cyrilzakka/clinical-trials huggingface dataset:
The Effect of Neuromuscular Exercise Training on Balance, Jump and Trunk Endurance in Female Ice Hockey Players

The aim of the study is to investigate the changes in dynamic balance, vertical jump and trunk endurance parameters in athletes included in body weight neuromuscular program in addition to regular training programs.

As a randomization method, the participants will be divided into two groups as control and experimental groups by using a computer-based program and a simple randomization method. This study will be scheduled five times a week for six weeks. After the evaluations, all exercises will be taught to the experimental group by the physiotherapist. While the experimental group will apply to this program and traditional education, the control group will continue to the traditional education program. Since all exercises are done with body weight, no extra equipment will be needed. Reviews:

Balance evaluation: Y balance test The Vertical Jump Test will be used to evaluate muscle strength in the lower extremities.

McGill Trunk Endurance Test: To be used for Muscular Endurance Assessment.

Eligibility Criteria:
Inclusion Criteria:

* Being a licensed athlete of any team affiliated with the Turkish Ice Hockey Federation and competing in the league,
* Athletes who do not use any medication and do not have a medical condition that would interfere with the tests
* be between the ages of 15-30

Exclusion Criteria:

* Not having had a musculoskeletal injury in the last 1 year that would prevent him from training or that would affect the results of the measurements.
Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD

Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary diagnosis of OCD
* Sufficient severity of symptoms
* For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
* Able to provide consent

Exclusion Criteria:

* First degree relative with schizophrenia
* Psychiatric conditions that would make participation unsafe determined by study doctor
* Female patients who are either pregnant or nursing
* Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
* Nasal obstruction or history of nasal surgery
* Currently on psychotropic medication or other medication likely to interact with the glutamate system
* Medical conditions that make participation unsafe
* Allergy or intolerance to ketamine or midazolam
Efficacy of a Family Telephone Intervention for Stroke

The purpose of this trial is to determine if a family intervention administered by telephone to stroke patients and their caregivers increases adaptation and functioning after stroke.

Stroke is a major health problem which affects an estimated half million persons each year. In many cases family members assume the long-term burden of care after hospital discharge. Methods such as family education, peer support groups, and counseling are available to help meet the needs of caregivers, by enhancing their coping abilities. Family intervention also potentially benefits patients by improving the quality of caregiving skills. Few investigations have examined the benefits of family intervention methods.

This trial will study the effectiveness of a family-based, telephone-administered intervention called Family Intervention: Telephone Tracking (FITT) for acute stroke patients and their caregivers. Study patients will be recruited from those admitted to the Rhode Island Hospital following an acute stroke. All patients and caregivers will receive standard medical care. In addition, these patients and their caregivers will be randomly assigned to one of two treatment conditions: FITT or no intervention. Treatments will begin once the patient returns home and will continue for a six-month period.

During the trial, specially trained staff will carefully monitor the progress of the stroke patient and his/her family member, checking for changing in thinking, concentration, attention, memory, mood, and family functioning that sometimes occurs in stroke. Participants will be contacted by telephone every week for 6 weeks, then every 2 weeks for 2 months, and then monthly for 2 months. The telephone calls will check on how the participants are doing after discharge and will assist with questions and concerns.

Eligibility Criteria:
Inclusion criteria:

* age \> 35 years,
* MRI or CAT scan proof of stroke or definitive hemiplegia, and
* competency to sign an informed consent form.

Exclusion criteria:

* presence of subarachnoid hemorrhage, transient ischemic attack or subdural hematoma,
* significant medical disorder severe enough to require hospitalization within the 3 months prior to stroke,
* functional psychosis,
* absence of a caregiver (anyone living within a 30 minute drive who is available and willing to attend to patient),
* admitted from nursing home (since these patients are likely to return to the nursing home) and
* inability to speak English.
Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\&#39;s individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.


Eligibility Criteria:
Inclusion Criteria:

ASA I-III Laparoscopic abdominal surgery

Exclusion Criteria:

Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI\&gt;30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability
Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP

Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-\[18F\] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.

All patients with FUO and chronic inflammatory syndrome will undergo FDG-PET/CT and conventional morphologic imaging modalities. Results of these two diagnostic procedures in identifying diagnostic clues will be compared.

