cyrilzakka/clinical-trials huggingface dataset:
Assessing a Risk Model for G6PD Deficiency

A clinical study designed to develop and inform an individual risk of hemolysis model based on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with primaquine as per national guidelines and with confirmed normal G6PD levels as per the fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14 days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be followed intensively during treatment and for 14 days after treatment for haematologic measures, G6PD quantification, and drug level assays.

Open label, randomized trial with 72 total participants assigned to one of two treatment arms. Each arm will have 36 participants comprised of 12 males hemizygous for wildtype G6PD, 12 females homozygous for wildtype G6PD, and 12 females heterozygous for G6PD with a normal fluorescent spot test (FST) (G6PD genotype abnormal with G6PD activity ≥40% and ≤80% of normal). Arm 1a will receive primaquine for 14 days, and Arm 1b will receive chloroquine for 3 days and concomitant primaquine for 14 days. All participants will be healthy volunteers without severe G6PD deficiency who will be followed for two weeks after completing their study drug dosing. Pregnant women and those breastfeeding will be excluded. Venous blood samples will be taken at regular intervals for haematologic measures, G6PD quantification, and drug level assays. G6PD levels will be measured both by spectrophotometry to provide whole blood G6PD levels normalized for hemoglobin, as well by flow cytometry to to provide red blood cell G6PD distributions throughout the treatment and post treatment. Changes in the G6PD distributions will be modeled, incorporating other critical haematological indicators collected throughout the study too.

Eligibility Criteria:
Inclusion Criteria:

* Previous G6PD test at Shoklo Malaria Research Unit (SMRU) clinic with one of following results: 1) G6PD homozygous wildtype females (G6PD genotype normal) 2) G6PD heterozygous females with a normal FST (G6PD genotype abnormal with G6PD activity ≥40% and ≤80% of normal ) 3) G6PD hemizygous wildtype males (G6PD genotype normal)
* Willing to participate and sign informed consent form
* Willing to allow donated samples to be used in future research
* Aged ≥18 years
* Ability (in the investigators' opinion) and willing to comply with all study requirements

Exclusion Criteria:

All participants:

* Malaria or other illness
* Recent history (within 20 days) of anti-malarial treatment
* History of allergy or adverse reaction to chloroquine or primaquine
* Blood transfusion in the past 3 months
* G6PD activity less than 40% normal activity or 3.00 IU/gHb by the quantitative G6PD spectrophotometric assay
* Haemoglobin ≤10 g/dL
* Presence of any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study

Female participants only:

* Pregnancy at the time of screening
* Breastfeeding
Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand how caffeine may augment the effects of intermittent hypoxia on motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

The investigators will examine the effects of acute intermittent hypoxia (AIH) as a possible therapeutic intervention to promote functionally useful motor recovery. In this sub-study, the investigators will assess changes in leg motor function in response to repetitive AIH with and without caffeine.

Participants will receive caffeine+AIH, placebo+AIH, caffeine+SHAM in a randomized order. Before each intervention round, subjects will be asked to avoid caffeine-containing substances for 48 hrs (\> 5\* half-life of \~7 hrs) prior to arrival to control for baseline plasma levels of caffeine. Subjects will then ingest capsules containing either placebo (dextrose) or caffeine (up to 6mg/kg). Capsules will be prepared by Johnson Compounding \& Wellness. Blood samples will be collected before and after the breathing intervention to assess caffeine concentrations within the body.

During and after each intervention, both the rate and extent of magnitude changes in voluntary and involuntary muscle response behaviors important for walking will be compared between interventions within participants. Repeated measurements will be collected on all subjects that participate in the multiple interventions.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and 75 years (the latter to reduce likelihood of heart disease)
* medical clearance to participate
* lesion at or below C2 and above L5 with non-progressive etiology
* classified as motor-incomplete with visible volitional leg movement
* injury greater than 6 months
* ability to advance one step overground without human assistance

Exclusion Criteria:

* Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
* Pregnant women because of the unknown affects of AIH on pregnant women and fetus
* History of seizures, brain injury, and/or epilepsy
* Undergoing concurrent physical therapy
* Diabetes
* Cirrhosis
* Caffeine and/or NSAID allergies or intolerances
Effects of Conductive Exercises on Motor Skills Among the Children With CP

Cerebral palsy (CP) is defined as a neurodevelopmental disorder in which there are abnormalities of motor skills, muscle tone ,and, movement and is caused by injury to the developing brain. Risk factors for cerebral palsy are most probably intrauterine exposure to infection or inflammation and disorders of coagulation.Cerebral palsy (CP) is classified as Spastic, Athetoid, Tremor, Rigidity, Ataxic, Atonic, and Mixed.

Cerebral Palsy (CP) is the most common cause of physical disability in early childhood and overall, the CP rate is between 2 and 3 per 1000 live births.There are several interventions to manage cerebral palsy depending upon the severity and type of cerebral palsy and hence requires a multidisciplinary setting for proper improvement and management.One of the important intervention is conductive education including conductive exercises (CE).

Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program.

Group A: Experimental group:

Group A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength.

