cyrilzakka/clinical-trials huggingface dataset:
Translation of Modified Fatigue Impact Scale in Urdu Language

Cross cultural analytical study to translate Modified fatigue impact scale MFIS) in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of traumatic brain injury. No such study has been previously conducted in Pakistan which translate this scale in Urdu and follows the proper cross- culture adaptation.Condition or disease: Traumatic brain injury. Convenient sampling technique would be used.

The MFIS is a modified version of 40-item Fatigue Impact Scale (FIS). The MFIS impact scale consist of 3 subdivisions containing 9 physical items , 10 cognitive items and 2 psychosocial. The maximum score is 84 which is obtained by the sum of all the questions The higher score means high impact on quality of life. This version should be answered by the patients with traumatic brain injury. It is the patient's self- report. As the MFIS is well- developed measurement scale, it is meaningful to translate and validate this scale in Urdu Version. It is useful the study the effect of fatigue in the patients with TBI by using same measurement items so that a more direct comparison can be made. Therefore, the aim of the study is to translate and validate the Modified Fatigue Impact scale in Urdu language The translation and cultural adaptation process would start after obtaining approval from the developer of the original MFIS. This would be done according to WHO guidelines. Translation will be done by symmetrical category. The purpose will be to gain uniformity in the translation of tool in both the Target language and source language. This will involve 5 steps. (Forward translation, synthesis 2, Backward translation, synthesis 2 and pilot testing). Phase 2 would be done according to the guidelines of COSMIN in which psychometric properties will be measured.(reliability, internal consistency, construct validity and factor analysis.)

Eligibility Criteria:
Inclusion Criteria

* Age 18-65 years
* Both Male and Female
* Patient Able to read Urdu Language
* Any period of loss of consciousness after 1 hour of injury
* Patients who can actively participate in community
* For comprehension patients with the MMSE score \> 25 will be included

Exclusion Criteria:

* Patients able to perform 5 meter walk test
* Patients having score \>6 in FIM scale
* For alcohol abuse patients with the score \< 8 in AUDIT scale
* Any other neurological disease including Alzheimer, Parkinson's disease and Schizophrenia
Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease

Patients with inflammatory bowel disease (IBD) frequently undergo endoscopic examination and may suffer from diagnostic procedures. Independent from IBD patients, colonoscopy is usually performed using air insufflation, however recent data indicates a superior role of carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of patient's discomfort. The role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined, wherefore this study aims to address this issue.

Patients with inflammatory bowel disease (IBD) suffer from a chronic inflammatory course of disease. To stage the course of disease endoscopic procedures including colonoscopy may be required and especially IBD patients with their inflamed gut may suffer from repetitive endoscopic examinations including colonoscopy. Independent from IBD patients, colonoscopy is usually performed using air insufflation, however recent data indicates a superior role of carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of patient's discomfort which has been mainly demonstrated in groups of patients undergoing cancer surveillance colonoscopies and who do not suffer from IBD. Therefore the role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined and this study aims to address this issue. For pain assessment a visual analogue scale will be used. As the primary outcome measure, the investigators will compare the differences in pain level 1h after colonoscopy (comparison of carbon dioxide to air insufflation). For the secondary outcome measure the investigators will compare the differences in pain level 3h, 6h and 24h after colonoscopy (comparison of carbon dioxide to air insufflation).

Eligibility Criteria:
Inclusion Criteria:

* Patient with inflammatory bowel disease
* Indication for colonoscopy
* Age 18-80 years
* signed consent form

Exclusion Criteria:

* Consent form not signed
* Age \< 18 or above 80 yrs
* Pregnancy or Breast-Feeding
Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.

Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.

Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.

Survival Follow-Up: All patients will be monitored for survival.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
2. Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
3. Received rituximab containing a multi-agent therapy for the treatment of NHL.
4. Not eligible for high-dose chemotherapy and stem cell transplant.
5. Patients with DLBCL transformed from indolent lymphoma must have had a complete or partial response to a therapy for NHL lasting at least 12 weeks.

