cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL /min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria in urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactating patients;
* Participation in clinical trial in the year prior to this study.
The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire

Effect of supervision on scoring and completion on Quality of Life Questionnaire

This protocol will study the impact of supervision on completion and scoring of sensitives domains of QoL Questionnaires and QoL Questionnaires in general in a multi-center, randomized, cross-over design in cancer patients receiving systemic antineoplastic therapy

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥18 years of age and legally competent
* Signed informed consent available
* Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)
* Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval
* Patient is ready and able to complete quality of life questionnaires in German (on paper

Exclusion Criteria:

* One or more of the inclusion criteria not met.
Effects of Regular Exercise on Sensory-motor Functions and Fall Risk in the Elderly

Falls in elderly population are an important public health problem. The aim of this study is to examine the vibration, proprioception, muscle strength, static balance, reaction time and postural stability parameters of female individuals aged 65 and over who exercise regularly by comparing them with sedentary female individuals in the same age group and to determine the effect rates of these parameters on fall risk. A total of 92 individuals will evaluate in the study, including 46 participants who perform regular exercise and 46 participants with a sedentary lifestyle. Participants who performs regular exercise will determine among individuals who going to participate in a combined exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks. The socio-demographic characteristics, health conditions and exercise habits of the participants will be recorded. For evaluating the physical activity levels of the participants, the International Physical Activity Questionnaire-short form (IPAQ-SF); for vibration sense evaluation, 128-Hz frequency tuning fork; for the evaluation of proprioception sense, angle repetition test; for the isometric muscle strength assessment, digital hand dynamometer; for static balance evaluation, standing stork balance test; for reaction time evaluation, MoART measuring device; for postural stability evaluation, PROKIN-PK200W\* (Tecnobody, Italy) device and for fall risk assessment, Morse fall scale and MAHC-10 fall questionnaire will be used.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals with an International Physical Activity Questionnaire (IPAQ) score of \<600 (for control group)
* Individuals who will be participated in an eight-week regular exercise program (for the exercise group)
* Those who scored 24 or higher on the standardized Mini-Mental State Examination, individuals without communication problems, and those who were not bedridden or wheelchair-bound.

Exclusion Criteria:

* Individuals who had received any diagnosis/treatment for spinal or lower extremity problems or had undergone surgery within the last six months, as well as those with severe chronic illnesses or uncontrolled conditions (e.g., hypertension, cancer), will be excluded from the study.
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a waiting time of four months. Participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al. (1999) Behavior Therapy 30: 597-605) for three weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clear memory of an "index" traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (Montgomery and Bech 2000)
* PTSD according to the DSM-IV, related to the index traumatic event, as measured with the CAPS: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50
* Not receiving other psychotherapy for PTSD during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed
* If on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial
* Aged between 18 and 70 years
* Sufficient proficiency in the German language to participate in BEP
* Consent to be randomized into the trial

Exclusion Criteria:

* Current psychotic, bipolar, substance-related, or severe personality disorder
* Current severe depressive disorder
* Severe cognitive impairment or a history of organic mental disorder
* Evidence of PTSD or depression immediately prior to the index trauma
* Ongoing threat of traumatic exposure
* Prominent current suicidal or homicidal ideation
* Asylum seeking status
Early Detection of Children With Developmental Disabilities in Assiut Governorate

The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years).

A group of twenty-one licensed nurses with professional experience ranging from 5 to 11 years participated in the study. The participants completed the measurements to evaluate their current knowledge, practice, and perception pre-, post-, and follow-up of the training program in relation to the early detection of disabilities.

Eligibility Criteria:
Inclusion Criteria:

* The study was conducted in selected health units in Assiut, an Upper Egypt Governorate, in selected villages:

  * far from the main government services,
  * without access to public or subsidized transportation to and from the selected villages, and
  * without the presence of any allied health professionals (physical therapists, occupational therapists, speech and language therapists, psychologists), who do not offer any of these medical services.

The selected nurses should be

* employed by the village health department in the public sector,
* locals of the village where the health unit is located,
* and untrained in the early identification or examination of disabled children.

Exclusion Criteria:

* other than inclusion criteria
Long-term Impact of Infection With Novel Coronavirus (COVID-19)

LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.

