cyrilzakka/clinical-trials huggingface dataset:
Western Kenya Integrated COVID-19 Response

To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.


Eligibility Criteria:
Inclusion Criteria:

* Youth aged 18 to 30 years old.
* Active community health workers.
* Facilities with oxygen capacity.

Exclusion Criteria:

* Individuals younger than 18 or older than 30 years old.
* Inactive community health workers.
* Facilities without oxygen capacity.
The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain

the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group.

Hypothesis:

The hypothesis of this study states that:

o Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP


Eligibility Criteria:
Inclusion Criteria:

* Only male patients will be included.
* Age 20-40 years old.
* Non-specific LBP for at least 3 months.
* At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
* Pain intensity on numerical pain scale should be more than 4

Exclusion Criteria:

* LBP due to a pathology or trauma.
* Below 20 years of age.
* Previous lumbar surgeries.
* Malignancy.
* Patients under medications or painkillers.
Gastric Restriction Using the EndoSurgical Operating System

The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
* Patient is \>/= 20 yrs. of age and \</= 60 yrs. of age
* Patient has a BMI of \>/=30 and \< 40
* Patient has history of obesity for \>/= 2 yrs.
* Patient has had not significant weight change (\<5% of total body weight) in last 6 months.
* Patient is a reasonable candidate for general anesthesia
* Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.

Exclusion Criteria:

* Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
* Patient is not able to provide written informed consent
* Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
* Patient has diabetes secondary to a specific disease.
* Patient has history of inflammatory disease of GI tract
* Patient has diabetic retinopathy
* Patient has chronic pancreatic disease
* Patient ahs active peptic ulcer
* Patient has portal hypertension
* Patient has esophageal varices
* Patient has significant esophageal disease
* Patient has a history of any significant abdominal surgery
* Patient has a history of any bariatric or GERD surgical procedures
* Patient has a hiatal hernia \> 2cm.
* Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
* Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
* Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
* Patient has cancer or life expectancy of \< 2 yrs.
* Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
* Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
* Patient has a history of durg or alcohol abuse
* Patient has uncontrolled depression, psychosis, or eating disorder.
* Patient is non-ambulatory or has significant impairment of mobility.
* Patient has known hormonal or genetic cause for obesity.
* Patient is participating in another Registry and/or Study that could adversely affect this Registry.
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old,
2. Signed consent to participate,
3. Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
4. Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
5. Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
6. immediate breast reconstruction by autologous latissimus dorsi flap
7. immediate breast reconstruction by latissimus dorsi flap and prosthesis,
8. secondary breast reconstruction by latissimus dorsi flap
9. Affiliation to, or beneficiary of, a social security scheme.

Exclusion Criteria:

1. Patient under 18,
2. Pregnant woman or likely to be (without effective contraception) or breastfeeding,
3. Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
4. Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
GAIN Project: Gastric Cancer and Artificial Intelligence

Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.

The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).


Eligibility Criteria:
Inclusion Criteria:

* All \>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications in Italian areas at high-risk of gastric cancer (Lombardia, Emilia Romagna, Veneto, Friuli-Venezia Giulia).

Exclusion Criteria:

* contraindications to upper-GI endoscopy.
* contraindications to biopsy.
* active upper-GI bleeding or urgent upper-GI endoscopy.
* patients with previous upper-GI surgery involving the stomach.
* patients who were not able or refused to give informed written consent.
Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study

The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP joint ligamento-muscular reflexes and their role is.

Encapsulated nerve endings called mechanoreceptors are end components of afferent nerves and have specialized end organs surrounding the nerve terminal. Those receptors are concentrated in various human periarticular tissues. It is believed that these mechanoreceptors in the periarticular tissues are related to muscle reflexes. However, it is still unknown which type of mechanoreceptors contribute to the muscle reflexes and whether the mechanoreceptors excite and/or inhibit muscle activation. In the investigators previous studies, mechanoreceptors in the human proximal interphalangeal (PIP) joint and surrounding structures have been extensively examined. The investigators have identified that Pacini-like nerve endings in the PIP joint were found in substantial numbers in the junction of the C1 pulley and accessory collateral ligaments. The investigators hypothesize that the Pacini-like nerve endings in the junction of the C1 pulley generate activity in the associated flexor muscle/tendon in the finger.

Eligibility Criteria:
Inclusion criteria:

- Females aged 20-30

Exclusion criteria:

* A history of any upper extremity injury or disorder in the non-dominant arm
* A history of any neurologic or bleeding disorder, or taking blood-thinning medication.
* Presence of Linbug-Comstock syndrome
Timing of Closure of Patent Foramen Ovale Following Birth

It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.

We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.

Eligibility Criteria:
Inclusion Criteria:

* any baby born in term and with normal delivery

Exclusion Criteria:

* sick newborns in need of neonatal intensive care for any medical reason.
* newborns with congenital heart disease except for small, muscular ventricular septal defects
A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma

The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).


Eligibility Criteria:
Inclusion Criteria:

* Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
* For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of the extremities, Grade 2 or 3, \>5 centimeters, for which olaratumab and radiotherapy would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid liposarcoma will be excluded.
* Have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling.

