cyrilzakka/clinical-trials huggingface dataset:
Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID)

In this study, the investigators will explore the reasons for the apparently lower proportion of severe COVID-19 cases in many sub-Sahara African countries. Indeed, despite fragile health care systems, the burden of COVID-19 on the African continent seems substantially lower than initially feared. Many potential reasons for this discrepancy have been formulated: the different population age structure, experience of African nations with previous pandemics, warmer climate, and genetic preposition. However, another compelling hypothesis is that of trained immunity by endemic pathogens, such as plasmodia. According to this hypothesis, innate immune activation by endemic pathogens would prime a more robust initial innate immune response to SARS-CoV-2 and could therefore protect against severe COVID-19.

To explore this, the investigators propose conducting a case-control study in Kinshasa, in the Democratic Republic of the Congo (DRC). Kinshasa is an area with mixed prevalence of malaria and the area in DRC most affected by COVID-19. In this setting, the investigators will compare cases of severe COVID-19 with controls that have non-severe COVID-19 and that are matched for age, sex, and health zone. The aim is to compare pre-existing immunity against malaria, both cellular and humoral between the two groups.


Eligibility Criteria:
INCLUSION CRITERIA

To be eligible, study patients must meet the following criteria:

For cases:

* Be at least 18 years of age
* Have an RT-PCR or Antigenic Rapid Test confirmed SARS-CoV-2 infection within 72 hours prior to inclusion.
* Have given informed consent or that of their guardian/ representative to participate in the study.
* Diagnosed as a severe COVID-19 case according to the following criteria:

  * Presenting clinical signs of pneumonia: fever, cough, dyspnea or crepitations AND
  * Presenting at least one of the following signs:

Respiratory rate \> 30 cycles/min OR Severe respiratory distress or SpO2 \< 90% on room air

* Be admitted to a care unit for COVID-19
* Residing in the health zone for at least 6 months

For controls:

* Be at least 18 years of age
* Have a PCR or Antigenic Rapid Test-confirmed SARS-CoV-2 infection within 72 hours prior to inclusion
* Have given informed consent to participate in the study
* Diagnosed as a non-severe COVID-19 case according to the following criteria:

  * Be asymptomatic OR
  * Symptomatic, but no evidence of severe pneumonia Respiratory rate \> 30 cycles/min OR Severe respiratory distress or SpO2 \< 90% on room air
* Reside in the study health area for at least 6 months
* Recruited within 10 weeks following the matched cases

EXCLUSION CRITERIA

To be eligible, study patients cannot meet the following criteria for cases and controls:

* Subject has a contraindication to venipuncture, as determined by clinical judgment
* Subject is vaccinated against SARS-CoV-2
* Subject has been infected with SARS-CoV-2 in the past and now presents with reinfection
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.


Eligibility Criteria:
Inclusion Criteria:

* The subject requires primary skin grafting as a result of an acute thermal burn injury
* The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
* The area of total burn injury is 1-20% TBSA
* The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
* The study treatment area is a second degree burn injury
* The subject is between 18-65 years of age
* The subject is willing to complete all follow-up evaluations required by the study protocol
* The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary
* The subject agrees to abstain from enrollment in any other clinical trial for the duration of the study
* The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent
* The subject is able and willing to follow the protocol requirements

Exclusion Criteria:

* The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
* The total subject burn injury is less than 1% or more than 20% TBSA
* The subject has a microbiologically proven pre-existing local or systemic bacterial infection
* The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
* The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
* The subject is unable to follow the protocol
* The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
* The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
* The subject has a known hypersensitivity to Trypsin or Compound sodium Lactate for Irrigation (Hartmann's) solution
Comparison of Different Portable Tonometers (Icare Pro, TONO-Pen AVIA, Perkins Tonometer, PASCAL Hand Held Dynamic Contour Tonometer)

In different cases intraocular pressure (IOP) have to measured in lying position. Therefore a lot of portable tonometers have been established. The Icare Pro is a new tonometer on the market that allows faster and more comfortable IOP-measurements. No local anesthesia is needed, what is a major advantage for the patients. In this study the investigators want to evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer).