LIINC is an observational, prospective study of individuals previously infected with SARS-CoV-2 who have recovered from acute illness. The overall objective of the study is to investigate the clinical consequences of SARS-CoV-2 infection. These include the pre-existence and development of medical conditions, measures of immune activation and inflammation, changes in immunologic function, and variability in host responses. There will be a specific focus on demographic differences including age, gender, and race.

Enrolled volunteers are seen at San Francisco General Hospital at baseline, monthly for 3 months and then every 3 months for up to 2 years. Visits include a detailed interview, saliva collection, and a blood draw. Baseline visits take approximately 90 minutes, and follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent, and
2. Age \>/= 18 years, and
3. A history of SARS-CoV-2 infection, as evidenced by:

   1. Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or
   2. Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,
4. And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier.

Exclusion Criteria:

1. Self-reported or documented chronic anemia with hemoglobin \< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
2. Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
3. Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements or to give informed consent.
Natural History Study of Fungal Infections of the Blood in Patients With Cancer or in Patients Who Have Undergone a Stem Cell Transplant

RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.

PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.

OBJECTIVES:

* Determine the incidence of fungemia in relation to the number of admissions to the hospital in patients with solid tumor or hematologic malignancy or in patients who have undergone hematopoietic stem cell transplantation.
* Determine the fungal species distribution, prognostic factors for outcome, and crude and attributable mortality in patients also diagnosed with fungemia.

OUTLINE: This is a multicenter, nonrandomized, prospective study.

* Group A (no documented fungemia at study entry): Data regarding the number of patients with cancer or who have undergone hematopoietic stem cell transplantation, including those who develop documented fungemia, who are admitted to the hospital is collected for 2 years.
* Group B (documented fungemia at study entry): Fungal strains isolated from the initial positive blood culture are collected and undergo examination, including confirmation of species identification, susceptibility testing, and/or minimum inhibitory concentration determination. Data, including antifungal treatment, clinical and microbiological response to antifungal treatment (at 2, 4, and 12 weeks after diagnosis), and survival status, is collected for each documented fungemia episode\* for up to 12 weeks after diagnosis of fungemia.

NOTE: \*That occurs within a 2-year period.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Group A:

  * Meets any of the following criteria:

    * Diagnosis of hematological malignancy including, but not limited to, any of the following:

      * Acute lymphoblastic leukemia
      * Acute myeloid leukemia
      * Myelodysplastic syndromes
      * Chronic lymphocytic leukemia
    * Diagnosis of solid tumor, including, but not limited to, any of the following:

      * Breast cancer (hormone receptor status not specified)
      * Lung cancer
      * Colon cancer
    * Recipient of a hematopoietic stem cell transplantation, including, but not limited to, any of the following:

      * Allogeneic or autologous bone marrow transplantation
      * Peripheral blood stem cell transplantation
  * Admitted to a participating hospital ward (defined as ≥ 1 overnight stay)
* Group B:

  * Meets the same criteria as in group A
  * Positive blood culture for a fungus

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior participation in this study
Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis

The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.

In the present study, 60 healthy patients \> 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.

Eligibility Criteria:
Inclusion Criteria:

Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;

* With a partially or completely disintegrated blood clot in the socket
* With exposed bone that gives a dark gray appearance
* With bad odor

Exclusion Criteria:

* Who does not want to be volunteer for the study,
* Smokers,
* During pregnancy or lactation,
* Has a chronic systemic disorder that will affect recovery,
* Has hematological disorder
* Cooperation cannot be established,
* Previously received radiotherapy or chemotherapy,
* Patients using oral contraceptives
Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.

* To evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort.
* To evaluate the role of drug metabolism and DNA repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality.
* To identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (MRD) and mortality.
* Evaluate family functioning, psychosocial wellbeing, and financial toxicity.

OUTLINE: This is an observational study.

Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.

Eligibility Criteria:
Patients at any age with a history of sarcoma, with or without evidence of a persistent disease

• For pediatric patients

* Parent/primary caregiver of patient
* Sibling of patient aged 8 years or older
The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear

The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.

