cyrilzakka/clinical-trials huggingface dataset:
Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana

In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.

Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.

The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3-59 months
* Care giver or parent willing to participate and have given informed consent
* Children living in the study area

Exclusion Criteria:

* Children who are unable to take and retain medication
* Children who have a severe or chronic illness
* Children who have a history of serious adverse reaction to the study drugs
Effects of Respiratory Muscle Training on Pulmonary Function

The study was conducted to determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain. It included 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. It concluded that RMT in addition to conventional physiotherapy is effective to improve musculoskeletal and pulmonary parameters in CNP patients.

To determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain.

Study design: A randomized controlled trial Place and Duration of Study: Riphah Rehabilitation and Research Center in Railway General Hospital and Benazir Bhutto Hospital, Rawalpindi from January 2019 to July 2019.

Methodology: 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. They were assessed prior to, at 2nd week and after 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* . Patients having non-specific chronic neck pain with or without headache for more than three months with pain complaints at least once a week 2. Males and females both of age 20 to 40 years old 3. Patients with low maximum voluntary ventilation (MVV) values i.e., less than 110 L/min in males and 80 L/min in females

Exclusion Criteria:

* Patients already participating in physiotherapy program 2. Patients with past history of

  * surgery to the cervical spine
  * traumatic cervical injuries
  * clinical abnormalities or surgeries of the thoracic cage or vertebral column
  * severe obesity (BMI\>40)
  * pregnancy
  * smoking history/occupational industrial exposures
  * chronic neuro-musculoskeletal pain in any other non-related body area
  * respiratory or cardiac illness, diabetes mellitus and serious comorbidities
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis

The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.

The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* patients must be able to give informed consent preoperatively
* ASA I-III
* patients at high risk to have CBD stones (jaundice, cholangitis, grossly deranged LFTs, CBD stones found on US or MRCP)

Exclusion Criteria:

* patients not fit for surgery (ASA IV)
* previous ERCP and sphincterotomy
* previous upper abdominal surgery
* pregnancy at time of surgery
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy

The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg


Eligibility Criteria:
* Inclusion Criteria:

  * Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:

    * Naïve : 140 mmHg ≤ SiSBP \< 180 mmHg
    * Use antihypertensive drugs : 130 mmHg ≤ SiSBP \< 180 mmHg
  * Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:

    * Selected reference arm : 140 mmHg ≤ SiSBP \< 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP \< 180 mmHg)
    * Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)
  * Voluntarily provided a written consent to participate in this clinical study
  * Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
* Exclusion Criteria:

  * Patients taking three or more antihypertensive drugs of different families
  * Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)
  * Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
  * Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Patients with orthostatic hypotension accompanied by symptoms
  * Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.

A RC for survivors of head and neck cancer (HNC) was developed in collaboration with an Advisory Panel that includes survivors, family members, health care professionals, and health system representatives. This phase of the study aims to conduct a pilot evaluation of the RC using a mixed method, single group study with a convenience sample of approximately 35 survivors of HNC post primary cancer treatment, recruited from the Princess Margaret Cancer Center HNC clinics. In addition to the RC intervention, participants will be required to attend 3 research assessments (pre intervention, post intervention, and 1 month follow-up) that are a combination of face-to-face visits and telephone calls.

Quantitative data analysis will be exploratory and descriptive, and effect sizes will be calculated for all outcomes to help plan for a future, controlled trial. Means, standard deviations, and Cohen's d effect size will be calculated for normally distributed data. For non-normally distributed data, medians, ranges, and a nonparametric effect size r will be calculated. For qualitative analysis, all interviews will be audio recorded, transcribed verbatim, and analyzed using a two-phased, hybrid approach that is both deductive and inductive. Findings will be summarized and reported to the Advisory Panel, who will then make recommendations regarding any additional modifications to the RC. The research team will make final decisions about RC modifications and will finalize a version for future evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.