Exclusion Criteria:

1. Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma, defined as documented progression within 12 weeks of the last cycle of the first-line multi-agent regimen.
2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
3. Any experimental therapy ≤ 28 days prior to randomization
4. Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
5. Any contraindication or known allergy or hypersensitivity to any study drugs
6. Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
COMPLliancE and qualiTy of lifE in Asthma

A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece

Dry powder devices, available since 1970, have been developed to make inhalation simpler than pMDIs and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. In addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6.

The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

* Improves the symptoms,
* Reduces nightly asthma symptoms,
* Improves pulmonary function,
* Reduces the use of β2-agonists for rapid action,
* Reduces the number of seizures,
* Does not increase the risk of hospitalizations due to asthma,
* Achieves clinical asthma control in more patients, faster and with less ICS than would be required if ICS were administered alone.

The greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed.

Stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ICS doses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female asthma patients over 18 years of age
* Compliance with treatment
* Compliance with study procedures
* Signed informed consent form
* Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:

  1. Patients receiving ICS inhaled and SABA invoked
  2. Patients receiving inhaled ICS and LABA with separate devices each
  3. Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
  4. Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA

Exclusion Criteria:

* Male or female asthma patients under 18 years of age
* Unsigned patient consent
* Non-compliance with treatment
* Non-compliance in study procedures
* COPD patients (at any stage)
IN-TANDEM Familial Hypercholesterolemia Pilot Study

The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national initiative that utilizes machine learning and data mining techniques to identify individuals whose profiles are consistent with FH patients. The algorithm will be tested in adults with at least one cardiovascular comorbidity. Study subjects will be asked to provide either a saliva, buccal or venous blood sample for DNA and biomarker analysis


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* At least one cardiovascular co-morbidity or receiving treatment for a cardiovascular comorbidity
* Algorithm score 0-1
* Most recent encounter with a provider within five years of query date

Exclusion Criteria:

* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound study data
Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.

This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study in women undergoing ICSI treatment.

The primary objective of the study was the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age who were undergoing intracytoplasmic sperm injection treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patient for whom ICSI treatment is justified
* Serum follicle-stimulating hormone concentration
* Anti-mullerian hormone concentration
* Antral follicle count
* Body mass index and body weight
* Presence of both ovaries
* Regular spontaneous cycles between 21 and 35 days in length
* Normal uterine cavity as assessed by transvaginal sonography at Screening
* Willing and able to comply with the protocol
* Willing and able to provide written informed consent

Exclusion Criteria:

* Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study
* Previous poor responders
* Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome
* Patients with a history of or current polycystic ovarian morphology syndrome
* Patients with a history of or current endometriosis III or IV
* Presence of ovarian cyst at Screening
* Any contraindication to becoming pregnant
* History of ≥ 3 clinical or preclinical miscarriages
* Abnormal cervical smear, Papanicolaou \[PAP\] score ≥ 3
* Any history of malignant cancer other than in situ breast or skin cancer requiring local excision
* Any endocrine abnormalities requiring treatment
* Any clinically significant systematic disease
* Any known infection with human immunodeficiency virus, hepatitis B or C
* History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting
* Family history of genetic risk factors concerning pregnancy or birth
* Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures
* Active smoking
* Any active substance abuse of drugs, medications or alcohol within the last five years
* Patients in an institution by official or court order
* Patients who are unable or unwilling to provide informed consent
* Any participation in another clinical trial within the last 60 days before randomisation
* Previous FSH-GEX™ administration.
* Known hypersensitivity to any component of the investigational and non investigational products used in this study
A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.

Management of lung cancer remains very controversial for elderly patients (pts) and they are often excluded from clinical trials. We present here a survey performed about the management of lung cancer pts aged 70 or more in France. All pts aged 70 or more with histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating centers were recorded and their characteristics, the diagnostic procedures, therapeutic management and survival were analysed.


