cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation Needs of the Malaysian Haematological Cancer Survivors

Many cancers are being treated more effectively nowadays due to the raised awareness and early detection as well as advancement in researches and technology. Despite the rising number of cancer survivors in the coming years, these survivors are still plagued by the poor quality of life due to physical and psychological impairment. According to the National Cancer Registry Report from 2007-2011, haematological cancer is one of the ten most common cancers in Malaysian population. Many haematological cancer survivors in Malaysia are reportedly having poor quality of life due to multiple physical and emotional impairments which leads to further disability in life. It is thus an important effort to identify the rehabilitation needs in these cancer survivors to implement alternatives to improve the disease outcome through cancer rehabilitation.

A cross-sectional questionnaire-based study will be employed to identify the rehabilitation needs and predictors of needs in outpatient hemato-oncological cohort at UMMC Hemato-oncology Clinic for 12 months. The validated questionnaire employed evaluates the potential disabilities that could affect the aforementioned patients in domains such as communication, independence in mobility, self-care, social participation, handling relationships and domestic activity of daily living a month prior to the survey.

Participants of age between 18 to 80 years old, diagnosed with haemato-oncological illnesses will be screened; excluding potential participants who are too ill or cannot understand English, Malay, or Chinese; to be recruited in the research.

Based on the findings from the analysis, rehabilitation needs could be tailored accordingly to improve quality of life of these patients

Eligibility Criteria:
Inclusion Criteria:

* patient with haematological malignancy
* agreeable to participate in the interview

Exclusion Criteria:

* ill at the time of follow up
* unable to understand English, Malay or Chinese
* refuse to be interviewed
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus

This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions.

These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire \> 13 points) are included in case one of the following is present:

  * Tinnitus and neck complaints increase and decrease together
  * Tinnitus is low-pitched and increases during inadequate neck postures

Exclusion Criteria:

* Tinnitus related to Ménière's disease, clear otological or neurological causes
* Serious depression
* Contra-indications for cervical spine treatment
* Patient already received cervical physical therapy in the past 2 months
NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial

This is a multicenter screening protocol designed to identify patients with NSCLC who have tumor mutations in the KEAP1 or NRF2/NFE2L2 genes in order to determine potential eligibility for a biomarker selected clinical trial (CX-839-014, otherwise known as the KEAPSAKE trial). Circulating tumor DNA (ctDNA) present in blood samples collected from eligible patients will be analyzed by next generation sequencing (NGS) for selected biomarkers. A commercial liquid biopsy NGS test will be provided to study participants free of charge.


Eligibility Criteria:
Inclusion Criteria:

Patients with stage IV non-squamous non-small-cell lung cancer (NSCLC) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following:

1. Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
2. Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Age ≥ 18 years old on the day of signing informed consent.
5. Estimated life expectancy \> 3 months.
6. At least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
7. Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.

Exclusion Criteria:

Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs

CF patients enrolled in this protocol will be recruited from patients followed by the Adult CF Program at National Jewish Health. Patients will be selected based on planned use of a CFTR modulator by their primary physician. No patient will be started on (or will switch) CFTR modulator agents for the purpose of the study. After enrollment, biological samples may be collected at two different time points prior to treatment initiation. One set of samples will be collected at baseline health prior to CFTR modulator initiation or change. A second set of samples will be obtained in subjects at the time of acute pulmonary exacerbation, if one occurs prior to CFTR modulator initiation or change. Post CFTR modulator initiation study assessments will be obtained at least one month after starting treatment and continue up to 2 times a year (including during pulmonary exacerbations), in order to document longitudinal effects of therapies and changes in inflammatory biology over time. At the time of each biological sampling, blood, sputum sample, urine, and a quality of life assessment will be acquired in all enrolled subjects. In addition to demographic data, clinical data, such as quantitative microbiology and simple spirometry will be recorded at the time of sample collection.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CF with an eligible mutation for modulator treatment.
* Age 18 years old or older.
* Patient is starting a CFTR modulator as part of their clinical care or switching CFTR modulator therapy agents, pending FDA approval.
* Ability to perform reproducible Pulmonary Function Tests.
* Willingness to comply with study procedure and willingness to provide written consent.

