cyrilzakka/clinical-trials huggingface dataset:
Cervical Cancer Screening in Cameroon

Human immunodeficiency virus-infected (HIV\[+\]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV\[+\] and HIV\[-\] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV\[+\] women. This cervical cancer screening study of 1,200 women (800 HIV\[+\] and 400 HIV\[-\] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV\[+\] and HIV\[-\] women.


Eligibility Criteria:
Inclusion Criteria:

* Women living in Limbe town and neighborhood
* Confirmed to be HIV\[+\] or HIV\[-\]
* Have never undergone cervical cancer screening, with no history of ICC
* Willing and able to competently understand and provide written, informed paper-based consent
* Women who are having a menstrual period will be deferred for 2 weeks from participating in the study

Exclusion Criteria:

* Pregnant women
* Women with signs of abnormalities
* Non-menstrual bleeding suggestive of ICC
* Without a cervix because they have undergone hysterectomy
* Based on the judgment of the clinicians not sufficiently healthy to participate in a research study
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)

This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.
* Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature \> 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism

Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.

Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years (male or female)
* Patients were admitted to hospital within 72h of stroke onset
* Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
* NIHSS score ranged from 3-21 points
* Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of\>6.1%
* Patients could cooperate with the test and evaluation of relevant indicators in the trial.

Exclusion criteria:

* Pregnant or lactating women
* Patients with severe heart, liver and kidney dysfunction
* Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
* Patients with physical disabilities, joint deformities or muscle lesions
* Patients were confirmed with intracranial hemorrhage by CT
* Patients were allergic to the study drug
* Patients suffering from severe systemic infection
* Patients who had participated in other clinical trials within 1 month
* For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
* Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
* Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
* Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
* Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
* Written informed consent obtained prior to study

Exclusion Criteria:

* Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
* Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
* Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
* Ascites
* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
* Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
* Renal insufficiency (serum creatinine and potassium must be within normal limits)
* Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
* Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
* Hypersensitivity to active ingredients
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms)

Exclusion Criteria:

* Over 65
* Renal or liver disease
* Diabetes
* Hypertension
* Taking thiazides or ACE inhibitors
SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients

Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

Passive immunization using intravenous immunoglobulins (IVIG) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. Recently researchers from China reported satisfactory recovery of critically ill Corona Virus Disease 2019 (COVID 19) patients when high dose intravenous immunoglobulin (IVIG) were administered.

Research team at Dow University of Health Sciences has purified immunoglobulin (both SARS-CoV 2 antibodies and existing antibodies) from convalescent plasma of COVID19 individuals and pooled to prepared IVIG formulation to treat severe and critically ill COVID-19 patients. To evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed.

It is intended to assess safety and efficacy of experimental the IVIG treatment in severe and critically ill COVID 19 patients through phase I/phase II randomized single blinded clinical trial with fifty study participants. FDA outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
* Admitted in isolation ward and ICU of institutes affiliated with DUHS
* have severe or critical COVID 19 as judged by the treating physician
* Consent given by the patient or first degree relative

Exclusion Criteria:

* Pregnancy
* Previous allergic reaction to immunoglobulin treatment
* Ig A deficiency
* Patient requiring 2 inotropic agents to maintain blood pressures
* Known case of any autoimmune disorder
* Acute kidney injury or chronic renal failure
* Known case of thromboembolic disorder
* Aseptic meningitis
Effects of Insulin Sensitizers in Subjects With Impaired Glucose Tolerance

Subjects with impaired glucose tolerance will be randomized to receive pioglitazone or metformin for 10 weeks. Measurements of insulin sensitivity, body composition, glucose tolerance, and muscle lipid accumulation will be performed. Adipose tissue and muscle biopsies are performed. The goal of the study is to determine whether the lipotoxiciy of impaired glucose tolerance is ameliorated by pioglitazone.

The progression to type 2 diabetes represents an evolution, which results from a vicious cycle where both glucotoxicity and lipotoxicity act to reduce insulin secretion and insulin action. Lipotoxicity is a new concept, which refers to overaccumulation of lipids in non-adipose tissue reflecting increased free fatty acid delivery. Increased fat content of skeletal muscle and islet cell is associated with insulin resistance and impaired pancreatic -cell function respectively in animal models. Whether lipotoxicity is the link between obesity and diabetes, in humans, and whether reducing intracellular fat content will improve insulin secretion and sensitivity in humans is not known. In this study, we will focus on obese subjects with impaired glucose tolerance (IGT) who have not yet developed glucose toxicity. We will examine insulin secretion, insulin action, hepatic glucose production, and muscle lipid metabolism in response to two insulin sensitizers with two different modes of action. We propose that thiazolidinediones will improve cell function by reversing lipotoxicity as reflective in reduced muscle lipid accumulation.