Exclusion Criteria:

* Lack of English fluency,
* Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and
* Known active cancer.
CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors

This study is a clinical study of CD276 CAR-T in the treatment of patients with advanced solid tumors. The purpose is to evaluate the safety and effectiveness of targeting CD276 auto-chimeric antigen receptor T cells in the treatment of CD276-positive advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age 3-70
* Expected survival time ≥ 12weeks
* ECOG 0-2
* At least second-line or above chemotherapy failed
* According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion (non-nodular lesion with longest diameter ≥10mm, or nodular lesion with short diameter ≥15mm)
* Liver and kidney function, heart and lung function meet the following requirements:

  1. Creatinine is within the normal range;
  2. Left ventricular ejection fraction ≥ 45%;
  3. Baseline blood oxygen saturation\>91%;
  4. Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
* Understand the trial and have signed the informed consent

Exclusion Criteria:

* Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
* Severe heart disease
* Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
* Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
* Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 1 year after cell reinfusion, or male subjects whose partners plan to become pregnant within 1 year after cell reinfusion
* Those who have received CAR-T therapy or other genetically modified cell therapy before screening
* Subjects who are receiving systemic steroid therapy at the time of screening and the investigator determines that they need long-term systemic steroid therapy during the treatment period (except for inhaled or topical use)
* Participated in other clinical studies within 3 months before screening
* Central nervous system metastases are known to occur and for suspected central nervous system metastases, head MRI examination is required to rule out
* Patients with partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved by active treatment
* With more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase
* According to the researcher's judgment, it does not meet the situation of cell preparation
* Situations that other researchers think are not suitable for inclusion
Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique

Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.

To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.

Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.

Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.

Eligibility Criteria:
Inclusion Criteria:

* 50% stenosis (NASCET) or more based on CTA (CT-angiography),
* MRI or US,
* Scheduled for CEA
* 50 years or older,
* Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).

Exclusion Criteria:

* Contraindications to iodine contrast media,
* Contraindications to MRI or gadolinium contrast media.
Test-Retest Variability of Quick Contrast Sensitivity Function Testing

The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial vision and predicts functional vision better than visual acuity, but long testing times prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010) developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a computerized software program that presents letters on a large monitor that are identified by a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is only about 3-6 minutes. Some preliminary testing has been performed at other sites with this test in patients with vision loss due to amblyopia and glaucoma, but data from individuals without eye disease who have normal visual acuity has not been systematically collected with the latest version of this test procedure across a wide range of ages. In addition, we aim to gain a better understanding of the typical test-retest variability that is obtained between-sessions that are about a week apart from individuals with good ocular health and visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Ages 20-89
* Normal distance visual acuity in each of both eyes (20/20)
* Absence of ocular disease
* Able and willing to complete contrast sensitivity testing
* Provide informed consent

Exclusion Criteria:

* Any ocular disease
* Refractive errors \>6D
* Inability to understand study or communicate responses (cognitive impairment)
* Unable to understand, read and speak English fluently
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.

OBJECTIVES:

* To identify TAB3 transcript/protein as a molecular marker of cancer, specifically testicular, skin, small intestine, and pancreatic cancer.
* To characterize TAB3 and its signaling networks that are involved in tumorigenesis.

OUTLINE: Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Paraffin tissue blocks from surgical pathology cancer cases, specifically testicular, skin, small intestine, and pancreatic cancer, available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization

The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.

The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.


Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.
* Ages from 18 to 75,male or female.
* Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.

Exclusion Criteria:

* Subjects who had significant defect in the corneal epithelium.
* Study eye had been injected of anti-vegf drugs within 3 months before screening
* Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.
* Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)
* Systemic use of anti-vegf drugs within 45 days prior to screening.
* Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants（except aspirin）.
* Uncontrolled clinical problems such as canner etc..
* Unable or unwilling to use effective contraception.
* Positive blood tests for pregnancy (female subjects)
* Participated in drug clinical trials within 3 months before the first administration.
* The researchers think the participants were not suitable for this trail.