all intervention sessions

Exclusion Criteria:

* History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning;
* Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)

Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.

Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography.

Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* absence of teeth at anterior maxilla
* need of vertical or horizontal bone reconstruction at anterior maxilla

Exclusion Criteria:

* smoking habits
* diabetes
* systemic diseases which interfere with osseous metabolism
* active periodontal disease
Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.

The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.

The investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.

Eligibility Criteria:
Inclusion Criteria:

* Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)

Exclusion Criteria:

* All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
Cyclophotocoagulation in Primary Open Angle Glaucoma

The use of Cyclodestruction procedures has been extended to patients with non-refractory glaucoma and good vision. Our aim is to compare the safety and efﬁcacy of three cyclodestructive treatments; High Intensity Focused Ultrasound (HIFU) Cyclocoagulation versus micropulse cyclophotocoagulation (MP-CPC) versus transscleral continuous wave cyclophotocoagulation (CW-CPC) for the treatment of Primary open angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* medically uncontrolled, primary open angle glaucoma attending glaucoma clinic

Exclusion Criteria:

* patients with history of previous laser or surgical intervention
Effects of Adapted Physical Activities on Visual Motor Integration in Children With Developmental Delay

Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Visual motor integration (VMI) is the ability of the child's hands and eyes to work together to guide their movements. Visual motor integration is a broad term encompasses cognitive as well as manual domains. This study will focused on the Manual Dexterity and intra-limb coordination (VMI). And it will evaluate the effects of adaptive physical activity on Visual Motor Integration.

Adaptive physical activities (APAs) are exercises and games that have been specially designed to fulfil the unique needs and skills of special needs or developmental delays.

Randomized control trial will be conducted with sample size 30, used to compare the effectiveness of adaptive physical activity on visual motor integration in children with developmental delay. subjects with developmental delay meeting the predetermined inclusion and exclusion criteria will be divided into two groups using non-probability convenient sampling. pre and post assessment will be done by Box and Block Test, Box and Ball Test, Discrete horizontal finger tapping test, Discrete vertical finger tapping with ball and continuous Vertical tapping with ball. subjects in group A will receive Baseline therapy and conventional therapy and group B will receive baseline therapy and adaptive physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age group 3-6 (both Gender Male \& Female) (39)
* Gross Motor Function Classification System, Level I
* \& II (45)
* Manual Ability Classification System (MACS) levels
* 1-3 (46)
* Pre assessed Developmental delayed.

Exclusion Criteria:

* Visually impaired Child
* Children with co-morbidities such as Epilepsy, Hydrocephalus
* Fractures, contractures or conflicting concurrent treatment impacting motor Functioning
* Children with significant cognitive impairments.
* Children who have received specific interventions targeting Visual motor integration, manual dexterity or intra-limb coordination
Expanded Access to VAL-083

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patient has relapsed/refractory disease and exhausted all standard treatments.

Exclusion Criteria:

* Patient is eligible for a VAL-083 clinical trial.
* Patient has previously received VAL-083 for the same disease.
Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty

This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. Second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. Third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups.

The investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. The investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. The investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective, primary total hip arthroplasty
2. Use of Cementless Total Hip components
3. Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis

Exclusion Criteria:

1. Prior surgery on the affected hip
2. No implanted medical devices or metallic debris in the patient which will preclude use of MRI
3. patients must be able to participate in standard post-arthroplasty rehabilitation protocols.
Efficacy of Zinc in the Treatment of Pneumonia

This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.

This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.

Eligibility Criteria:
Inclusion Criteria:

* children under two years old hospitalized with Pneumonia

Exclusion Criteria:

* healthy children