Hypothesis 1. In subjects with impaired glucose tolerance, who are insulin resistant and also have an insulin secretory defect, thiazolidinediones, but not biguanides, improve cell function.

Hypothesis 2. In subjects with impaired glucose tolerance, thiazolidinediones, but not biguanides, decrease the accumulation of fat in non-adipose tissues including muscle, pancreas, liver and myocardium.

Specific Aim 1. Fifty subjects with impaired glucose tolerance will be recruited and randomized to pioglitazone or metformin treatment

Specific Aim 2. cell function will be evaluated by measuring changes in acute insulin response to glucose and non-glucose secretagogues in subjects with IGT and it will be compared in response to treatment with pioglitazone versus metformin.

Specific Aim 3. The muscle fat content will be evaluated as the surrogate measure for lipotoxicity and overaccumulation of fat in non-adipose tissue. From the muscle biopsy specimens, we will measure the amount of intramyocellular triglyceride before and after treatment with pioglitazone versus metformin.

Specific Aim 4. Adipose tissue cytokine expression is associated with changes in muscle lipid accumulation.

Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance
* Body mass index (BMI) of 28-38

Exclusion Criteria:

* Heart disease
* Renal disease
* Liver disease
Topical Doxepin for Radiation-induced Dermatitis

Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.

The patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. All the patients will be treated by 3D conformal radiation therapy using CT -based treatment planning and multi leaf linear accelerators. The patients will be treated by conventional fractionation regimens to a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week). Every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to RTOG Acute Radiation Morbidity Scoring Criteria which scores from 0 to 4. The patients receive Doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. After acquiring written permission, the radiotherapy site will be photographed at the start and ending of the Doxepin

Eligibility Criteria:
Inclusion Criteria:

* Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy
* Participants must not be pregnant.
* Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week

Exclusion Criteria:

* Patients who are not eligible
* The presence of skin diseases in the radiation area
* Patients have constipation, xerostomia, blurred vision, urinary retention
* Hypersensitivity to doxepin
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline.

The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.


Eligibility Criteria:
Main Inclusion Criteria:

* Informed consent signed and dated
* Patient aged ≥ 18 years old
* Well fitted contact lenses (CL) according to the investigator judgement
* Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study
* Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18
* CLDEQ-8 score ≥ 12

Main Exclusion Criteria:

* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
* Severe blepharitis
* Severe Meibomian gland dysfunction
* Palpebral or nasolacrimal disorders
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Progressive Cervical Isometric Exercises Versus Scapular Stabilization Exercises in Text Neck Syndrome

The aim of this study is to investigate the effects of progressive cervical isometric exercises and scapular stabilization exercises on pain, ROM and disability in young adults with text neck syndrome.

Text neck or Turtle neck posture is the latest term coined by Dr. Dean L. Fishman that demonstrates the repeated stress, injury, and pain in the neck due to having the head in a forward position by excessive use of cell phones or hand-held mobile devices for a prolonged time. The use of mobile devices is becoming a concern especially in children, recent numbers are very alarming and according to surveys 87% of teenagers in America and 79% of teenagers in the UK are mobile phone owners and are greatly affected by them, these numbers have skyrocketed by recent COVID-19 pandemic as the social distancing and closure of the school, colleges and offices have pushed us to work from home and it increases the prevalence of text neck syndrome. This study is unique in that as it investigate the effect of two different treatment plans for turtle neck syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Individuals using mobile phones for more than 6-8 hours.

  * Participants both male and female of age between 18 to 28 years
  * Participants with neck pain (\>7 weeks)
  * Participants with NDI score above 15/50 (10% or higher) or
  * Participants with NPRS score above 3

Exclusion Criteria:

* Specific causes of neck pain (conditions with neurological involvement such as myelopathy with weakness, numbness and sensory loss, cervical disc prolapse, and cervical spinal stenosis)

  * Previous neck and upper limb surgery.
  * History of cervical trauma (whiplash disorder), fractures, dislocations.
  * History of congenital torticollis, frequent migraine, carcinoma, acute pain and inflammation, torticollis, unstable/acute osteoarthritis, any recent fracture, vertigo, vertebrobasilar insufficiency, chronic heart disease, myocardial infarction or pregnancy