Exclusion Criteria:

• Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD

The purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (VEGF) in exudative age-related macular degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition and metobolite levels will significantly vary according to VEGF levels. Based on the results of this pioneering clinical study, our research team will proceed to evaluate the individual anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites found.

The purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (VEGF) in exudative age-related macular degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition and metobolite levels will significantly vary according to VEGF levels.

Eligibility Criteria:
Inclusion Criteria:

* wet AMD eligible for intravitreal anti-VEGF treatment.
* Confirmed exudation on SD-OCT.

Exclusion Criteria:

* dry AMD.
* Disciform scar.
* Smokers.
* Morbid obesity.
* Patients undergoing other forms of treatment for wet AMD.
Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers

This study will be a randomized crossover trial that will be conducted at Rush University. The study will be conducted with 20 healthy volunteers who will be placed on ICU ventilator operating in the NIPPV mode. All subjects will perform 15 minutes of breathing on NIPPV on each mask of the 4 different masks (2 oronasal and 2 full face masks) that are randomly selected. Breathing through each mask will be followed by a 5- minute wash out period between masks. End tidal Carbon Dioxide (EtCO2) will be sampled nasal/oral. Different levels of EPAP will be set and CO2 clearance will be monitored. Additionally, subjective mask comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable.

This study will be a randomized crossover trial that will be conducted at Rush University. Normal volunteers will be recruited from Rush University Medical Centers. Volunteers will be screened with inclusion and exclusion criteria and an informed consent is required in order for them to participate.

Also, initial baseline vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be obtained. EtCO2 will be obtained at baseline and periodically using an oral/nasal sample line with the CapnostreamTM 20p monitor (Medtronic, Minneapolis, MN). The study will use a double limb circuit ICU ventilator Puritan Bennett™ (Medtronic, Dublin, Ireland).

Investigators will evaluate 4 NIPPV masks (2 oronasal masks and 2 full face masks). Oronasal masks will be labeled as group A and numbered as A1 and A2; while full face masks will be labeled group B and numbered as B1 and B2. Order of the masks will be randomly chosen in two steps. First steps will be choosing A or B then randomly assign mask in each of these groups. Investigators will randomly assign mask in group A or B by drawing an initial mask from the group and then continue the sequence of masks from that point. For example, investigators randomly chose group A, then randomly chose A2, the sequence will be A2, A1. Then Investigators would randomly choose B2, then the sequence would be B2, B1. All subjects will perform 15 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, \& 5 while IPAP remains at 5 higher than EPAP. EtCO2 will be collected at 4:00, 4:30 and 5:00 minute mark. These three measures should differ by less than 20% of their average. Also, subjective mask ORA: 18011502-IRB01 Date IRB Approved: 3/30/2018 Amendment Date: 5/11/2018 comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects greater than 18 years old.

Exclusion Criteria:

* Prior history of NIPPV as a patient.
* Facial surgery or deformity
* Ear infection
* History of pulmonary or cardiac disease
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.

Inclusion criteria

1. senile cataract
2. patients' age of 21 years or older
3. preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion criteria

1. pregnant, lactating women
2. presence of other ocular diseases which affect stability of lens capsule

Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness

Eligibility Criteria:
Inclusion Criteria:

* senile cataract
* patients' age of 21 years or older
* preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion Criteria:

* pregnant, lactating women
* presence of other ocular diseases which affect stability of lens capsule
Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria

This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.

Study aim is to examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.

A single group, pre/posttest design including structured questionnaires with adolescents living with HIV. Additionally, we will abstract clinical data from the medical record system. We will also conduct in-depth interviews with a subset of participants, as well as health care staff who are engaged in the intervention, at endline.

