cyrilzakka/clinical-trials huggingface dataset:
tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).

After unblinding, patients who received placebo treatment could be received active tDCS.


Eligibility Criteria:
Inclusion Criteria:

* National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
* CDR score ≤ 2
* treatment by IAChE ≥ 3 months
* MADRS score \< 18
* w/o severe progressive somatic pathology (especially tumor diseases)

Exclusion Criteria:

* last neuropsychological assessment \< 6 months
* presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program

Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis. Follow-up with patients will continue for a month after completion of the indicated scheme.

The objective of the study was to detect and analyze the adverse events presented during the administration of the drug doTBal® in patients of the Health Centers of the Ministry of Health of the municipalities of Colima, Tecomán and Manzanillo, of the State of Colima. All patients detected in the selected centers that are indicated treatment with doTBal® under the TAES (Strictly Supervised Shortened Treatment) regimen or who are already on this drug (according to their clinical record), will be asked to participate in the study explaining to them the same and requesting their informed consent in writing. In the case of minors, they will also be asked to provide their informed assent.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with a diagnosis of active pulmonary tuberculosis.
* Over 12 years old.
* Patients who are being treated with doTBal® under the TAES (Strictly Supervised Shorter Treatment) regimen.
* Informed consent (and in the case of minors informed consent) signed.

Exclusion Criteria:

* Withdrawal of informed consent.
Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients between 19 and 84 years
* patients receiving such an assembly in THA revision

Exclusion Criteria:

* \<19years
* \> 94 years
Adaptation and Validation of the Clinical Assessment Inventory for Eating Disorders (CIA)

The Clinical Impairment Assessment (CIA) assesses psychosocial impairment secondary to an eating disorder. The aim of this study was to create and validate a Spanish-language version of the CIA. Using a forward-backward translation methodology, we translated the CIA into Spanish and evaluated its psychometric characteristics in a clinical sample of 178 ED patients. Cronbach's alpha values, confirmatory factor analysis (CFA), and correlations between the CIA and the Eating Attitudes Test-12 and the Health-Related Quality of Life in ED-short form questionnaires evaluated the reliability, construct validity, and convergent validity, respectively. Known-groups validity was also studied comparing the CIA according to different groups; responsiveness was assessed by means of effect sizes.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients were eligible for the study if they had been diagnosed with anorexia nervosa, bulimia nervosa, or an eating disorder not otherwise specified (EDNOS) by psychiatrists based on criteria established in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (American Psychiatric Association, 1994), and provided written informed consent to participate.

Exclusion Criteria:

* Patients were excluded if they had a malignant, severe organic disease, could not complete the questionnaires because of language barriers, or did not give written informed consent to participate in the study.
Psychological Impact of Institutional Quarantine

Quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. However, it may create psychological, emotional, and financial problems for some persons. The experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched. In view of the increasing cases of COVID-19 in India and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. In India, no such study had been undertaken and our study thus filled the research gap. The cross-sectional observational study aims at assessing the psychological impact of quarantine on Indian BSF jawans (n=100). They would be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events Scale-Revised. A qualitative interview schedule will also be carried out. Data would be analysed.

Institutional quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. This may create psychological, emotional, and financial problems for some persons. The experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched.

In view of the increasing cases of COVID-19 in India and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. In India, no such study had been undertaken and our study would thus fill the research gap.

The cross-sectional observational study is aimed at assessing the psychological impact of quarantine on Indian Border Security Force (BSF) soldiers (n=100).

The participants will be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events Scale-Revised respectively. A qualitative interview schedule will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Indian-origin adults between the age of 18-60 yrs quarantined at border security force facility
* Both genders would be included

Exclusion Criteria:

* Any chronic co-morbid medical condition
* Current Diagnosis of COVID-19
Community Oral Nutrition Support Trial

The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes.

The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.

A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age \> 50 years
* At risk of malnutrition
* Competent to provide written informed consent and to answer questions
* Able to eat and drink
* Willingness to take part in the trial and to follow the trial protocol

Exclusion Criteria:

* Requirement for tube or parenteral nutrition
* Galactosemia
* Receiving current oral nutritional supplementation
* Palliative care
* Chronic renal disease requiring dialysis
* Liver failure
* Malignancy
* Participation in other studies
AZD2115 Multiple Ascending Dose Study

This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of first administration of the AZD2115 until 3 months after administration and must not donate sperm for 3 months after follow-up
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

  * Systolic BP \>140 mmHg
  * Diastolic BP \>90 mmHg
  * Heart rate \<40 or \>85 bpm
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* Serum potassium concentration of \< 3.80 mmol/L on admission (Day -1)
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
* History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg

The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma

Eligibility Criteria:
Inclusion Criteria:

* Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
* Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
* Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

Exclusion Criteria:

* Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
* Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Karnofsky performance status \> 70%
* Pathologic diagnosis of malignant pleural mesothelioma.
* Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon
* Negative serum pregnancy test in women of childbearing potential
* Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer
* Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer
* Adequate archival or fresh tissue for correlative analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible
* Absolute neutrophil count ≥ 1000/mcL
* Total bilirubin ≤ 1.5 mg/dl
* AST and ALT ≤ 3.0 x upper limit of normal
* Creatinine ≤ 1.5 x upper limit of normal
* Negative HIV serology blood test

