cyrilzakka/clinical-trials huggingface dataset:
Effects of a Multimodal Physical Exercise and Functional Rehabilitation Program on Fatigue, Pain, Functional Capacity and Quality of Life in Cancer Patients With Tumor Asthenia.

Tumor asthenia is the most common symptom associated with cancer and its treatment. Although the estimated prevalence varies between 60-90%, and it is considered the longest-lasting symptom in cancer patients, having the greatest impact on quality of life parameters, it is a problem that is still undervalued in general by health professionals . It has been observed that individuals with this process find it difficult to normalize their daily life, either due to a deterioration in their clinical condition or due to a problem in the generalization of what they have learned during their hospital stay. That is why we plan to carry out a clinical trial, to evaluate the effect of a controlled patient follow-up program, and thus be able to address these difficulties in the most optimal way. A randomized clinical trial of two parallel groups will be carried out, belonging to the oncology service of the University Hospital of Salamanca. 44 participants with tumor asthenia, who are admitted at the time of inclusion, will be selected through a consecutive sampling. After the baseline evaluation, the participants will be randomized into two groups. The subjects of the experimental group will carry out a Functional Rehabilitation Program, with a duration of one month. The main variable will be the evaluation of the basic activities of daily life (Barthel scale). The secondary variables will be oriented to evaluate the change in tumor asthenia, attention and cognitive functions, parameters of quality of life, pain, functional capacity and body composition. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with tumor asthenia.


Eligibility Criteria:
Inclusion criteria:

* Having among the reasons for admission a pathological diagnosis of newly diagnosed or relapsed oncological disease.
* Being admitted to the Oncology Service of the Salamanca University Hospital.
* Barthel index score between 15 and 55 points.
* Level of tumor asthenia greater than or equal to 4 on the EVA scale for tumor asthenia.
* Sign an informed consent in which they authorize their voluntary participation in the study (Annex II).

Exclusion criteria:

* Present cognitive impairment assessed with the Mini-mental State Examination (MMSE) less than 24 points.
* Present hemoglobin levels below 10g / dl.

Withdrawal criteria:

* Exitus of the patient.
* Progression of the disease leading to a terminal state.
* Hospitalization of the patient at the time of home monitoring.
* Do not carry out Final Assessment.
Assessment of CAI in Adults With PWS.

Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI) in adult patients with Prader Willi Syndrome (PWS) remains unclear.

Aim: To assess the prevalence of CAI in adults with PWS and to analyse the effects of replacement therapy with hydrocortisone (HCT) in patients with suspected CAI.

Material and Methods: Twenty one adult patients with PWS were evaluated. Based on peak cortisol at the 30 minute of the high dose short Synacthen test (HDSST), patients were divided into three groups: CAI (central adrenal insufficiency) - peak cortisol \<500nmol/L, intermediate (partial AI) - peak cortisol ≥500 nmol/L and \<600 nmol/L and AS (adrenal sufficiency) - peak cortisol ≥ 600 nmol/L. In patients with diagnosed CAI HCT replacement treatment was initiated. Body weight, body fat percentage, signs, and symptoms of CAI were evaluated after 6 and 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* PWS
* age \>=18 years

Exclusion Criteria:

* age \<18 years
* GC treatment at last 6 months
To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.

Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastric cancer with a single non-curable factor
* A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.

Exclusion Criteria:

* Patients who can have radical resection.
* Patietns who have more than one metastasis.
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf. Centers that are providing medical care for kidney transplant patients who may convert patients from tacrolimus BD to Advagraf will be identified and requested to approach patients for consent to participate.

Eligibility Criteria:
Inclusion Criteria:

* Adult kidney transplant patients who are on tacrolimus BD and identified for conversion to Advagraf. Patients will only be approached about participating in the registry after their physician has made the decision to convert them to Advagraf. Patients previously treated with Advagraf and who have stopped for any reason will not be excluded from the registry provided that the physician has decided to convert.

Exclusion Criteria:

* Patients currently taking Advagraf treatment
Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma

The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment.

The secondary objectives of the study are:

* To evaluate the safety profile of AVE1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity.
* To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or any PK interactions when given in combination with other anti-cancer therapies.
* To assess the preliminary clinical activity in terms of response rate (Complete response + Partial response), duration of responses, stabilisation rate and duration of stabilisation, according to RECIST criteria.
* To assess the biological activity at the tumor level.