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* healthy patients of at least 18 years of age or above

Exclusion criteria:

* diagnosis of glaucoma or other optic neuropathies
* corneal disorder that make IOP measurement impossible
The Use of Cyanoacrylate on Palatal Wound

The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.

A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate.

Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.

Eligibility Criteria:
Inclusion Criteria:

* no systemic diseases
* no coagulation disorders
* no drug intake in the previous 6 months that might effect the periodontal health status
* no pregnancy or lactation
* no smoking habit
* \<1 mm attached gingiva width on one or two lower anterior teeth
* Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)

Exclusion Criteria:

* Hematologic disorders
* No cooperation
Post Market Registry of the CBSO

Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use


Eligibility Criteria:
Inclusion Criteria:

* Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
* Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
* A CBSO is implanted into the patient.

Exclusion Criteria:

* Patient is known to have one or more of the contraindications listed in the instructions for use.
* Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
* Patient is implanted with another product in the atrial septum.
Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.


Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis
* secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion Criteria:

* inflammatory arthritis
* hip joint infection
Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)

To assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history taking(defined in this study as case history taking type I and II).

Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the taking of the case history and the prescription of an individually selected homeopathic remedy. Homeopathic medicines are produced through sequential, agitated dilutions. A Q-Potency is prepared by grinding the raw material, followed by a process of consecutive 1:50.000 agitated dilutions.

Previous data suggest that individualized homeopathic Q-potencies were non inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe major depression. The question remains whether individualized homeopathic Q-potencies have a specific therapeutical effect in acute depression as this has not yet been investigated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of major depression by a psychiatrist,
* patients must not be currently taking antidepressants or anxiolytic drugs (with the exception of Lorazepam as rescue medication, maximal dose 1.5 mg/day)
* Capability and willingness to give informed consent and to comply with the study procedures will also be required

Exclusion Criteria:

* current mild episode of depression (HAM-D \< 17)
* current severe episode of depression (HAM-D \> 24)
* schizophrenia or other psychotic disorders
* bipolar affective disorder
* schizoaffective disorders
* alcohol or other substance abuse
* eating disorders
* a clinically significant (Diagnostic and Statistical Manual of Mental Disorders)-Axis II disorder
* severe depression, which previously motivated a suicide attempt
* a score of 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS)up to three months before screening;
* a clinically significant acute or chronic disease that would hinder regular participation in the study
* treatment with antipsychotics, antidepressants, sedatives/hypnotics or mood stabilizers four weeks prior to the screening
* complementary or alternative treatment simultaneously to the study (for example, acupuncture, phytotherapy, etc.)
* homeopathic treatment eight weeks prior to study entry
* psychotherapy
* simultaneous participation in another clinical trial (the last participation in a previous clinical trial must be completed at least three months prior to screening)
* concomitant pregnancy or breastfeeding
* patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical trial and for not complying with the necessary study procedures
* persons who have been institutionalized by a court order
* patients with an application for a pension
Physiologic Variables in Healthy Women in Shuttle Walk Test

To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle Walk Test, verify the distance reached and interruption causes of the test.

The Shuttle Walk Test requires patients to walk at a gradually increasing speed, up and down a 10 meter corridor identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.

Eligibility Criteria:
1. Inclusion criteria:

   1. female gender;
   2. sedentary;
   3. aged 20 to 30 years.
2. Exclusion criteria:

   1. pregnancy;
   2. enrolment in any regular physical activity program;
   3. diagnosed health conditions.
Evolution® Biliary Stent System-Fully Covered

The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent

Exclusion Criteria:

* \< 18 years of age
* Unwilling or unable to sign and date the informed consent
* Unwilling or unable to comply with the follow-up schedule
* Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
* Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
* Endoscopic procedures are contraindicated
* Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
* Presence of a metal biliary stent
* Presence of an esophageal or duodenal stent
* Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
* Coagulopathy
* Diffuse intrahepatic metastases that involves \> 10 % of the liver
* Life expectancy of \< 3 months
* Pregnant
* Active alcohol or substance abuse issue
* Jaundice secondary to a cause other than biliary duct obstruction
* Additional endoscopic restrictions as specified in the Clinical Investigation Plan
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)

This is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors \>55 years old with chemotherapy \>5 years ago.

