cyrilzakka/clinical-trials huggingface dataset:
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness

This study aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training.

It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the IPAQ short version, manometer and spirometry.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hypertension controlled by antihypertensive;
* aged between 60 and 80 years;
* absence of dementia or cognitive impairments that limit tests;
* absence of recent myocardial infarction;
* absence of musculoskeletal limitations that limit tests;
* availability of time on training days.

Exclusion Criteria:

* clinical instability;
* inability to perform any test.
Turkish Translation of Physical Activity Barriers and Facilitators Scale; Validity, Reliability, and Cultural Adaptation

Background:The aim of our study is to examine the validity and reliability of the Turkish version of the "Barriers \& Facilitators to Youth Physical Activity Questionnaire" in young individuals after cultural adaptation. The results of this study may shed light on youth PA participation studies, enable a clear explanation of the barriers and facilitators of physical activity in community-based research, and develop goal-oriented strategies for PA participation.

Material\&Method: The research will be carried out at İstinye University and young individuals between the ages of 18-24, who accepted to participate in the study as a result of the invitation and whose family consent was obtained, will participate in the research. The socio-demographic characteristics, age, gender, body weight, height and Body Mass Index (BMI) of the participants will be evaluated and recorded with a specially prepared evaluation form. All participants in the study will complete the Turkish version of the BFYPA,The Exercise Benefits/Barriers Scale (EBBS), Motivation for Participation in Physical Activity Scale (MPPAS), and the International Physical Activity Questionnaire (IPAQ) at their first visit. Translation and cultural adaptation process of the original BFYPA Beaton et al. (2000) with reference to the guideline .


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18and 24
* Being Turkish literacy

Exclusion Criteria:

* Having neurological and musculoskeletal problems that can change physical activity habits, -Having heart and respiratory system problems,
* Having diabetes mellitus,
* Using chronic medication,
* Having a body mass index of 35 kg/m2 and being above,
* Any other condition that prevents physical activities.
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility Criteria:
Inclusion Criteria:

All patients must meet the following criteria:

Patients must have incurable CRLM

Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm

Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team)

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Age \> 18 years

Subject life expectancy \> 3 months

Platelets \> 100×103/mm3

Total bilirubin \<1.5mg/dl

Creatinine level \< 2.0 mg/dl

All patients must sign an informed consent form

Exclusion Criteria:

The CRLM is amenable to curative surgical therapy

Uncorrectable coagulopathy

Subject is pregnant, nursing, or wishes to become pregnant during the study

Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival

Current or planned treatment with any experimental chemotherapy or target drugs
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.

Exclusion Criteria:

1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
2. Any of the following:

   1. Platelet \<50,000/mm3
   2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
   3. Total bilirubin \>2xULN
   4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/ min (adults)
3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
4. Concomitant use as well as use within 14 days before the start of the first study intervention of strong CYP3A4 inhibitors or inducers, strong Pgp inducers and sensitive CYP3A4 substrates.
5. Concomitant use of metronidazole from 2 days before the start of the first study intervention until 24 hours after last administration of study intervention.
6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
7. Known allergy/hypersensitivity to mebendazole and/or emodepside
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Men aged 18-45 years;
* Body mass index (BMI) in the range of 18.5 30.0 kg/m2;
* The confirmed "healthy" status;
* Left ventricular ejection fraction (LVEF) \> 50 % based on the results of EchoCG at screening;
* Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;

Exclusion Criteria:

* Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;
* Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;
* History or evidence of any chronic disease
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.


Eligibility Criteria:
* Eighteen years or older
* Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria:
* Diagnosis of autoimmune disorder
* Female 65 years of age or older
Impact of VVV Group for Veterans With SMI

Veterans with Serious Mental Illness (SMI) struggle with social integration - participation in work, housing, and citizenship - due to symptoms, stigma, and psychosocial challenges. Despite considerable VA efforts to provide mental health care to Veterans with SMI, programs that promote social integration are lacking. Veterans with SMI are at especially high risk for poor social integration and suicidal ideation during the COVID-19 pandemic. This project addresses this need with a group-based, peer specialist (PS) co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV targets Veterans with SMI who experience psychosis, a group particularly in need of support with social integration. Virtual VVV groups are co-led by VA mental health clinicians (MHCs) and PSs via online video conference. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of SMI: hallucinations, delusions, and social isolation. This intervention has the potential to create and foster a supportive community that improves the social integration of participants by reducing their distress and self-stigma, and increasing self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* DSM 5 diagnoses of schizophrenia, schizoaffective disorder, bipolar with psychosis, depression with psychosis, unspecified psychosis

Exclusion Criteria:

* Substance-induced psychosis,
* clinically significant neurological disease,
* history of serious head injury with loss of consciousness \> 1 hour.
Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

This study gathers information and samples for further analysis as part of the BEAUTY study. The purpose of the BEAUTY study was to better understand the reasons why or why not breast cancers respond to standard chemotherapy. Collecting samples of blood and tissue and health and treatment information from patients on the BEAUTY study may help doctors identify changes that make cancer better respond to standard chemotherapy and develop better therapies for the treatment of cancer.

PRIMARY OBJECTIVES:

I. Evaluate the association of residual cancer burden and breast cancer disease-free interval.

II. Evaluate the trajectory of circulating tumor cell (CTC) and circulating tumor-deoxyribonucleic acid (ctDNA) over time after breast cancer treatment and the association with breast cancer disease-free interval.

III. Evaluate the association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by cytometry by time-of-flight \[CyTOF\]) over time with breast cancer disease-free interval.