AVE1642 will be administered as an IV infusion on day 1 and then every 3 weeks for at least 2 infusions for evaluability requirements. Curative and / or prophylactic management of allergic reactions during infusion will be implemented when needed. The duration of the study for one patient will include a period for inclusion of up to 2 weeks, at least 2 cycles of treatment in dose escalation step (one cycle of AVE1642 alone and at least one cycle of AVE1642 in combination) and at least one cycle of the combination in the extension cohort, followed, when possible, by a minimum of 30-day follow-up after the last drug administration, in order to detect any potential immunogenicity. In the second step, the patients will continue treatment until disease progression, unacceptable toxicity or willingness to stop.

The expected enrolment period is 15 months with at least 30 day follow-up after the last patient treated.

Eligibility Criteria:
Inclusion Criteria:

* Patients not eligible for surgical resection, liver transplantation, local ablation techniques or chemoembolisation and with histologically proven liver carcinoma whenever possible or combination of radiologically documented hypervascular liver tumour and α foeto protein level ≥ 400 ng/ml
* Signed and dated approved patient informed consent form prior to enrollment into the study

Exclusion Criteria:

* ECOG performance status \> 2
* Inadequate organ function:

  * Neutrophils (ANC) \< 1,500/mm3
  * Hemoglobin \< 10g/dl
  * Platelets \< 100,000/mm3
  * Total bilirubin \> 1.5 x ULN
  * ASAT, ALAT \> 3 x ULN
  * Creatininemia \> 1.5 x ULN (or ≥ 2.0 mg/dl)
  * INR \> 1.6
  * Liver cirrhosis Child Pugh B or C (score \> 6)
  * HbA1C \> 8%
* No measurable or evaluable tumoral lesion
* Patients not eligible for sorafenib therapy and for whom this therapy cannot be postponed by 3 weeks (during AVE1642 single treatment period) in dose escalation part
* Prior exposure to an anti-IGF-1R class compound

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Obstructive Sleep Apnea Syndrome and Attention Executive Function Disturbances

Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. However the correlation between the severity of obstructive sleep apnea and the degree of cognitive dysfunction was not demonstrated. Our hypothesis is that patients suffering from a more severe sleep apnea will demonstrate a greater degree of cognitive dysfunction.

Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. However the correlation between the severity of sleep disturbances and the degree of cognitive dysfunction was not demonstrated.We intend to study 80 patients with various degrees of obstructive sleep apnea. All patients will undergo executive cognitive tests as well as tests to assess for levels of depression, anxiety and attention.

Eligibility Criteria:
Inclusion Criteria:

1. Apnea hypopnea index\>5
2. Age 20 - 70 years

Exclusion Criteria:

1. Pregnant women
2. Known chronic cardiovascular or pulmonary disease
3. Patients s/p CVA or brain damage
4. Known depression or other psychiatric disorder
5. Patients with severe cognitive dysfunction (MMSE\<25)
6. Patients receiving stimulants, antipsychotic or anti-depression medications
WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).

Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (aged 65 - 85 years inclusive) diagnosed with probable Alzheimer's disease dementia .
* Willing and able to comply with study requirements.
* Have a study partner who sees the participant for more than three hours a day, 5x per week and is that is willing to consent and participate in the trial.
* Anticipation that the participant is able to remain on a stable regimen of medications used for the management of Alzheimer's disease and will not introduce new medications used to treat Alzheimer's disease during the study.
* Participant and study partner must both be fully vaccinated from COVID-19 prior to the study screen

Exclusion Criteria:

* Were diagnosed with probable Alzheimer's disease prior to 65 years of age.
* Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months.
* Are being treated with another neurostimulation device
* Experience frequent falls
* Works night shifts.
* Have unresolved complications from a previous surgical procedure at the baseline visit, such as swelling or persistent pain, that requires medical intervention.
* Have active ear infections, or other significant ear problems.
* Have a recent history of frequent ear infections
* Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment.
* Have chronic tinnitus.
* Have previously been diagnosed with traumatic brain injury with ongoing sequela.
* History of medication-refractory depression or bipolar disorder in the past three years.
* History of schizophrenia.
* Participation in an interventional clinical trial for any medical or psychiatric indications within 3 months of the screening visit, or at any time during the study.
New Ways to Help Patients Improve Their Diabetes Control