In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Being between 40-65 years old
* Having been diagnosed with partial RM rupture
* RM rupture in MRI image
* At least 3 ATNs in the shoulder complex
* Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months

Exclusion Criteria:

* Sensory problems in the back and shoulders,
* Shoulder instability
* Osteoarthritis in the shoulder joint area
* Glenoid or bone fracture
* Frozen shoulder pathology
* Massive RM rupture
* Rheumatological joint problems
* Shoulder surgery history
Multidimensional Apathy in Psychiatric Pathologies.

Apathy is defined by quantitative decrease in goal-directed activity in comparison to the person's previous level of functioning. Apathy is a transnosographic symptom, prevalent in many neurological and psychiatric pathologies (specifically in schizophrenia and depression), and almost half of patients suffer from it. It is an important source of burden, affecting both personal and occupational life. Despite its high prevalence and negative consequences, no pharmacological or non-pharmacological treatments exist, the underlying mechanisms of apathy being poorly understood. The main aim of the present study is to advance in our knowledge of cognitive and neural mechanisms of apathy by using a multidimensional model of apathy, distinguishing three forms: executive, emotional and auto-activation/initiative.

the investigators hypothesize, independently of the pathology (schizophrenia and depression), the existence of different cognitive deficits underlying each of the 3 subforms of apathy. Indeed, according to the predictions of Levy and Dubois' model (2006), executive disorders underlie the cognitive form of apathy. It may be related to lesions of the dorsolateral prefrontal cortex and the cognitive territory of the basal ganglia. Emotional apathy could be due to motivational disorder. Dysfunctions or lesions in the orbital and medial prefrontal cortex and limbic territories of the basal ganglia may underlie this. Finally, the initiative form, may be a mixed form, with both motivational and executive difficulties. Lesions or dysfunctions may affect both the cognitive and limbic territories of the basal ganglia or the anterior cingulate cortex.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria (all subjects):
* age between 18 and 60 years
* men or women volunteers, hospitalized or not
* subject affiliated to an health insurance
* subject having signed an informed consent

Inclusion criteria (for schizophrenic patients):

- presence of DSM-V TR criteria for schizophrenia (American Psychiatric Association, 1994)

Inclusion criteria (for depressive patients):

- presence of DSM-V TR criteria for depression (American Psychiatric Association, 1994)

Exclusion Criteria:

* a major or non stabilized somatic disorder
* medical history likely to affect cerebral anatomy or linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)
* any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)
* sensory disabling impairments, and specifically visual acuity \< 8
* general anaesthesia during the 3 months before the study
* pregnancy (declared by the subject)
* persons in an emergency situation
* persons deprived in any way of their liberty
* persons in period of exclusion in an other protocol

Exclusion criteria (for controls):

- use of psychotropic substance during the 3 weeks before the study

Exclusion criteria (for patients):

- use of benzodiazepines
The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke At Acute Stage.

Objective: To comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage. We hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at acute stage. Method: Patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy). Patient will receive 20 consecutive sessions of intervention (5 time per week, totally 4 weeks) and assessments before and after the intervention within one week. In each intervention session, patients will receive 30 minutes unilateral or bilateral mirror therapy depending on their allocated groups and then 30 conventional occupational therapy. The patients recruited in the conventional occupational therapy group will receive 60 minute conventional therapy. The outcome measures at pre- and post-treatment will including the Fugl-Meyer Assessment for upper extremity (FMA-UE), the Modified Ashworth Scale (MAS), the Jamar Hydraulic Hand Dynamometer, the Chedoke Arm and Hand Activity Inventory (CAHAI), the Revised Nottingham Sensory Assessment (rNSA), and Functional Independence Measurement (FIM).


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke onset within 1 month
* The score of Mini-Mental State Examination (MMSE) is more than 24
* The score of Fugl-Meyer Assessment for upper extremity (FMA-UE) is between 18 to 56
* The score of Modified Ashworth Scale (MAS) is less than 3
* Willing to receive 3-5 sessions of the intervention per week, total 20 sessions consecutively
* Willing to sign informed consent

Exclusion Criteria:

* Unstable vital sign or complicating with other symptoms of neurological disease
* Auditory or visual function impairment
* Complicating with perceptual impairment (e.g., apraxia, neglect, or visual agnosia)
* Receiving botulinum toxin injection within 3 months
* Complicating with Wernicke's or Broca's aphasia