cyrilzakka/clinical-trials huggingface dataset:
Art Therapy in Progressive Supranuclear Palsy

Our aim is to study the effect of art therapy for people with PSP, with a focus on alleviating the symptoms associated with PSP, enhancing the overall quality of life for patients, and reducing caregiver stress. Overall, through our collaborative efforts on this study, we hope to unlock the benefits of art therapy for this vulnerable patient population, ultimately improving their overall well-being and enhancing their quality of life.

Progressive Supranuclear Palsy (PSP) is typically manifested by a multitude of distressing symptoms, including bradyphrenia and bradykinesia, speech dyspraxia, visual problems, and postural instability with high risk of falls. These symptoms not only inflict physical hardships on patients but also have profound emotional and psychological implications. Thus, a decline in self-esteem, a reduction in the quality of life, and heightened stress for caregivers is remarkable. In recent years, art therapy has garnered attention as a potentially effective intervention for individuals grappling with neurodegenerative disorders. Art therapy encompasses a wide array of activities that promote cognitive and motor skills, including shape recognition, motion perception, sensory-motor integration, abstraction, and eye-hand coordination. As a result, it holds promise as a therapeutic tool for addressing the intricate challenges faced by PSP people. Although art therapy has demonstrated positive outcomes in enhancing visual cognitive skills, refining visual exploration strategies, and bolstering general motor function in Parkinson's disease, its potential in the context of PSP remains largely unexplored. Given the unique symptomatology and emotional toll of PSP, patients suffering from this condition stand to benefit significantly from the healing and therapeutic effects of art therapy. In light of these considerations, our proposal aims to bridge this knowledge gap by implementing and rigorously studying the impact of art therapy on PSP patients. Our aim is to investigate the effect of art therapy for people with PSP, with a focus on alleviating the symptoms associated with PSP, enhancing the overall quality of life for patients, and reducing caregiver stress. Overall, through our collaborative efforts on this study, we hope to unlock the benefits of art therapy for this vulnerable patient population, ultimately improving their overall well-being and enhancing their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive supranuclear palsy
* Have the cognitive ability to provide informed consent

Exclusion Criteria:

* Primary neurological diagnosis other than progressive supranuclear palsy
* Cognition too impaired to provide informed consent
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg
* 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg

Exclusion Criteria:

* Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
* Patients with Type 1 diabetes mellitus
* Secondary hypertension of any etiology
* Other protocol-defined inclusion/exclusion criteria may apply
A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.

In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers.

Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance.

This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans.

The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks.

Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.


Eligibility Criteria:
Key inclusion criteria:

1. Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent.
2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening.
3. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests including inflammatory markers performed during the screening visit, as judged by the investigator
4. CYP2D6 phenotype:

   1. For Part A and Part B: ultra-rapid (from cohort A3 forward and B1 forward), normal or intermediate CYP2D6 function
   2. For Part C: CYP2D6 Poor Metaboliser function

Key exclusion criteria:

1. Any disorder/condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
2. Known history of histamine intolerance or severe anaphylactic reactions
3. Abnormal values at screening for any of the following laboratory parameters

   * Aspartate aminotransferase (AST) greater than Upper limit of normal (ULN)+10%.
   * Alanine aminotransferase (ALT) greater than ULN +10%.
   * Bilirubin (except if known Gilbert's syndrome) greater than ULN +10%.
   * Creatinine greater than ULN.

     a.eGFR below 90 ml/min/1.73m\^2
   * Glycated haemoglobin (HbA1c) greater than or equal to 5.7% (39 mmol/mol).
4. CYP2D6 unknown phenotype
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib

CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.

The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.

The study plan to enroll about 80 patients in 10 Italian centers:

Group A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)

Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).

Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of \>500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients with histological diagnosis of predominantly clear cell carcinoma
* Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
* Evaluable disease according to RECIST criteria v 1.1
* Treatment with cabozantinib after one or more previous therapies for mRCC
* Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months
* Any prognosis group according to the IMDC risk score
* Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.

Exclusion Criteria:

* Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
* Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
* Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm

An open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump.

background: The ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the physiologic function of the islet beta cells and freeing the patient from the need for constant calculations of daily insulin and carbohydrates. Several prototypes of closed-loop system have been developed in recent years, based on different types of control algorithms, to establish the connection between the sensor and the insulin pump. Current research in the formulation of this type of subcutaneous closed-loop system still faces major challenges, therefore, there is a need for further study and evaluation.

Objectives:

1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor
2. To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .
3. To evaluate real time sensor calibration algorithms based on the measured lag times
4. Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.
5. Developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes type 1 for at least one year.
2. ages \>10 years.
3. signed informed consent form.
4. willing to cooperate with all study requirements.

Exclusion Criteria:

1. Sensor allergy.
2. Psychiatrist diseases.
3. other chronic diseases.
4. Participation in another study that involves a medicine or a medical device.Subjects have to finish participating in other studies at least 30 days before joining this study. Each subject can participate in this study only once.
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).