The percent of glycosylated hemoglobin, also known as a hemoglobin A1C value, is the standard way that clinicians assess a patient's diabetes control. Numerous studies have shown that maintaining a hemoglobin A1C value less than 7% is associated with lower rates of diabetes-related complications. Clinicians use this value to determine whether a patient with diabetes requires changes in their disease management. The main problem with this practice is that many patients do not understand what this number means. The goal of this project is to examine ways to make feedback about glycemic control easier for patients to understand. The hope is that improved patient understanding will result in an improvement in diabetic control and thus a reduction in disease-associated complications. Patients with a diagnosis of diabetes and a hemoglobin A1C value greater than 8% within the preceding three months will be eligible for the study. Pregnant women will be excluded. Given the nature of the intervention we will also exclude patients with cognitive deficits. In this study, patients will be randomized to three groups. The first group with be told their HgbA1C value only, the second group will be told a letter grade interpretation of that value, and the third group will be shown a face. The face emotions will range from happy to sad reflecting the level of control. The main outcome will be trend in hemoglobin A1C values over time. Secondary outcomes will include patient understanding of disease state and the number of hemoglobin A1C values checked following the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18 with diabetes mellitus listed as a problem list or in their past medical history on their electronic medical record who have a hemoglobin A1C value greater than 8% within three months of study enrollment.

Exclusion Criteria:

1. Pregnant patients
2. Illiterate patients
3. Patients with known cognitive deficits affecting ability to participate in study
4. Any current participants in another active research study
Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease

Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to, and has provided written Informed Consent prior to any study related procedure.
* Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
* Willing and able to take oral medication and able to comply with the study specific procedures.
* Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.
* Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
* Newly instigated or changed treatment with neuroleptics/antipsychotics
* Use of tricyclic antidepressants or class I \& III antiarrhythmics at any time during the study period.
* Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
* Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
* Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
* Females who are pregnant or lactating.
* Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
* Known allergy to any ingredients of the trial medication.

  * Additional criteria apply, please contact the investigator for more information
Sensory Training for Orientation and Balance

This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. The researchers will use the new tests and treatments with adults who are affected by visually-induced dizziness. Testing is done twice before and once after treatment. The total time participants are involved in the study is approximately two weeks.

This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. It is not known whether the new tests of orientation and balance are better, worse, or the same as existing tests in the ability to detect problems, nor is it known if the new treatment technique is any better, worse, or the same as existing treatments for dizziness and imbalance. However, the researchers hypothesize that the new tests will improve the ability to detect problems. They hypothesize that the treatment will result in less dizziness, better balance, and reduced risk of falling for those who receive it and that it is a better alternative to treatments that are already available to patients.

In order to see if this is true, the researchers will use the new tests and treatments with adults who are affected by dizziness. All participants in this study will undergo the same tests and will receive the same treatment. Testing is done twice before and once after the treatment period. The tests and treatment are done while standing on a computerized platform that measures balance and can tilt people from side to side. During these study procedures, participants wear virtual reality goggles that show them simple images in an otherwise dark environment.

The goal of the tests and the treatment is for participants to use what they feel to help them decide if the images shown inside the goggles are aligned with the person's sense of gravity. Participation in this study is voluntary and people who decide to participate may stop at any time without penalty.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have self-reported symptoms of visually-induced dizziness
* Participants must have normal self-reported cognitive function
* Participants must speak English fluently
* Weigh less than 225 pounds
* Be able to support their body weight in an upright posture for 15 minutes at a time
* Be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in the study protocol.

Exclusion Criteria:

* Participants must not be participating in vestibular and balance rehabilitation therapy
* Pregnant or planning to become pregnant while in "on study" status
* Best-corrected visual acuity \> 20/70
* Any self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
* Peripheral neuropathy
* Self-reported history of frequent syncope (\>1/month).
CORNEAL EPITHELIAL MAPPING IN DIABETICS

The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.

The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.

Eligibility Criteria:
Inclusion Criteria:

1. The patients aged between 40- 60 years old of both genders.
2. The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
3. The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
4. The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)

Exclusion Criteria:

1. Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
2. Ocular surface disorders (e.g. dry eye) or any corneal pathology.
3. Corneal scars or epithelial dystrophies.
4. Use of any topical medications.
5. Elevated IOP, pregnancy or lactation.