The overall goal of this study to identify the feasibility and value of risk-guided cardiac rehabilitation (exercise, risk factor modification, and behavioural support) as a component of survivorship care.

Participants enrolled in this study will be randomized to cardio-oncology disease management plan ( CO-DMP) that involves the use of surveillance imaging to detect subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise/sedentariness intervention. The intervention will be delivered over a period of 6 months. Usual care patients will then cross over the CO-DMP for 6 months. The outcome from this study will show that subclinical LVD is more common among long term cancer survivors, and a CO-DMP is feasible in reducing HF risk factors in this sub group of survivors.

Eligibility Criteria:
Inclusion Criteria:

1. History of cancer \> 10 years ago
2. Have received potentially toxic chemotherapy Anthracycline (any dose) Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR Tyrosine kinase inhibitors (e.g. sunitinib) OR Left chest radiotherapy

Exclusion Criteria:

1. Ejection fraction at baseline echo \<50%
2. Valvular stenosis or regurgitation of \>moderate severity
3. History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2)
4. Systolic BP \<110 mmHg
5. Pulse \<60/minute if not on beta blocker
6. Inability to acquire interpretable images (identified from baseline echo)
7. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
8. Oncologic (or other) life expectancy \<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
9. Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
10. Unable to provide written informed consent to participate in this study
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
* Male, or female and meets all the following criteria:

  1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
  2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
* Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria:

* Is expected to require or undergo treatment with any exclusionary medication.
* Is undesirable as a study participant as judged by the investigator
[14 C] Study on Mass Balance of TY-9591 in Healthy Chinese Subjects

\[14 C\] Mass balance clinical trial of TY-9591 in healthy Chinese subjects

This is a single-center, non-randomized, one-arm, open trial in healthy adult subjects. The study population is male healthy subjects. The trial consisted of a screening period, a trial period and a follow-up period. A total of 6-10 healthy Chinese adult male subjects were planned to be enrolled and divided into groups according to specific conditions.

Eligibility Criteria:
Inclusion Criteria:

* 1. Be at least 50.0 kg in weight, and have a body mass index (BMI) in the range of 18.0-30.0 \[BM= weight (kg)/ height 2(m)\] (including the critical value.

  2.Subjects were sterile themselves, or voluntarily took highly effective non-drug contraception or abstained from sex completely from the beginning of self-medication to 1 year after administration.

  3.Volunteer to participate and sign informed consent, be able to communicate well with the investigator and complete the investigator in accordance with the study regulations.

Exclusion Criteria:

* 1.After a thorough physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation function). Urine routine, stool routine + occult blood), anal digital examination, thyroid function, 12-lead electrocardiogram, chest X-ray (positive position), abdominal color Doppler ultrasound, liver, bile, pancreas, spleen and kidney) and other tests with clinical significance.

  2.Abnormal ophthalmic examination (intraocular pressure, slit lamp, fundus film) with clinical significance.

  3.Test positive for either hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibo.

  4.Those who smoked more than 5 cigarettes a day or habitually used nicotine products in the 3 months before screening, or were unable to abstain during the trial.

  5.A history of severe diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and bone system, or any other disease or physiological condition that may affect the results of the study.

  6.Who participated in any drug clinical trial as a subject within 3 months prior to the administration of this trial.

  7.Those who had taken any prescription, over-the-counter, herbal and health products in the 14 days prior to screening.

  8.Those who cannot tolerate venous puncture blood collection or fainting blood or fainting needle.

  9.Those who have special dietary requirements and fail to follow the diets and regulations provided.

  10.The investigator considers it inappropriate to participate in clinical trials or is otherwise unable to complete the study.