A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years
2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
3. Healthy or medically stable participants
4. Contraceptive within 365 days post dosing

Exclusion Criteria:

1. Medical condition:

   * Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
   * Acute illness including fever on the day prior to or day of dosing.
   * Any other significant disease increase the risk to participant study.
2. Laboratory related:

   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) \> 1.5 × ULN, or TBL (total bilirubin) \> 1.5 × ULN (unless due to Gilbert's syndrome).
   * Serum creatinine \> 176 μmol/L.
   * Haemoglobin \< 10g/dL.
   * Platelet count \< 100 × 10\^3/μL.
   * White blood cell count \< 3.5 × 10\^3/μL or neutrophil count \< 1.5 × 10\^3/μL.
   * Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
3. COVID-19 infection history/any receipt of mAb indicated for COVID-19.
4. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).

The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult participants with select advanced solid tumor malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult participants with select advanced solid tumor malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult participants with CRC.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histologic documentation of advanced recurrent or metastatic cancer.
2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
3. Participants must have at least one lesion that is measurable by RECIST v1.1
4. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.

Exclusion Criteria

1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy.

After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment.

Study Hypothesis:

Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses:

Null Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.

Alternative Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.

Comparison(s):

In order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. Time-to-event data will be analysed using the log-rank test.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus
2. Aged 30-70 years of age
3. Hypertension at screening defined as:

   * an average cuff systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \>80 mmHg in untreated patients OR
   * patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension)
4. Overt nephropathy defined by 24 hour proteinuria \>= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)

Exclusion Criteria: None
Resource Availability Following Critical Illness

The purpose of this qualitative study is to explore the vital issues in recovery of QOL from the perspective of survivors of critical illness and understand these patients' views on rehabilitative services in the United States (U.S.). The theoretical framework for this study is Max Weber's Rational Choice Theory (RCT). The research questions will focus on understanding post-ICU QOL and the patients' experience with rehabilitative services following critical illness. A phenomenological study design is being employed, using semi-structured individual interviews with critical illness survivors. Data from the interviews will be coded for thematic analysis. The implications for social change include defining the meaning of QOL for an ICU survivor and improving healthcare policies for the therapies necessary to return survivors to a life worth living.

The purpose of this qualitative study is to understand the patient perception of QOL after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population.

The central research questions are:

RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative services after discharge?

Eligibility Criteria:
Inclusion Criteria:

* critical illness survivors within 18 months of ICU discharge
* minimum 48 hours of mechanical ventilation
* ability to read and understand English
* over the age of 18

Exclusion Criteria:

* emotional or psychological inability to participate in a 30-min interview
* not meeting inclusion criteria
HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)

The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.

HIV-1 is divided four distinct groups: M (major) which represents the pandemic strains while others groups O (outlier), N (non M, non O) and P are called non-M variants. Group O (HIV-O) is more divergent, endemic in Central Africa and Cameroon, where it represents about 1% of HIV infections. These variants are characterized by an important genetic divergence from pandemic HIV-1 group M (HIV-M), which impacts on the diagnosis, monitoring and treatment of infected patients. Although discovered in 1990, and emerged at the same time as HIV-M, no data of epidemiology, natural history and evolution of the genetic diversity of these variants is currently available. The few knowledge available to date come from sporadic cases, mainly through studies in Yaoundé. It is therefore essential to improve current knowledge on these variants and their consequences on infected patients.

The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.

Eligibility Criteria:
Inclusion Criteria:

* All available samples tested positive for HIV during the national Health survey of Cameroon in 2011 And 2018
* All Individuals who came to Centre Pasteur in Yaoundé or Garoua for HIV screening or viral load monitoring.

Exclusion Criteria:

* Insufficient quantity or degraded Dried Blood Spot samples
* All HIV-positive individuals aged less than 21 years, infected with a Group M HIV-1 virus, or those who refused to participate in the study
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients

This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).

Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.


Eligibility Criteria:
Inclusion criteria:

* male or female (of non-childbearing potential) between 18 - 70 years
* History of stable mild to moderate asthma
* non - smokers
* currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
* body weight \>50 kg with BMI 19-29.9 kg/m2
* normal ECG assessment

Exclusion criteria:

* history of significant disease
* history of life threatening asthma
* recent respiratory tract infection
* recent change of asthma medication
* treatment with high dose inhaled corticosteroids or oral corticosteroids
* recent participation in another trial
* history of drug or alcohol abuse
* known allergies (excluding asthma)
* recent blood donation
Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training

The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.


Eligibility Criteria:
Inclusion Criteria:

* unilateral stroke that verified by CT scan
* Time since stroke more than 6 months
* moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50
* Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands

Exclusion Criteria:

* serious visual or visual perception problems
* orthopedic or other neurological problems occurred in recent 6 months
* attend any other study in recent 3 months