The objectives of this study are:

1. To examine the feasibility of implementing a mobile/electronic health (m/eHealth) intervention designed to improve retention in HIV care services and ART adherence among ALHIV ages 15-19 years through an online support group (using Facebook).
2. To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention.
3. To gather preliminary data on the psycho-social and health-related outcomes that the intervention is designed to affect to inform an outcome evaluation study that will be conducted following the conclusion of the feasibility study.
4. To collect information on recruitment, informed consent and data collection processes to inform the outcome evaluation study of the current intervention that will be conducted once findings from this feasibility study are incorporated into the intervention design.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive and currently on ART for at least 6 months
* Age 15 to 19 years
* Can demonstrate basic literacy necessary to participate in online chats

Exclusion Criteria:

* Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months)
* Currently enrolled in an in-person support group
* Currently enrolled in another research study related to HIV service retention or ART adherence
* Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy

We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).

We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.


Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 70 years old
* benign diseases of gallbladder
* selective cholecystectomy
* Capable to read and write

Exclusion Criteria:

* accept upper abdominal operation before
* acute cholecystitis
* with serious heart or pulmonary diseases
* with diseases of immune system
* Pregnant women
* can not understand the research purposes
* relatives of researchers
Opioid Prescription After Cesarean Trial

Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.

This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg. The primary endpoint was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women were assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization was stratified by site. Women were followed through 90 days postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
* Singleton, twin or triplet gestation

Exclusion Criteria:

* An opioid prescription filled during the current pregnancy
* Known history of opioid use disorder, by medical record review
* Contraindication to opioids (oxycodone)
* Contraindications to both acetaminophen and ibuprofen
* Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
* Fetal or neonatal death prior to randomization
* Inability to randomize within 1 day before planned discharge from the hospital
* Inability to participate in shared decision making as assessed by research staff
* Language barrier (non-English or Spanish speaking)
* Participation in this trial in a previous pregnancy
* Participation in another intervention study that influences the primary outcome in this trial
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Body surface area (BSA) affected with psoriasis between 4% and 20% .
* Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
* Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
* Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
* Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
* Male or female, 18 years of age or older at the time that the consent form was signed.
* Able to complete the study and comply with study instructions.
* Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

Exclusion Criteria:

* Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
* Other serious skin disorder or any chronic medical condition that is not well controlled.
* Female subjects who are pregnant, trying to become pregnant or lactating.
* Any major illness within 30 days prior to the baseline visit.
* Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

Clopidogrel causes significantly less peptic ulcer disease (PUD) and ulcer bleeding than low-dose aspirin in general population. However, clopidogrel is not safe enough for gastrointestinal (GI) mucosa in patients who had past history of aspirin-associated ulcer or ulcer bleeding. Aspirin plus proton pump inhibitor (PPI) is superior to clopidogrel alone in preventing recurrent ulcer bleeding in these high risk patients.

This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients with aspirin-associated PUD when they take PPI (rabeprazole 20 mg/day) to treat their PUD and simultaneously take aspirin or clopidogrel for their cardiovascular (CV) prevention. Two hundred patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day) or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks. The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.

If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence of ulcer healing and ulcer bleeding in the healing phase,PPI plus aspirin rather than PPI plus clopidogrel will be recommended during acute ulcer healing in patients who need antiplatelet therapy for their CV prevention.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have taken aspirin for more than 1 month and are found to have PUD by upper endoscopy will receive PPI (rabeprazole 20 mg once daily) to treat their PUD. PUD in the upper gastrointestinal (UGI) tract is defined as

  * \[1\] mucosal break of stomach or duodenum \> 3 mm in diameter; or
  * \[2\] more than 10 gastric or duodenal erosions, without malignancy proved by histopathological examination.

Exclusion Criteria:

* Patients will be excluded if they have PUD with bleeding (ulcer with adherent blood clot, visible vessel, oozing, or spurting) requiring endoscopic hemostasis,
* if they take other antithrombotic or anticoagulants simultaneously, if they have take NSAIDs, selective COX-2 inhibitors, or steroid,
* if they have take misoprostol or histamine receptor-2 antagonist (H2RA),
* if they have bleeding tendency (thrombocytopenia with platelet count \< 80000/mm3 or prolonged pro thrombin time \> 5 seconds),
* if they have anemia (hemoglobin \< 10 g/dL),
* if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past,
* if their age are \> 80 year-old or \< 18 year-old,
* if they have severe cardiovascular, pulmonary, hepatic, or renal disease.