cyrilzakka/clinical-trials huggingface dataset:
Myths and Misconceptions About HSCT in a Limited Resource Region

This study aimed to assess myths and misconceptions about hematopoietic stem cell transplantation, among students of medical colleges and to evaluate the value of an educational program in correcting those misconceptions. 218 undergraduate medical and nursing students included in this study. An intervention Quasi Experimental study design (pre/post-test) was used for this work.

This study aimed to assess myths and misconceptions about hematopoietic stem cell transplantation, among students of medical colleges and to evaluate the value of an educational program in correcting those misconceptions. The last aim was to detect further needs for advancement of health education about bone marrow transplantation at Assiut University.

Study subjects: two groups, Group 1: 5th year undergraduate medical students(118 students), Group 2: 4th year undergraduate nursing students(100 students). Each group were randomly selected . Both groups 1 and 2 assumed to have knowledge about BMT from their study courses, also they represent a sector from the general population that could be involved in a BMT team in their future career. this work that was conducted at Assiut University Faculties of Medicine and Nursing at Assiut Governorate during the period from July 2019 to May 2020. The subject's inclusion criteria were:

* Willingness to participate in the study
* Good ECOG performance status
* Intact physical and mental health

And the Exclusion criteria were:

* HSCT team
* Drug users

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study
* Good ECOG performance status
* Intact physical and mental health

Exclusion Criteria:

* HSCT team
* Drug users
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol

Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects aged 20 - 45 years
* A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria:

* Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
* Subject judged not eligible for study participation by investigator.
ADVM-022 Intravitreal Gene Therapy for DME

A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]

\*sponsor unmasked for enhanced safety monitoring as of May 2021

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of serious retinal vascular diseases including Diabetic Macular Edema (DME). DME affects up to 10% of people with diabetes is caused by fluid accumulation in the macula and is the most frequent cause of sight loss in people with diabetic retinopathy. Available therapies for treating DME include laser and anti-vascular endothelial growth factor (anti-VEGF) drugs. Anti-VEGFs require frequent and long-term intravitreal (IVT) injections to achieve and maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat DME by providing durable expression of an anti-VEGF protein (aflibercept) to limit abnormal blood vessel leakage. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment, progression of disease and subsequent vision loss in patients with DME.

In INFINITY, approximately 33 eligible subjects will be randomly assigned to receive one of the two doses of ADVM-022, or, assigned to the control arm to receive a sham ocular injection with a preceding aflibercept injection. Subjects who are assigned to receive ADVM-022 will be further randomized to receive a preceding aflibercept or sham ocular injection. All subjects will be assessed regularly and will receive additional aflibercept injections should DME disease activity progress.

The primary objective is to assess the durability of a single intravitreal (IVT) injection of ADVM-022. All subjects will be followed for 96 weeks after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Type 1 or Type 2 diabetes mellitus
* Willing and able to provide informed consent
* Vision impairment due to center involving diabetic macular edema

Exclusion Criteria:

* Uncontrolled diabetes defined as HbA1C \>10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months.
* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
* Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
* Known severe renal impairment
* High risk Proliferative Diabetic Retinopathy
* History of retinal disease in the study eye other than diabetic retinopathy
* History of retinal detachment (with or without repair) in the study eye
* History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
* Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
* Current or planned pregnancy or breastfeeding
Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.

Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts, subjective improvement in hearing , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old, who complain about blocked ear found to have ear wax which impacts ear drum and able to sign consent.

Exclusion Criteria:

* Patients who are contraindicated to ear syringing will be excluded : otitis externa , otitis media , history of tympanic membrane perforation , history or ear surgery , unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo after ear syringing .
Poultry Management and Child Diarrhea in Uganda

Fecal contamination from animal sources, specifically chickens, is increasingly recognized as a risk factor for enteric infections in low-income countries where domestic animals are often kept in close proximity to living quarters. Community members typically allow chickens to move freely around their compound and in their homes. Unlike other animals, such as cows or goats, poultry are typically not confined and their feces, which are relatively small, are considered relatively innocuous and therefore largely ignored by adults and children. In this study, the investigators have implemented an intervention to help rural poultry owners with children to hygienically separate chickens from children by focusing on a small set of key factors, including increased risk perception, increased perception of potential livelihood benefits, increased skills, and increased supportive social norms. The investigators hypothesized that the poultry hygiene intervention will lead to improved poultry management practices, which will in turn lead to reduced fecal contamination in the domestic environment and subsequently reduced diarrheal illness in young children. To measure these parameters along the causal chain, the investigators used a combination of household surveys, spot check observations and testing of environmental samples for fecal contamination.


Eligibility Criteria:
Inclusion Criteria:

* At least one person in the household is a member of Self-Help Groups formed by The Water Trust, Uganda
* There is at least one child under the age of 5 years living in the household
* There is an adult (\>18 years) primary caregiver of a child \<5 years available for participation in study

Exclusion Criteria:

* None
Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers

* To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo.
* The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.
* Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment
* Exploration of the pharmacokinetics of BI 1026706
* Exploration of safety and tolerability of BI 1026706


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
2. Age 18 to 55 years (incl.)
3. BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).


Eligibility Criteria:
Inclusion Criteria:

* T1D for at least 6 months at the screening visit.
* Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:

  * insulin lispro U-100, or
  * insulin aspart
  * insulin glulisine or
  * fast acting insulin aspart
* Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:

  * insulin glargine U-100 (once a day \[QD\] or twice a day \[BID\]), or
  * insulin detemir U-100 (QD or BID), or
  * insulin degludec U-100 (QD)
* Have a HbA1c value ≤ 9.9% at the screening visit.

Exclusion Criteria:

* Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
* Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.
Standing Tall (Yima Nkqo)

The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."

The premise for our study is based on three decades of HIV research that supports the need for multi-component, multisystem interventions to promote testing, and adherence to treatment and care for young people living with HIV. The proposed intervention, Standing Tall, is informed and guided by Social Action Theory - a conceptual framework reflecting a holistic understanding of health behavior and motivational factors that foster and maintain behavior change. Standing Tall, a pilot randomized controlled trial, is designed to address multi-factorial barriers using (1) a socio-behavioral group intervention; (2) social support; (3) provision of immediate ART and refills. The primary outcome is ART initiation at three months, and the secondary outcome is viral load suppression at six months. Other tertiary/exploratory outcomes include behavioral outcomes and process evaluation of the intervention itself, and the use of point-of-care diagnostics.

The administrative supplemental funding provides support for an additional objective of this study: to understand how best to use point-of-care (POC) testing in clinical practice in order to improve HIV care and treatment for South African young people. Understanding patient perspectives and perceived barriers is critical to developing feasible, acceptable, and effective protocols for implementing POC testing. The primary aim for achieving this objective is to assess patient perspectives regarding POC testing through in-depth, semi-structured interviews among study participants enrolled in Standing Tall's second aim.

Eligibility Criteria:
Inclusion Criteria:

* Complete an assessment of understanding
* Provide informed consent
* Are between ages 18-24
* Present to Tutu Tester vans in Cape Town OR East London DTHF clinics (Duncan Village Day Hospital, Empilweni Gompo Health Centre, Gompo C Clinic) and test HIV+
* Are ART-naïve
* Are English or isiXhosa speakers
* Reside in the Cape Town or East London metro area

Exclusion Criteria:

* Are pregnant (must be referred to antenatal clinic if living with HIV)
* Test positive for tuberculosis (must be referred to clinic for TB treatment prior to ART initiation)
* Are unable to understand the process of informed consent
Cardiovascular Mortality Associated With Abnormal Calcium Metabolism

The purpose of this cohort study is to estimate the risk of cardiovascular mortality associated with abnormal calcium metabolism


Eligibility Criteria:
All ESRD patients who indicated dialysis in 1990-1993
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery

This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification

This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* ≥21 years of age and in good general health at Visit 1 (Screening)
* Willing and able to provide informed consent and provide relevant privacy authorization(s)
* Willing and able to comply with study requirements and visit schedule
* Clear ocular media (other than cataract) in the study eye
* Planning to undergo routine unilateral cataract surgery via phacoemulsification extraction and implantation of an intraocular lens.

Exclusion Criteria:

* Any ocular pain at Visit 1 (Screening)
* Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
* Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
* Willing and able to adhere to contraception requirements.

Exclusion Criteria:

* Participant was mentally or legally incapacitated
* History or presence of clinically significant medical or psychiatric condition or disease.
* History of any illness that might have interfered with drug absorption.
* History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
* History or presence of alcoholism or drug abuse.
* Female participants who were pregnant or lactating.
* Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
* Serum ceruloplasmin and copper values outside of the normal range at screening.
* On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
* Participation in a previous clinical trial with ALXN1840.
Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study

In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.

Hypothesis:

1. When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
2. When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.

Patients sent to our outpatient clinic for eventual primary THR are informed about this study and written patient information given to them. When patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included.

Block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms.

Patients will be blinded for the type of stem and method of planning. Investigators are blined in terms of methods of planning. In terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it.

The preoperative investigation includes routine investigation and an additional CT scan plus evaluation of the "University of California at Los Angeles" (UCLA) activity level and "Short Form Health 36" (SF-36) score. The same applies for the postoperative investigation and 3 months. The follow-up visits at 1, 5 and 10 years are routine investigations with additional UCLA and SF-36 Scores.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 40-70 years scheduled for primary THR
* signed written informed consent.

Exclusion Criteria:

* Charnley class B and C
* ASA score \>2
* pregnancy
* gross hip deformity making complex hip reconstruction (greater trochanter advancement, acetabular augmentation, femoral osteotomy, use of cemented or revision stem) necessary
* immature patients and patients incompetent to judge