Group B: Control group:

Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.

Both the groups will receive intervention for 45 minutes per session 5 days in a week for 2 month. Data will be collected at baseline and after the completion of the study. Data will be collected after ethical approval and consent. All the personal information of the patient will be kept confidential.

Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy
* GMFCS level I, II and III
* Age group 6 to 12 years
* Either gender

Exclusion Criteria:

* Had a botulinum injection for reduce spasticity
* Subjects with any cardiac problem(congenitally)
* Children who are having visual and hearing deficits
Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).

For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received DBS implantation for the treatment of OCD

Exclusion Criteria:

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Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas

This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.

Quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. Quarfloxin was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed solid tumors or lymphomas.
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
* One or more tumors measurable on radiograph or CT scan, or evaluable disease (e.g., malignant ascites).
* Karnofsky performance status of greater than or equal to 70.
* Life expectancy of at least 3 months.
* Age at least 18 years.
* Patients must have central IV access, or agree to the insertion of a central IV line.
* Normal oxygen saturation by pulse oximetry on room air
* A negative pregnancy test (if female).
* Acceptable liver function as evaluated by laboratory results
* Acceptable renal function as evaluated by laboratory results
* Acceptable hematologic status as evaluated by laboratory results
* No clinically significant urinalysis abnormalities
* Acceptable coagulation status as evaluated by laboratory results
* Fertile men and women must use effective contraceptive methods during the study.

Exclusion Criteria:

* Seizure disorders requiring anticonvulsant therapy.
* Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months).
* Severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable pulmonary compromise.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Pregnant or nursing women.
* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Unwillingness or inability to comply with procedures required in this protocol.
* Known infection with HIV, hepatitis B, or hepatitis C.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who are currently receiving any other investigational agent.
* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.
Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.

Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.

Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.

Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).

Eligibility Criteria:
Key Inclusion Criteria:

* Provide written informed consent;
* Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening;
* Total area of CNV \> 50% of the total lesion area in the study eye at Screening;
* Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
* Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Key Exclusion Criteria:

* Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
* Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening;
* Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening;
* Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
* Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
* Pregnant or nursing women; women of child-bearing potential;
* Stroke or myocardial infarction in the 6-month period prior to Baseline.
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients

The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.

simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation \& decreasing steroidogenesis (production of progesterone \& testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia\& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters\& IVF-ICSI outcome in Pcos patients.

Eligibility Criteria:
Inclusion Criteria:

* Pcos patients
* Age \<40 years
* FSH\<10 IU/L

Exclusion Criteria:

* Endometriosis grade 3 \&4
* History of tubal surgery
* Hydrosalpinx
* History of mellitis diabetes
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy.
* Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
* Planning to take the same AI therapy for at least 15 weeks.
* New or worsening joint pain and/or myalgias since starting the AI therapy.
* Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
* The complete list of inclusion criteria is provided in the protocol.

Exclusion Criteria:

* Metastatic breast cancer.
* Planned surgery during the 15-week study period.
* Clinically significant laboratory abnormalities.
* Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
* History of or currently has suicidal ideation or attempted suicide.
* History of seizure other than febrile seizures in childhood.
* The complete list of exclusion criteria is provided in the protocol.
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Specific Aim 1: To compare the surgical site infection (SSI) rates of the current severe open fracture antibiotic strategy to a revised SEXTANT treatment strategy designed to address the modern wound bioburden at the time of wound closure or coverage.

Specific Aim 2: To compare the terminal bioburden of the wounds at the time of definitive closure or coverage as sampled by standard tissue microbiology.

Specific Aim 3: To compare rates of antibiotic-related serious adverse events (SAEs) of the two treatment groups.

Exploratory Aim 4: To pilot the use of available and emerging rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Injury meeting at least one of the following criteria:

   * Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon) requiring a second procedure for final debridement and definitive coverage / closure following the index stabilization
   * Gustilo type IIIB ankle fractures (OTA 44)
   * Gustilo type IIIB calcaneus fractures (OTA 82)
   * Gustilo type IIIB talus fractures (OTA 81)
   * Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
2. Ages 18 - 64 years inclusive
3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
4. Patients may have a traumatic brain injury.
5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
6. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.
7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
10. Patients may have a fasciotomy.

Exclusion Criteria:

1. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
2. Patient likely to have difficulty maintaining follow-up, including:

   * Diagnosis of a severe psychiatric condition
   * Intellectually challenged without adequate family support
   * Resides outside of the hospital's catchment area
   * Planning to follow-up at another medical center
   * Being a prisoner
   * Not having a means of contact (address, cell phone, home phone, e-mail)
Italian National Study on the Critically Ill Liver Transplant Patient With an Infection

Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern

The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs

Eligibility Criteria:
Inclusion criteria

1. Age\> 18 aa
2. Sex: Both
3. written consent to participate in the study
4. having been undergone to OLT in the 10 years prior to enrollment
5. Infection diagnosis (any type, any localization, any agent)
6. Being admitted in the ICU

Exclusion criteria 1. Death within 72 hours of admission 2. Withdrawal of consent

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