cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)

The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.

The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because most patients in the Western world present with advanced stages long term survival is found in about 25%, with local recurrences as part of treatment failure in up to 80% of cases. Studies examining the role of more extended lymph node dissections (D1 vs. D2), adjuvant radiotherapy or adjuvant chemotherapy did not result in a clinical relevant improvement of survival. In 2001 results of a South West Oncology group (SWOG) trial that randomized between surgery and surgery with chemoradiotherapy were published. This trial, that was hampered by suboptimal surgery (less than D1 in majority of patients) and radiotherapy (2D radiotherapy; 35% protocol deviations) showed an absolute increase in median survival of 9 months. More recently results of the MAGIC study, which randomized between surgery and surgery plus 6 perioperative courses of ECF chemotherapy, were presented. This regimen resulted in an absolute 5-year survival benefit of 13% and in a 10% higher resectability rate.

This phase III prospectively randomized study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in comparison with postoperative chemotherapy (3x ECC). Furthermore, toxicity of both treatment regimens will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in the stomach
* WHO \< 2
* Age ≥18 yrs
* Operable gastric cancer
* No prior abdominal radiotherapy or chemotherapy
* Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
* Start treatment within 10 working days after registration
* Written informed consent

Exclusion Criteria:

* T1N0 disease (endoscopic ultrasound)
* Distant metastases
* Inoperable patients; due to technical surgery-related factors or general condition
* Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri.
* Solitary functioning kidney that will be within the radiation field
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
* Uncontrolled (bacterial) infections
* Significant cardiac disorders
* Continuous use of immunosuppressive agents
* Concurrent use of the antiviral agent sorivudine or chemically related analogues
* Hearing loss \> CTC grade 1
* Neurotoxicity \> CTC grade 1
Adaptations to 4-s Sprint Interval Training at Different Intensities

The purpose of this study is to investigate the chronic effects (i.e., 8 weeks, 3 times per week) of training at 50% and 75% of maximal power with 4-s sprint interval training on physiological adaptations. We previously examined the effect of training with an all-out intensity (i.e., 100% of maximal power) and reported increases in cardiorespiratory fitness. Now, we propose to examine the effects of a lower exercise intensity domains on cardiovascular fitness and its ability to stimulate the cardiorespiratory system. We hypothesize that training at 50% and 75% of maximal power will improve cardiorespiratory fitness similar to our previous findings while reducing the rate of perceived exertion during the exercise session. It is anticipated that the group engaged in training at 75% of maximal power will experience greater improvements in comparison to the group training at 50%.

Background Sprint interval training (SIT) is a well-established method for improving cardiovascular and anaerobic performance. While most research focuses on all-out efforts, less is known about the effects of submaximal sprint intensities on these adaptations. This study examined how training at 50%, 75%, and all-out (85%) of maximal anaerobic power (Pmax) influences aerobic capacity and anaerobic power over an 8-week training period.

Methods

Participants: 24 recreationally active adults (12 females, 12 males) were randomly assigned to one of three training groups:

50% Pmax

75% Pmax

All-out (85% Pmax)

Training Protocol: Participants completed three sessions per week for eight weeks. Each session consisted of thirty 4-second sprints on a cycling ergometer, totaling 10 minutes per session.

Measurements: Peak oxygen consumption (VO₂peak) and maximal anaerobic power (Pmax) were assessed before and after the training program.

Eligibility Criteria:
Inclusion Criteria:

* Young (18-30),
* Healthy,
* Recreationally active, but untrained (not meeting ACSM's recommendations of 150 min/week of moderate-vigorous aerobic exercise)

Exclusion Criteria:

* Cardiovascular disease
* Smoking
* Subjects who were exercising regularly (\>75 min/week) were excluded.
Informing Low-acuity Emergency Department Patients of Non-emergent Resources

The goal of this campaign is to reduce unnecessary visits to a Geisinger emergency department (ED)/encourage patients with high acuity visits to follow up with an appropriate Geisinger provider. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will includecalls to action to see their Geisinger CMSL PCP either in person or virtually. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients follow through on the message-specific calls to action in the messages differently across conditions.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Geisinger ED visit rated as low acuity (L4 or L5)
* Discharged from Geisinger ED in past 24 hours

Exclusion Criteria:

* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the EHR or because the patient opted out
* Admitted to hospital
* Already included in intervention in past 365 days
Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique

Awareness during general anesthesia - that has an incidence between 0.1% and 0.9% of cases and may be more in elderly - remains a concern for anesthesiologists. Awareness experiences range from isolated auditory perceptions to reports of a patient being fully awake, immobilized, and in pain. The isolated forearm technique allows assessment of consciousness of the external world (connected consciousness) through a verbal command to move the hand (of a tourniquet-isolated arm) during intended general anesthesia.