Exclusion Criteria:

* Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
* Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
* For radiotherapy addendum only: Have received previous radiotherapy in the primary tumor lesion and/or prior treatment with olaratumab or has participated in a prior olaratumab trial.
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors

The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor \[G-CSF\] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10\^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
* At least a 14-day period from end of last dose of chemotherapy received
* Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1

Exclusion Criteria:

* Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
* Hematological malignancies
* Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
* History of seizure disorder
* Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) \> class II, or uncontrolled hypertension
* Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
* Specified concomitant medications
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Elevated liver enzymes (AST/ALT) \> 2.5 x ULN, or \> 5.0 x ULN if secondary to liver metastases; alkaline phosphatase \> 2.5 x ULN or \> 5.0 x ULN if secondary to liver or bone metastases; total bilirubin \> 1.5 x ULN
* Radiation therapy within 14 days of study day 1
* Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
* Concurrent radiation therapy is not permitted throughout the course of the study
A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

The purpose of this study is to assess the effects on placebo-corrected change from baseline QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered subcutaneously once weekly.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25.0 and 40.0 kilogram per square meter ( kg/m\^2), inclusive, and a body weight of not less than 80 kg
* Blood pressure (BP) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (from screening through Day 56) or until 30 days after the last dose of study drug for participants that withdraw early from the study
* QRS interval of less than or equal to (\<=) 110 milliseconds (ms)
* An average of triplicate 12-lead safety electrocardiogram (ECG) recording, completed within 4 minutes total, consistent with normal cardiac conduction and function at screening, including

  1. Normal sinus rhythm (heart rate between 45 and 100 beats per minute \[inclusive\])
  2. QT interval corrected for heart rate according to Fridericia's formula (QTcF) interval between 350 to 450 ms (inclusive)
  3. PR interval \<= 200 ms
  4. ECG morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

* Taken any disallowed therapies as defined in a protocol before the planned first dose of study drug
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram at screening or at admission to the study site
* Known allergies, hypersensitivity, or intolerance to JNJ-64565111, moxifloxacin, or its excipients
* Hepatitis B or C infection
* History of additional risk factors for torsade de pointes or the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<= 40 years), or sudden infant death syndrome in a first-degree relative (that is biological parent, sibling, or child)
Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

The purpose of this study is to assess and contrast the effectiveness of intravenous ondansetron and intravenous hydrocortisone in avoiding spinal anesthesia-induced hypotension.

According to the medication investigated in this study, patients will be divided into three equal groups (40 each). Patients will receive one of the following 15 minutes before spinal anesthesia:

1. Hydrocortisone 100 mg (H group)
2. Ondansetron 8 mg (O group)
3. An identical volume of sterile distilled water (Control group) (C group).

Spinal anesthesia will be performed under complete aseptic conditions with the patient seated, a 25-gauge Quincke spinal needle is used to administer 3.5 ml of a 0.5% hyperbaric bupivacaine together with 25 micrograms of fentanyl at the L3-L4 or L4-L5 level.

Patients will lie supine with slight head elevation after the intrathecal injection is finished. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 30 min during which the patient remains in the supine position with no application of torniquet.

If the MAP drops by 20% below baseline or the systolic blood pressure falls below 90 mmHg, hypotension is recorded and will be treated with intravenous incremental doses of 5 mg ephedrine.

If the heart rate drops below 50 beats per minute, bradycardia is recorded, and atropine 0.5 mg will be administered intravenously. If ephedrine or atropine were used, only data from before their administration would be analyzed. The doses of ephedrine and atropine needed will be recorded.

Nausea, vomiting and shivering will be recorded when occur till the end of operation.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I and II (physical status according to American Society of Anesthesiologists).
2. Patients aged 21 years or more.
3. Either sex.
4. Abdominal and lower limb operations.

Exclusion Criteria:

1. Patient refusal.
2. hemodynamic instability
3. Hematological diseases, bleeding or coagulation abnormality.
4. Local skin infection and sepsis at site of spinal anesthesia
5. neuromuscular diseases (as myopathies, myasthenia gravies...)
6. Preexisting neurological deficit or psychiatric diseases.
7. Known intolerance to the study drugs.
8. patients already receiving any of the study drugs.
9. diabetic patient.
Cytokine Adsorption in Lung Transplantation

Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality (2). PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival.

The present study is a randomized controlled pilot study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.

Early intolerance to the newly transplanted lung starts at the time of transplantation and results in PGD driven by an intense inflammatory response. Cytokines play a critical role as signaling molecules that initiate, amplify, and maintain inflammatory responses both locally and systemically. The use of cytokine filtration devices to target middle- and low-molecular weight molecules has been shown to reduce levels of a diverse number of cytokines. These results have been demonstrated in the in vitro reduction of pathogen-associated molecular pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine adsorption has been used successfully in clinical applications to both heart and kidney transplantation.

The present study is a randomized controlled pilot study which aims to collect preliminary data on the efficacy of a medical device through the comparison of patients undergoing LTx with and without cytokine adsorption.

Eligibility Criteria:
Inclusion Criteria:

* Double lung transplantation
* Single organ failure

Exclusion Criteria:

* Re-transplantation
* Drug abuse
* Kidney failure
* Liver failure
* Diabetes mellitus