IV. Develop and use patient derived xenograft (PDX) models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.

V. Evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor.

VI. Assess the spatial immune micro-landscapes of pre-treatment and treated tumors.

VII. Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response and immune evasion mechanisms.

OUTLINE:

Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and/or undergo the collection of tissue samples throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* REGISTRATION - FOR PATIENTS STILL ALIVE:
* Enrolled in BEAUTY \[MC1137 (NCT02022202)\] and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
* Able to provide written informed consent
* REGISTRATION - FOR PATIENTS WHO HAVE DIED:
* Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
* Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years old.
2. Liver Cirrhosis
3. Portal hypertension
4. Stable disease in the absence of vasoactive agents
5. Signed informed consent form

Exclusion Criteria:

* 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG \<12mmHg 8. Plasma sodium \<130mmol/l 9. Serum creatinine \>2mg/dl 10. Serum bilirubin \>5mg/dl 11. INR\>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD\>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding
Testing the Engaged Approach to Lung Cancer Screening

The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.


Eligibility Criteria:
Inclusion Criteria:

The trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) LCS Program and (2) LCS Program Staff member.

Program inclusion criteria (n = up to 8 sites):

* Must conduct at least 50 low-dose computed tomography (LDCT) scans per year (baseline + follow-up)
* Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)

Staff member inclusion criteria (n \~ 5 at each site/\~40 participants total):

* Identified staff member of the LCS program site
* \>18 years of age
* Must be able to complete study surveys and interviews in English
* Willing to provide informed consent

Exclusion Criteria:

* none
Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Adults, equal to or more than 18 years years of age
* Patients with respiratory tract infections, including any of the following:

  * Acute tracheitis, acute tracheobronchitis
  * Acute sinusitis
  * Chronic sinusitis
  * Acute tonsillopharyngitis
  * Acute bronchitis
  * Mild community-acquired pneumonia
  * Acute exacerbation of chronic bronchitis

Exclusion Criteria:

* Known hypersensitivity to or previously intolerant of macrolides.
* Illness severe enough to warrant hospitalization or parenteral therapy.
* Concomitant use of any of the following medications:

  * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
  * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
  * Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
* Mental condition rendering the subject unable to understand the nature of the study.
Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives.

METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using piezosurgery was employed, 2) control group in which the cysts were removed using the conventional technique. The following parameters were assessed; postoperative pain, time of operation, hemorrhage control and field visibility, ease of operation, neurosensory evaluation and radiographic percentage of change in bone defect volume between preoperative and 3-months postoperative values.

Eligibility Criteria:
Inclusion Criteria:

* 1) Periapical cysts involving more than one tooth in close relation to the maxillary sinus, nasal cavity or inferior alveolar neurovascular bundle,
* 2) Intact labial/buccal cortical plate with no perforation.

Exclusion Criteria:

* 1) Patients with systemic diseases contraindicating surgery
* 2) Cases in suspicion of malignancy
Effect of Acupressure in The Management of Postmenopausal Constipation

This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.

Constipation is prevalent in menopause, affecting 4-29% of women globally, and can lead to serious complications like hemorrhoids, anal fissures, and colorectal cancer. While laxatives can help, long-term use may cause dependency and side effects. Alternative therapies are needed.

Deep breathing, particularly diaphragmatic breathing, may improve constipation by activating the parasympathetic system and promoting relaxation. Acupressure has also shown potential in managing constipation by stimulating intestinal activity, improving blood circulation, and regulating Qi flow.

Despite existing studies on acupressure and constipation, no research has specifically examined its effect on postmenopausal women. This study aims to investigate acupressure's impact on functional constipation in this population, offering potential insights for non-pharmacological management.

Eligibility Criteria:
Inclusion Criteria:

1. Sixty postmenopausal women who were clinically diagnosed as having functional constipation after menopause (at least one year after the stoppage of the last menstrual cycle)
2. Their ages ranged from 50 to 60 years old.
3. Their body mass index didn't exceed 30 kg/m2.
4. All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
5. They should stop laxatives intake during the treatment program.

Exclusion Criteria:

1. Irritable bowel syndrome or anal fissures.
2. Genital organ prolapse as rectocele.
3. Any neurological diseases, spinal diseases or spinal deformities.
4. History of bowel surgery.
5. Congenital anorectal malformation, stoma in situ.
6. Diabetes mellitus and sever distal venous insufficiency.
7. Skin eruption at the site of stimulation.
8. Implanted pacemaker or defibrillator.
9. Metalic implant in lower limb.
10. Recent surgery at the lower limb.
11. Peripheral neuropathy and neurological disorders.
12. Psychological distress.
A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819

This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
* Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.

Exclusion Criteria:

* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
* Any confirmed allergic reaction against any drug or multiple allergies
* Dietary restrictions that would prohibit the consumption of standardized meals
* Positive cotinine test and/or any use of nicotine containing products
* Clinically relevant history of constipation or bowel disorder
* Known intolerability to activated charcoal
Metabolic Availability of Tryptophan From White Maize

Our objective is to determine the metabolic availability of Tryptophan in white maize using the indicator amino acid oxidation (IAAO) technique in adult men.

Our objective is to determine the metabolic availability of Tryptophan in white maize. Seven young, healthy, male adults will receive graded levels (13.2, 26.4, 39.7, 52.9) of tryptophan requirement of 3.78 mg/kg/d as a crystalline amino acid (AA) mixture and a porridge of white cornmeal protein respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult males (20-49years old).
* Stable body weight
* Not on any medications that could affect protein and amino acid metabolism e.g. steroids.

Exclusion Criteria:

* Recent weight loss within the last 3 months or on weight reducing diet.
* Unwillingness to participate or unable to tolerate the diet.