We assume FDG-PET/CT could be safer and more helpful to reach early final diagnosis in patients with FUO and chronic inflammatory syndrome than conventional morphologic imaging modalities

Eligibility Criteria:
Inclusion Criteria:

* Patient with FUO criteria:

Fever since 3 weeks, Temperature \> 38.3°C, No diagnostic after 3 days of hospitalization.

* Patient with periodic fever criteria:

Fever with criteria like FUO, Fever-free intervals, and apparent remission of the underlying disease, At least 3 febrile episodes.

* Inflammatory syndrome without any clinical sign, Important inflammatory syndrome: Erythrocyte sedimentation rate ≥ 50 at the first hour, and elevation of at least one another inflammatory parameter (haptoglobin, orosomucoïd, fibrinogen or C-reactive protein), Evolution since more than 3 weeks, No diagnostic orientation after clinical examination and history-taking, No diagnostic clue after 3 days of hospitalisation.
* Oral informed consent obtained.

Exclusion Criteria:

* Demented patient or unable to receive information on the protocol and to give informed consent.
* Pregnant women, or without contraception.
* Contraindication to iodine examination, gallium scintigraphy or 18FDG TEP-scan.
* Immunodeficient patient.
* Know HIV infection, neutropenic patient and nosocomial fever.
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission

One way to empower a community, in epidemic control issues, is to know the first-hand screening tools. There are no evaluations of these home-use tools from the perspective of patient and citizen empowerment and participation. The main objective of this study is to analyze whether a self-tracking and self-tracing tool, developed in a participatory way, increases the risk identification of the disease and the empowerment in terms of risk management of transmission by the participants.


Eligibility Criteria:
Inclusion Criteria:

Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group.

Exclusion Criteria:

Language barrier and other conditions that do not allow self-completion of the survey Be a COVID case or contact at the time of recruitment.
Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS

This study aims to evaluate the effect of a physical exercise intervention model on breast cancer survivors and their adherence. The sample will consist of 30 women with a primary diagnosis of breast cancer. The intervention will be carried out in a highly complex oncology center in Maceió-AL, Brazil, using the FITT components of the prescription: frequency (4 days a week), intensity (aerobic part through musical beats, subjective perception scale and resistance exercises through the number of maximum repetitions), the total time of each session will be 45 minutes. The intervention arms include combined exercise training and aerobic exercise (i.e., walking). Adherence to each intervention evaluated in the 12-week intervention cycle will be measured in each session.

The study participants will be enrolled in a visit to a group of psychologic therapy women cancer survivors who met monthly and who have submitted to breast cancer treatment in a hospital in the city of Maceió (AL), Brazil, classified as High Complexity Oncologic Clinic. At this visit, the proposal for physical exercises will be presented in the hospital area. Volunteers will be scheduled for an in-person visit and assessed for eligibility. Those who meet all the inclusion/exclusion criteria will be invited to integrate the physical exercise intervention.

The 12-week exercise intervention will consist of a combined exercise including an aerobic component (dance) and resistance training, and aerobic exercise (i.e., walking). Participants will be evaluated pre- and post-intervention in terms of several health indicators. All ethical approvals were collected before study initiation.

Eligibility Criteria:
Inclusion Criteria:

1. Women;
2. Adults;
3. confirmed diagnostic of breast cancer and with treatment completed (surgery, radiotherapy, or chemotherapy) within the previous six months.

Exclusion Criteria:

1. present metastatic breast cancer;
2. any clinical condition that would make participating in the exercise intervention impossible.
Continuous Glucose Monitoring for Women with Gestational Diabetes

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 14 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (\<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* Singleton pregnancy
* Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
* Needs to be able to understand and speak Dutch, French or English.
* Have email access

Exclusion Criteria:

* Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
* A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).
* Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
* Participation in an interventional Trial with an investigational medicinal product or device
* Multiple pregnancy
* History of bariatric surgery
* Known allergy to the adhesives used with the continuous glucose monitoring
Surgical Excision of the Fat Pad

Introduction:

The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located intra-articularly. Its function is not well known. During knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. Other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. This surgical step fat pad resection is a very small part of the whole total knee replacement procedure.

A previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (P = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening.

A randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. However this study did not evaluate the functional outcome in both groups.

To our knowledge, there are no RCT looking at the effect of the excision or preservation of the fat pad in TKR and the functional outcomes post operatively.