Exclusion Criteria:

* Prior treatment with chemotherapy or immunotherapy for mesothelioma
* Autoimmune disease requiring systemic immune modulating treatment during the past two years
* Pregnant or lactating women
* Known active hepatitis B or hepatitis C
* Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid)
* Serious concurrent medical illness or another active cancer requiring treatment
* Active pneumonitis
A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* History of obstructive sleep apnea.
* Positive urine drug test.
Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study

This study will evaluate the efficacy and safety of TACE combined with atezolizumab + bevacizumab in the treatment of unresectable hepatocellular carcinoma, and the treatment patterns of the combination regimen

This study is a multi-center, retrospective and observational real-world study to explore the efficacy, safety and treatment pattern of TACE combined with Atezolizumab + Bevacizumab in unresectable hepatocellular carcinoma. The target population for the planned retrospective analysis of this project is patients who have been diagnosed with unresectable HCC according to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition) and treated with TACE combined with atezolizumab + bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

1. All patients were diagnosed with unresectable hepatocellular carcinoma according to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition);
2. Patients ≥ 18 years old, male or female;
3. Child-Pugh Class A and B liver function;
4. ECOG-PS score of 0 \~ 2 points;
5. Received TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.

Exclusion Criteria:

1. Other primary malignancies;
2. Incomplete data, such as no baseline image that can be assessed according to RECIST 1.1 or mRECIST, and survival outcome.
Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders

The purpose of this study is to determine if a manualised intervention to promote physical activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of everyday physical activity.

The Intervention program MoVo-LISA is a psychological intervention that should help participants to increase their level of physical activity for a healthy lifestyle.It contains three sessions (2 group,1 one on one) in the course of two weeks. The intervention focuses on planning and barrier management.

Participants develop activity ideas, goals and plans that enable them to integrate physical activity in their everyday routine and how to shield their motivation against barriers and difficulties.The intervention has proven to be effective with patients with pain disorders in rehabilitation.

This study examines if the intervention if effective for psychiatric outpatients as well. The intervention is compared to an active control group that receives a similar program that is focusing on a healthy diet.

Participants are recruited in the outpatient departements of three hospitals in Berlin and Brandenburg (Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy; St. Hewdig Hospital Berlin - Departement of Psychiatry; Oberhavel Hospital Brandenburg, Departement of Psychiatry) and at local psychiatrists in Berlin. Individuals are recruited by posters and flyers in the waiting areas areas or by information of their doctor. Patients can contact the researcher and are, after checked for eligibility, invited to an information event, where they get detailed information on the program and the study. After the information event, participants give written informed consent.

The intervention takes place in the outpatient departements of the three hospitals.

Clinical information about diagnoses, medication and functioning is obtained by their doctors by mail after the patients released them from confidentiality.

The study is an explorative approach to test if the program is suited for psychiatric patients. A sample size of 50 participants that complete the program is planned.

All data is collected pseudonymised to protect the identity of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of Age
* Patients in one of the psychiatric outpatients or at an local psychiatrist in Berlin
* Mental illness (ICD-10: F1-F4)
* No contraindications for physical activity
* Able to understand german language

Exclusion Criteria:

* Contraindications to physical activity
* Acute suicidality
Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE

The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical changes and inflammatory profile of normal eyes (matched for age, refraction and corneal thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for higher order aberrations.

iDesign is a promising new technique to treat myopia with astigmatism using ocular aberrations measured with a high resolution wavefront sensor.\[1,2\] Early studies with iDesign platform has established its safety and efficacy in correction of myopia with fewer patients reporting night vision problems.\[1,2\] In keratoconus, iDesign has also provided excellent outcomes following collagen crosslinking.3 SMILE is a recent technique that eliminates creation of flap and appears to achieve similar refractive outcomes as conventional LASIK but with less dryness, less inflammation and faster wound healing.\[4,5\] SMILE corrects lower order aberrations only.\[4,5\] Thus, a comparative assessment of iDesign and SMILE is necessary since iDesign can potentially give better visual outcomes with lower volume of tissue removal. If lower volume of tissue is removed, it is also hypothesized that the corneal would be more stable biomechanically.\[5\] Further, SMILE does not provide any correction of higher order aberrations. With the inclusion of higher order aberrations in the iDesign treatment plan, it is hypothesized that both short and long term outcomes will be better with iDesign than with SMILE.

Eligibility Criteria:
Inclusion Criteria:

1. Patients should be between 18 to 50 years of age.
2. Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction.
3. Patient must have a corrected distance visual acuity (CDVA) of 20/25 or better,
4. Patient must have a spherical equivalent refraction less than -10D
5. Patient must have refractive astigmatism less than 3D.

Exclusion Criteria:

1. Patient must not have a central corneal thickness (CCT) less than 480 micrometer
2. Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery
3. Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery.
4. Patient must not have an inter-ocular difference of more than 1.00 diopter (D) of spherical or 0.50 D of cylindrical refractive error.
5. Patient must not be on chronic systemic steroids or other medication that can affect wound healing.
6. Patient must not be allergic to primary or alternative medications.
7. Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation.