cyrilzakka/clinical-trials huggingface dataset:
Community-based Communication for Blood Donation in Ghana

A randomized controlled trial to evaluate the effectiveness of the WhatsApp groups or docudrama compared to a control group (usual engagement with blood services) on repeat blood donation attempts among first-time blood donors in Ghana. Secondary outcomes will be blood donor retention, blood donation knowledge, attitudes, beliefs, motivations, intention to donate, and relatedness as potential mediators of blood donation behavior among first-time blood donors. The RCT will have three arms: 1. WhatsApp; 2. docudrama; 3. control. Each participant in the WhatsApp and docudrama arms will receive the intervention for 14 months. Participants in the control arm will receive standard national blood donation communications and be followed for 14 months. Actualized blood donation is possible every four months using NBSG guidelines; consequently, participants may make multiple blood donation attempts. Return blood donation attempts will be evaluated using the Southern Zonal Blood Center (SZBC) records (primary outcome) and participant self-report (secondary outcome) at 7 months and 14 months. Secondary measures will be evaluated at baseline, 7 and 14 months from enrollment. The duration of the RCT will be 26 months allowing for 12 months to achieve enrollment goals and 14 months of follow-up for the last individual enrolled.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years-old
* First-time whole blood donor with the SZBC of the NBSG
* Eligible to donate again at the time of eligibility confirmation
* Consent to participate
* Understands one of English, Twi, or Ga
* Have a smart phone
* Have, or be willing to sign up for an active WhatsApp account
* Be willing to watch a docudrama on blood donation in a group setting

Exclusion Criteria:

* History of more than one lifetime whole blood donation (with any blood center)
Blood Levels of Abacavir in HIV Infected Adolescents

The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.

ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.

There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* CD4 count greater than 100 cells/mm3
* Viral load less than 100,000 copies/ml
* Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry
* Weight more than 83 lbs (37.5 kg)
* Ability and willingness to swallow study medications
* Consent of parent or guardian, if applicable

Exclusion Criteria:

* Any Grade 3 or greater toxicity within 14 days prior to study entry
* Participation in PACTG P1018
* CDC Category C opportunistic infections or HIV-1 associated cancer requiring drug therapy at the time of study enrollment
* Treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry
* Received therapeutic vaccines or any HIV-1 vaccine given for primary prevention within 30 days of study entry
* Surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function
* History of chronic alcohol use
* Any clinically significant disease other than HIV-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study
* Chemotherapy for active cancer
* Pregnancy or breastfeeding
Wide Awake Surgery for Tendon Repair in Hand Trauma

Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia.

All patients aged 15 or above with hand trauma resulting in tendon injuries were included.65 patients undergoing tendon repair in wide awake anaesthesia were grouped as approach arm and another 65 patients of general anaesthesia group were kept as control arm.Range of motion of corresponding tendons were measured at completion of sixth postoperative week using goniometer.Total active range of motion were calculated according to criteria given by Strickland method and American Society for Surgery ofthe Hand (ASSH).

Functional outcomes were compared among two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender of age 15 years or above.
2. All of the patients with hand injuries with tendon repair required, operated within the hospital premises

Exclusion Criteria:

1. Patients allergic to agents of local anesthesia.
2. Patients with anxiety symptoms
3. Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.
4. Patients with associated nerve injuries.
5. Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.
6. Patients with massive contamination, crush injuries or infection which needs to be addressed and treated prior to definitive repair.
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 2 years of age (no upper age limit).
* Must be willing and able to receive post-test counseling, if applicable.
* Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
* Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

* Am in a life threatening condition at the time of enrollment
* Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
* Have participated or are participating in a clinical trial for an HIV vaccine.
* Have previously participated in this clinical trial.
Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i

The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement


Eligibility Criteria:
* Inclusion criteria

  1. Adult patients from 18 to 60 years of age.
  2. American Society of Anesthesiologists (ASA) physical status I and II
  3. Both genders
  4. Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
  5. El Ganzouri index Score ≥ 4
  6. Patients with BMI \< 35 kg/m2
* Exclusion criteria

  1. The patients who will be refusal or inability to give informed consent,
  2. ASA class III or IV
  3. El Ganzouri index Score \< 4,
  4. Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
  5. Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
  6. Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
  7. Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
  8. Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.
Infections in Pediatric Cancer Patients

A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy.

In each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software.

Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.

Imaging data Microbiological data Outcome The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy

Exclusion Criteria:

* No exclusions
Healthy Term Infants Fed Milk-Based Formulas

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.


Eligibility Criteria:
Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is singleton from a full term birth
* Infant's birth weight was \> 2490 g.
* Infant is between 53 and 115 days of age
* Infant is on infant formula and tolerating infant formula feedings
* Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.
The Effect of Mashed Potato Composition on Food Intake, Satiety and Blood Glucose

Potato is one of the world's most popular foods and is widely accepted as a staple food. The objective of this study is to determine the effect of consuming instant mashed potatoes with and without fat on glycemic response, subjective appetite and food intake. It is hypothesized that mashed potato with added fat (as it is usually consumed) will result in lower glycaemic response and subjective appetite, and reduced subsequent food intake.


Eligibility Criteria:
Inclusion Criteria:

* •Healthy men with a body mass index (kg/m2) of 20-24.9

Exclusion Criteria:

* •smocking, medication, breakfast skipping, restrained eating
Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.

The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. The reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. Numerous reports in the literature have validated the effectiveness of the reverse design.

Patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design. Both implants are FDA approved. The patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient that is a candidate for reverse shoulder arthroplasty this includes:

* rotator cuff tear arthroplasty,
* irreparable rotator cuff tear,
* significant proximal humerus fracture and malunions,
* chronic proximal humerus dislocation.

Exclusion Criteria:

1. Any patient with previous arthroplasty on affected shoulder.
2. Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.
3. Patients who do not want to participate or participate in follow-ups.
The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.

Right now, doctors use mild laxatives and stool softeners to help you have a bowel movement earlier and with less pain after surgery. Sometimes if the stool softener or mild laxatives do not work, you may need to use stronger laxatives or enemas. We want to see if specifically using SennaS is better for having a bowel movement soon after surgery and with less pain. SennaS is FDA approved for constipation. It has a stool softener and a mild laxative and has been shown to be safe and effective for treating constipation.

Eligibility Criteria:
Inclusion Criteria:

Women undergoing pelvic reconstructive surgery, including any combination of:

* Posterior/rectocele repair
* Paravaginal repair
* Anterior/cystocele repair
* Suburethral sling
* Abdominal sacrocolpopexy
* Midurethral sling (obturator pass)
* Burch urethropexy
* Midurethral sling (retropubic pass)
* Colpocleisis/colpectomy
* Uterosacral ligament suspension
* Sacrospinous ligament fixation
* Enterocele repair
* Anal sphincter repair
* Perineorrhaphy
* Use of graft material (synthetic or biologic) of any form/size does not affect inclusion, use of laparoscopy or robotic-assisted laparoscopy does not affect inclusion

Exclusion Criteria:

* Male
* Pregnancy (based on positive urine or serum ß-HCG measurement preoperatively in women who are not menopausal or have prior hysterectomy)
* Concurrent bowel resection,
* Hirschsprung's Disease or gastroparesis,
* Irritable \& inflammatory bowel disease (Crohn's Disease/ulcerative colitis) formally diagnosed,
* Clostridium difficile colitis during present hospitalization
* Inability to understand written study material,
* Inability to give consent
* Rectal bleeding or presently diagnosed colorectal cancer,
* Documented preoperative daily use of SennaS for more than 3 weeks,
* Known allergy to SennaS
* Inability to use suppositories/enemas
Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model

TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.

The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 60 years
* Signed informed consent
* Ulcerative colitis (UC) patients with active disease
* Crohn's disease (CD) patients with active disease

Exclusion Criteria:

* UC or CD patients in remission
* Patients between 18 and 60 years without informed consent
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9

This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels. Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965 items per STAR-PU and greater than 10% broad spectrum items. The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers"). The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions. The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.


Eligibility Criteria:
Inclusion Criteria:

* GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)
* GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).

Exclusion Criteria:

* none
Scoliosis Surgery Using the PASS® LP System

The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.

The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.

The following will be evaluated

1. The 3D correction of scoliosis:

   * Reduction of scoliosis in the coronal plane (Cobb angles)
   * Correction in the sagittal plane (kyphotic and lordotic angles)
   * Correction of the axial vertebral rotation in the transverse plane
2. The functional and aesthetic outcomes

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
* Male and female

Exclusion criteria:

* Neuromuscular or degenerative scoliosis
* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
* Primary muscle diseases, such as muscular dystrophy
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma)
* Primary abnormalities of bones (e.g. osteogenesis imperfecta)
* Congenital scoliosis
* Scoliosis requiring anterior release
* Previous spinal surgery
* Patient who is unable to complete a self-administered patient questionnaire
A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

This will be a Phase 3, 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline Visit (Day 1) as well as visits on Days 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit). In addition, there will be dispensing visits on Days 45, 135, 225, and 315.

At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Eligibility Criteria:
Key Inclusion Criteria:

* Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
* Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
* Schirmer test score with or without topical anesthesia as specified in the protocol within 1 year of the Baseline visit.
* Total ocular surface staining score as specified in the protocol at the Baseline visit.
* Corrected visual acuity as specified in the protocol at the Baseline visit.
* Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.

Key Exclusion Criteria:

* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety.
* Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
* Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
* Use of medications as specified in the protocol.
* Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.