Objective: To compare inhalational induction versus intravenous induction regarding awareness during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* 50 American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
* aged 60 to 80 years,
* 70-80 kg,
* both sexes,
* with intact hearing,
* undergoing elective day case surgery were included in the study.

Exclusion Criteria:

1. Uncooperative patients,
2. Language barrier problems,
3. Psychological disorders,
4. Suspected difficult intubation,
5. History of awareness under anesthesia,
6. History of substance abuse,
7. The inability to have tourniquet on arm for the IFT (e.g., lymphedema or operative site)
8. Neuromuscular disorders.
9. Advanced renal, hepatic, cardiac, respiratory or neurological dysfunction
10. If rapid sequence induction was indicated (not suitable for inhalation induction).
Comparative Intervention Study of Stress Reduction in Corporate Health Management

Aim of the study is the evaluation of the effects (psychological and physiological) of an hrv-biofeedback training, a mindfulness training and a combination of both training methods for stress reduction.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Working in the business in which the study is conducted

Exclusion Criteria:

* Cardiac disease
* Thyroid disease (intake of glucocorticoids)
* Actual psychological illness
* Intake of psychotropic drugs
* Intake of other medication changing HRV
Foot Muscle Strengthening Exercises for Pes Planovalgus

Pes planovalgus is a common foot condition affecting the child population. It is characterized by the partial or complete collapse of the medial longitudinal arch with rearfoot eversion and forefoot abduction, which is associated with changes in lower extremity kinematics during dynamic activity.

The lower extremity chain includes the foot, ankle, knee, and hip joints, with the feet acting as the base of support. However, due to their small size, maintaining balance can be challenging. Any small dynamic change in the foot, as the support base, can impact overall body posture. The foot arch, which can be pronated or supinated, affects proprioceptive input by altering joint movement, contact area, and muscle strategy for stability. Pes planovalgus, characterized by excessive subtalar pronation, lead to instability and hypermobility, requiring more neuromuscular control to maintain balance. As a result, flat feet can cause pathomechanical issues and compensatory actions in the lower extremity chain, affecting overall body balance.

The effectiveness of exercise interventions, particularly foot intrinsic muscle strengthening exercises, in increasing the medial longitudinal arch in individuals with pes planus has been investigated in numerous studies. It is widely accepted that both intrinsic and extrinsic muscle groups play a crucial role in the formation, maintenance, and enhancement of foot arches. However, there is a lack of studies specifically examining the effectiveness of exercises aimed at strengthening these muscles in children with pes planovalgus. Therefore, the purpose of this study is to compare the effects of two corrective exercise programs focused on the improvement of the medial longitudinal arch in children with pes planovalgus: one incorporating routine intrinsic muscle exercises and the other combining them with extrinsic muscle exercises.

Voluntary children who have been diagnosed with pes planovalgus will be included in the study. Signed voluntary consent will be obtained from caregivers. Participants will be divided into two groups. Study groups will be as follows: a) Intervention Group (Intrinsic\&Extrinsic Exercise), b) Control Group (Intrinsic Exercise).

Eligibility Criteria:
Inclusion Criteria:

* Presence of bilateral pes planovalgus,
* Being between 4-7 years of age,
* Having a body mass index within normal limits

Exclusion Criteria:

* Having high femoral anteversion, internal tibial torsion and metatarsus adductus
* Having leg length inequality
* Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
* Having a history of pain, deformity or surgery related to the vertebral column and lower extremities
* Having a cognitive, mental or serious psychiatric disease
* Having been involved in any exercise program or sports activity in the last six months
French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.

Diagnostic and therapeutic digestive endoscopy has been booming over the last 10 years. Many new techniques in digestive tract or hepato-bilio-pancreatic endoscopy are introduced every year. France is the Western country with the most technical skills in terms of the number of experts relative to the size of its territory, but is lagging far behind in terms of the promotion and reimbursement of these techniques by health insurance funds. France is also experiencing difficulties in centralizing health data from the thousands of endoscopies performed in the country every year. Pooling this data across the country, following the example of certain European and international partners (the Dutch, English and Australians), would make it easier to exploit data from innovative, sometimes rare or confidential digestive endoscopy procedures, and to justify their reimbursement once their usefulness has been confirmed through large-scale descriptive prospective studies associated with national multicenter publications.