Study Hypothesis:

Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

RCT of excision or preservation of fat pad in TKR and the functional outcomes post operatively

Eligibility Criteria:
Inclusion Criteria:

* 1- Primary total knee replacement for knee osteoarthritis

Exclusion Criteria:

1. Revision Surgery.
2. Primary Knee Replacement for pathologies other than Osteoarthritis.
3. Previous knee fractures around the knee.
4. Previous confirmed intra-articular infections.
5. Non English speaking/reading patients.
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women
* Diagnosis of T1DM for a minimum of five (5) years
* Hypoglycemia unawareness or significant glycemic lability
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* History of islet cell, kidney, and/or pancreas transplant.
* Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
* Uncontrolled or untreated thyroid disease or adrenal insufficiency
* Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
* Non-compliance with current anti-diabetic regimen
* Detectable stimulated serum C-peptide during screening period assessment.
Perfusion Index Variability in Respiratory Distress Syndrome

Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.

Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.

Eligibility Criteria:
Inclusion Criteria:

* premature infants \< 32 weeks of gestational age

Exclusion Criteria:

* congenital malformation
* Apgar scores \<3 at 5 min
Prescription Audit in OPD of NABH & JCI Approved Hospital in Capital Territory of India

Aim of the study: The aim of the study is to evaluate the quality of the prescription provided to the outpatient.

Need of study:

For the promotion of the good clinical practice To improve the efficiency of the multidisciplinary team in the healthcare To utilize resources to provide better patient care To improve quality standards and quality of care For implication of professional practices To identify and eliminate deficient practice

Objectives:

1. To study the quality of good prescription
2. In minimization of prescription errors and medication errors
3. Also to comply with good clinical practice
4. Enhancement of patient safety
5. In the maintenance of rational prescribing
6. To study the quality of care provided by the hospital to the patient

Plan of study:

* To select the patient based on inclusion and exclusion criteria
* To collect the information from OP's prescription
* To identify prescribing errors and medication error
* To study the management of good prescription

Study Sites: Max Super Speciality Hospital, Saket, New Delhi (INDIA) Study Design: Observational cohort study Study Duration: 1 month (November 2022)

Source of the data: Review of out-patient prescription Sample size: 100 prescription

Possible outcomes:

Minimization of prescribing errors It improves the quality of care Enhancement of patient safety Compliance with good clinical practice In the maintenance of rational prescribing

Eligibility Criteria:
Inclusion Criteria:

* Participants who are willing to participate.
* Participants who are attending in the out-patient department.
* Participants reported during the study period.
* Participants who have a prescription which is legible and complete.

Exclusion Criteria:

* Participants who are unwilling to provide the required information.
* Participants who are not attending the out-patient department.
* Participants whose prescription is not legible and competent
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib


Eligibility Criteria:
Select Inclusion Criteria:

* Male or female patients ≥ 18 years of age with a confirmed diagnosis of Ph+ CML-CP and CCyR
* A suboptimal molecular response to imatinib defined as:

  * Group 1: Treated with 1 year of imatinib, complete cytogenetic response (CCyR) but no major molecular response (MMR) (Bcr-Abl levels \>0.1%IS);
  * Group 2: No specific duration of imatinib required, achieved CCyR but has \>1 log increase in Bcr-Abl transcript levels
* Adequate end organ function
* Patients must have had an imatinib washout period of at least 3 days and not to exceed 7 days prior to the first dose of nilotinib. Group 1 patients must have been treated with imatinib for at least 1 year. There was no imatinib treatment duration requirement for Group 2 patients.
* For Group 1, patients were eligible for screening if they were treated with an imatinib dose of at least 400mg daily. Dose reduction could have occurred as long as the minimum dose was 300mg daily and the reduction lasted ≤ 28 days. The patient was required to be on 400 mg daily (or a higher dose) of imatinib for at least 6 consecutive months leading up to screening for this study.
* For Group 2 patients, dose reduction while on imatinib could have occurred as long as the minimum dose was 300 mg daily, and the reduction lasted ≤28 days.

Select Exclusion Criteria:

* Prior accelerated phase or blast crisis CML
* Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study
* Previously documented T315I mutations
* Prior therapy with any other tyrosine kinase inhibitor except imatinib
* Patients with contraindications to receiving nilotinib, including concomitant medications