cyrilzakka/clinical-trials huggingface dataset:
A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

This is a Phase 1/2 study of HST-1011, a CBL-B inhibitor, being developed for the treatment of patients with advanced solid tumors, who relapsed while on or are refractory to approved anti-PD(L)1 therapies or other standard of care.

This is a Phase 1/2 study of HST-1011, a CBL-B inhibitor, being developed for the treatment of patients with advanced solid tumors, who relapsed while on or are refractory to approved anti-PD(L)1 therapies or other standard of care.

In Phase 1 patients will receive HST-1011 as either monotherapy (Parts A1 and A2) or in combination with the anti-PD1 antibody, cemiplimab (Part B1 and B2).

Part A1 is a monotherapy dose escalation in which cohorts of patients will receive increasing doses of HST-1011. Upon completion of Part A1 dose escalation, an HST-1011 monotherapy dose optimization will commence (Part A2).

Part B1 is a dose escalation of HST-1011 given in combination with the standard dose/regimen of cemiplimab. Dosing in Part B1 may commence prior to the completion of Part A1. Upon completion of Part B1 dose escalation, an HST-1011 dose optimization in combination with cemiplimab will commence (Part B2).

Phase 2 will evaluate the preliminary antitumor activity of HST-1011 in combination with anti-PD(L)1 antibody or other standard of care therapies.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is capable of understanding and complying with protocol requirements.
* Patient has signed and dated ICF.
* Patient has a histologically confirmed, advanced solid tumor (metastatic, recurrent, and/or unresectable) in one of the following categories: 1) anti-PD-(L)1 relapsed/refractory; 2) platinum-resistant ovarian cancer; 4) anal cancer; 5) rectal cancer; or 6) castration-resistant prostate cancer
* Patient has failed prior standard of care therapies appropriate for their metastatic disease.
* Patient has at least 1 measurable non-central nervous system (CNS) lesions per RECIST 1.1.
* Patient has provided consent for pre- and on-treatment biopsies.
* Eastern Cooperative Performance Status of 0 or 1.

Key Exclusion Criteria:

* Patient has active autoimmune disease or other medical conditions requiring chronic systemic steroid therapy at the time of screening.
* Patient has an unacceptable intolerance to anti-PD-(L)1 monoclonal antibody (Part B Only).
* Patient has previously participated in a clinical study evaluating a CBL-B inhibitor.
* Patients has untreated and/or symptomatic metastatic CNS disease.
* Patient is currently taking any concomitant medications at Screening that have the potential to cause a clinically relevant drug-drug interaction with HST-1011.
* Patients with a history of gastrointestinal disease that may affect absorption of the study drug, or patients who are not able to take oral medications.
* Patient has an active infection requiring systemic therapy.
* Patient has known or suspected infection with SARS-CoV-2 virus.
Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than \<1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.

We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis or septic shock at admission or during the stay

Exclusion Criteria:

* Minor
* Pregnancy
* Opposition
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 (\[KMT2A1\], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).


Eligibility Criteria:
Inclusion Criteria:

* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
* Performance status greater than or equal to (\>=) 50 by lansky scale (for participants less than \[\<\] 16 years of age) or \>=50 percent (%) karnofsky scale (for participants \>=16 years of age)
* Estimated or measured glomerular filtration rate \>= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2) based on the bed side schwartz formula

Exclusion Criteria:

* Received an allogeneic hematopoietic transplant within 60 days of screening
* Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
* Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
* Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
* Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
* Prior exposure to menin-KMT2A inhibitors
* Prior cancer immunotherapy (ie \[that is\], Chimeric Antigen Receptor-T Cell Therapy \[CAR-T\], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes

Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosed type 2 diabetes at least for six months;
2. Both genders;
3. Aged between 50 and 80 years old;
4. Non-smokers;
5. Not engaged in supervised exercise;
6. Community-dwelling;
7. Medical recommendation for lifestyle intervention;
8. Known medical history;
9. Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy;
10. No cardiovascular, respiratory and musculoskeletal contraindications to exercise;
11. No gait and balance problems;
12. Not taking insulin or sulfonylureas for less than three months;
13. Volunteer participation with signed informed consent.