Eligibility Criteria:
Inclusion Criteria:

* histo/cytologically proved lung cancer

Exclusion Criteria:

-
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC

To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form voluntarily.
* Histologically or cytologically documented hepatocellular carcinoma.
* CNLC IIa IIb or IIIa
* The main portal vein was not completely obstructed,
* Child-Pugh A or B
* At least one measurable lesion according to RECIST criteria
* ECOG PS 0-1
* Adequate organ function
* Estimated life expectancy of ≥3 months
* For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent

Exclusion Criteria:

* Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
* For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
* The main portal vein and the left and right primary branches were clogged with cancer thrombus
* History of hepatic encephalopathy or liver transplantation
* Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
* Occurred arteriovenous thromboembolic events within 6 months before the first administration.
* Inadequately controlled hypertension.
* Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
* Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
* Severe infections.
* Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
* Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
* Unable to receive an enhanced CT or MRI scan of the liver.
Impacts of Opioids on Respiratory Drive During Sleep

The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Healthy controls: Apnea Hypopnea Index (AHI) \< 5 events/hr on in-laboratory PSG within 3 months of enrollment
* OSA group: AHI \> 10 events/hr on in-laboratory PSG within 3 months of enrollment; treated or untreated.

Exclusion Criteria:

* Sleep disordered breathing or respiratory disorders (other than OSA in the OSA group), such as central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
* Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
* Any unstable major medical condition.
* Medications expected to stimulate or depress respiration (including other opioids taken at home, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* History of allergy to lidocaine or oxymetazoline.
* Contraindications for morphine, including:
* allergy to morphine or opioids
* chronic obstructive pulmonary disease, asthma, or other significant respiratory disorders
* kidney or liver dysfunction, as this can affect the metabolism and excretion of morphine, leading to increased risk of toxicity.
* women who are pregnant or breastfeeding will be excluded due to potential risks to the fetus or infant.
* history of substance abuse, particularly opioid abuse, will be excluded to prevent potential misuse or relapse.
* current use of central nervous system depressants.
* individuals with gastrointestinal obstruction. Constipation is not an exclusion criterion because morphine is only administered for one night.
* recent head injury, brain tumors, or other conditions leading to increased intracranial pressure.
* unstable heart disease, particularly those with risk factors for or a history of heart rhythm disorders.
* epilepsy or a history of seizures, as morphine can lower the seizure threshold.
* severe psychiatric conditions, particularly those with a history of psychosis, as opioids can exacerbate these conditions.
* medications that interact with morphine, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and the atypical antidepressants buproprion and trazodone.
* untreated or unstable endocrine disorders like adrenal insufficiency or thyroid dysfunction.
The Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic Cardiomyopathy

In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.

A total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.

Eligibility Criteria:
Inclusion Criteria:

* history of cardiomyopathy
* etiology not known
* family history of cardiomyopathy
* ability to understand and sign the informed consent

Exclusion Criteria:

* refusal to participate
* pregnancy
* current participation in another active treatment study
Correlation Between Neck Pain and Visual Disturbances in Smartphone Users

the goal of this study is to Investigate the correlation between neck pain and visual disturbances in smartphone users.

Study design:

Cross-sectional observational analytical study design conducted on smartphone users 2- Subject selection 141 subjects (who are smartphone users) according to sample size calculation will be selected randomly to complete the neck disability index and visual functional questionnaire 25 version 2000

Eligibility Criteria:
Inclusion Criteria:

* 141 subjects who are smartphone users
* Age between 18 to 50 years
* Both genders are included
* Subjects Who put in more than 4 hours a day using smartphone
* Participants without systemic illnesses or physical deformities were also included
* Consent: Participants who provide informed consent to participate in the study.
* Neck disability index will be used to assess how your neck pain has affected your ability to manage in everyday life.
* Visual Functioning Questionnaire version 2000 will be used to assess vision-related quality of life

Exclusion Criteria:

* People with head and neck injuries
* eye diseases
* People with diabetic retinopathy
* who had refractive correction surgery
* psychiatric problems (depression)
* people with systemic illnesses or physical deformities
* people who have vision impairments and disabilities
Glucose Frequent of A1GDM in Labor

This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.


Eligibility Criteria:
Inclusion Criteria:

* All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM
* Patient with singleton gestation presenting in labor or for induction
* Patients who had "good" glucose control and were A1GDM. Good Control;

  * - Patient with overall outpatient glucose average of less than 100
  * - No evidence of fetopathy, large for gestational age or polyhydramnios.
  * - Hgb A1c \<5.7

Exclusion Criteria:

• If patient's admission accu check is \>120