The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practi

Eligibility Criteria:
Inclusion Criteria:

* Patients \&gt; 18 yo
* Patient able to give consent
* Patient with innovative endoscopy

Exclusion Criteria:

* Opposition to participation in the present project to be notified in the file
* Patient under court protection
Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic tinnitus
* Chronic subjective tinnitus for more than 6 months
* Subject is naive regarding rTMS
* Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
* Stable enough to complete this study per the opinion of the Study Physician
* No restrictions, provided the dosages have been in place for at least 3 months
* A three month washout from any other tinnitus treatment or management program is required prior to entering this study.

Exclusion Criteria:

* Objective tinnitus or tinnitus with treatable cause
* Presence of intracranial or intraocular ferromagnetic materiel or particles
* Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
* Personal history of central nervous system disorder, head injury, stroke or seizures
* Familial history of epilepsy
* Concomitant medication with antidepressants and antipsychotics
* Pregnant women
* Others known contraindications to rTMS or brain MRI
Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.

One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (\<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.

The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older.
* with or without a history of stone disease.

Exclusion Criteria:

* They are unable to take any of the medications due to health reasons.
* Participants are pregnant or nursing.
* Participants are unable to adhere to the metabolic diet.
* Participants had a prior adverse event from one or more of the medications.
Lower Extremity Evaluation in Children With Diparetic Cerebral Palsy According to ICF Perspective

Cerebral palsy (CP); is the most common neurodevelopmental disorder seen in childhood, characterized by permanent motor dysfunctions that develop due to brain damage occurring before birth, during birth, or in early childhood.

The most common type is spastic type CP with a prevalence rate of 70-80%. Spastic type CP is divided into three groups as diparetic (38%), hemiparetic (39%) and quadriparetic (23%). In diparetic cerebral palsy (DCP); lower extremity involvement is more pronounced than upper extremity involvement. Typically; weakness in the trunk, postural and antigravity muscles, functional and/or structural asymmetry between both lower extremities are seen and this condition is closely related to impaired static and/or dynamic balance, decreased postural control, decreased functional performance, and low participation rate in activities.

The ICF (International Classification of Functioning, Disability, and Health) was developed by the World Health Organization in 2001 and is a comprehensive model that evaluates health status not only through the presence of diseases and disorders but also through various dimensions such as functionality, environmental, and personal factors. The ICF model includes five main components to evaluate an individual's functionality and disability: body structure and functions, activity, participation, environmental and personal factors. In recent years, functional abilities, including social participation, have increasingly become the focus of research in children with CP.

It's an observational study.

Purpose of the study: The increase in tone seen in the lower extremities in children with diparetic cerebral palsy (DCP) may adversely affect the activity and participation of children. Our study aim is to evaluate lower extremities in children with DCP according to ICF perspective.

A total of 30 cases, 15 females (50%) and 15 males (50%), aged between 3 and 13 years (mean: 5.8), who were admitted to the Pediatric Rehabilitation Department of Acıbadem Altunizade Hospital with the diagnosis of DCP between 2019 and 2022, were included in this cross-sectional study.

* What should the rehabilitation program for children with DCP include?
* What should we consider when evaluating children with DCP?

The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity, and Pediatric Functional Independence Measure (WeeFIM) was used for participation

Eligibility Criteria:
Inclusion Criteria:

* Between 3-13 years old,
* Diagnosis of diparetic cerebral palsy,
* Participants and/or parents willing to participate in the study voluntarily.

Exclusion Criteria:

* Having different types of CP such as dyskinetic, mixed, ataxic types other than spastic type,
* Having spastic quadriparetic or hemiparetic type CP,
* Having received Botulinum Toxin injections to the lower extremities within the last 6 months.
Effect of Epidural Analgesia on the Parameter ANI During Childbirth

There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).

Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years,
* ASA I or II,
* No history of cardiovascular or respiratory disease
* No cardiovascular medication
* No treatment with a tocolytic agent(salbutamol, nicardipine)
* Desiring epidural analgesia at the early phase of labor pain

Exclusion Criteria:

* Too fast labour
* A pain score at or above 70 on the pain scale
* A disturbed EKG signal or extrasystoles
* Pace-Maker
* Diabetes mellitus