Exclusion Criteria:

1. Participation in another supervised exercise program during the study;
2. Participation in another supervised dietary intervention during the study;
3. Aggravation of a diabetes complication or another major health problem;
Impact of Alternative Treatment Strategies and Delivery Systems for Soil-transmitted Helminths in Kenya

The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.

The study will be conducted in two settings of Kenya that have contrasting epidemiological and programmatic characteristics, Kwale County on the south Kenyan coast and Bungoma County in western Kenya. Allocation to study group will be by cluster, using predefined units used in public health provision - termed Community Units (CUs), which comprise approximately 1,000 households or 5,000 people. CUs will be randomized to one of three groups, receiving either (i) annual school-based deworming; (ii) annual community-based deworming; (iii) biannual community-based deworming. In nine CUs, a longitudinal study will be conducted in order to better understand the transmission dynamics of STH.

Eligibility Criteria:
Inclusion Criteria:

* Usual resident of study community or student enrolled in study school;
* Willingness of adult aged 18 years and above or parent/guardian to provide written informed consent;
* Provision of written assent to participate from children aged 8 years and above.

Exclusion Criteria:

* Visitor to household at time of household visits;
* Refusal of informed consent;
* Refusal to assent by children aged 8 years and above.
To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).


Eligibility Criteria:
Inclusion Criteria:

* Male patients who have completed family planning or female patient, aged 40 years or older
* Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
* Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
* Able to walk at least 150 meters during the 6MWT at screening
* Resting oxygen saturation of ≥89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
* FVC ≥45% predicted of normal
* Ratio of forced expiratory volume in the first second (FEV1) to FVC ≥0.7
* Diffusing capacity for the DLCO corrected for hemoglobin ≥30% predicted of normal
* Absence of IPF improvement in the past year, as determined by the investigator
* Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone

Exclusion Criteria:

* Unable to perform spirometry as per ATS
* Evidence of IPF exacerbation within 3 months prior to and/or during screening
* Evidence of emphysema extent greater than the extent of fibrosis
* Current smoker (tobacco, e-cigarette)
* History of lung transplant or lung volume reduction surgery
* Current immunosuppressive condition
* Estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator
* Congestive heart failure class III or IV according to New-York Heart Association classification
* Pulmonary hypertension (PH) requiring PH specific therapy
* Unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period
* Use of other medications likely to interfere with study assessments
* Any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results
Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm

Best treatment option of retinal arterial macroaneurysm is still controversial. A recent publication has shown that subthreshold laser treatment can be beneficial in improving visual acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is to compare the effects of subthreshold laser treatment and threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

The treatment of RAM is controversial and at present there is no general consensus about the best approach. Spontaneous obliteration of RAM may occur over the follow-up, but the long persistence of blood or subretinal fluid may lead to progressive photoreceptor damage, with consequent irreversible visual impairment. More specifically, the presence of subretinal hemorrhage beneath the fovea leads to a diminished visual function.

Treatment is generally indicated for RAM associated with exudative manifestations involving the fovea which do not tend to resolve spontaneously. The most commonly employed approach is direct or indirect laser photocoagulation with visible end-point. Nevertheless, several complications may be associated with conventional threshold laser for macular lesions, including enlargement of laser scar, choroidal neovascularization, and subretinal fibrosis. In addition to these complications, arteriolar obliteration, increased retinal exudation and scarring, with possible retinal traction, have also been reported as possible sequelae of the laser photocoagulation of RAM.

Another approach for the treatment of RAM is based on the use of subthreshold laser treatment.

Subthreshold laser treatment has been proposed in an attempt to minimize the negative aspects of conventional grid laser photocoagulation and has achieved encouraging results, especially in macular oedema secondary to diabetic retinopathy, proliferative diabetic retinopathy, and branch retinal vein occlusion. The concept underlying the use of subthreshold laser treatment is to decrease the laser damage by reducing the duration of laser exposure and by using a subvisible clinical end point. A micropulse diode laser releases low energy micropulses in order to confine the energy to the RPE cells, with limited protein denaturation, avoiding lateral thermal spreading.

Aim of the study is to compare the effects of subthreshold laser treatment to those of threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

Eligibility Criteria:
Inclusion Criteria:

* Retinal arterial macroaneurysm, exudative manifestations involving the fovea (including: subretinal/intraretinal fluid, and/or hard exudates, and/or hemorrhages), best corrected visual acuity worse than 20/80 Snellen equivalent, corresponding to 0.6 LogMAR

Exclusion Criteria:

* previous treatments for retinal arterial macroaneurysm, any other ocular disease
Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.


Eligibility Criteria:
Inclusion Criteria:

* patients with relapsed or refractory chronic lymphoproliferative disorders
* salvage treatment with bendamustine +/- rituximab
* age ≥ 18 years

Exclusion Criteria:

* previous treatment with bendamustine
Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.

The clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome.

This study prospectively studied the treatment of acute drug-induced liver injury related to anti-tumor with bicyclol tablets, to provide medical evidence in clinical practice of bicyclol treating acute drug-induced liver injury. The main purpose of this study is to evaluate the clinical efficacy and outcome of bicyclol tablets in the treatment of drug-induced liver injury and analyze the bicyclol tablet's therapeutic effects in different groups including conventional chemotherapy drugs, targeted drugs, and immunosuppressants. The secondary purpose of this study is to analyze the factors influencing the prognosis and outcome of bicyclol tablets in the treatment of acute DILI.

Eligibility Criteria:
Inclusion Criteria:

1. The acute liver injury caused by anti-tumor drugs
2. The RUCAM assessment scale ≥6
3. The liver injury must in the acute phase
4. Must be treated with bicyclol tablets
5. Must sign informed consent -

Exclusion Criteria:

1. This acute liver injury caused by non-anti-tumor drugs
2. Pregnant women
3. Lactating women
4. Childbearing age women are plan to conceive
Correlation Between Missing Posterior Teeth and Vertical Dimension Measurements With Temporomandibular Joint Disorders in a Sample of Adult Egyptian Subjects

The goal of this observational study is to learn about the correlation between missing posterior teeth and vertical dimension cephalometric measurements with temporomandibular disorders in a sample of adult Egyptian subjects in. The main questions it aims to answer are:

* Is there a correlation between missing posterior teeth and temporomandibular disorders?
* Is there a correlation between vertical dimension cephalometric measurements and temporomandibular disorders? Participants will be asked for the following:-

  * to give their phone numbers \& it will be collected through the orthodontic department patient's database ensuring complete confidentiality.
  * to fill Personal data chart (name, age, date of birth, mobile number, address).
  * to receive Clinical examination to determine number of missing teeth.
  * to receive Clinical examination to diagnose TMD using the DC/TMD.
  * to do Lateral cephalometric radiograph to measure the vertical dimension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with 2 or more missing posterior teeth seeking treatment at the faculty.
* Age: 16-49 years.

Exclusion Criteria:

* - Patients who refuse to participate in the study.
* Patients younger than 16 years.
* Subjects who received previous TMD treatment.
* Subjects suffering from systemic conditions which may affect the functioning of TMJ, for example, rheumatoid arthritis, scleroderma, and septic arthritis.
* Subjects with a history of trauma to the maxillofacial area.
* Subjects with a previous history of maxillofacial surgery.
* Subjects with a history of malignancy or current malignancy of the maxillofacial area.
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Objective Primary:

Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen

Secondary:

Determine time to progression-free survival and overall survival of patients treated with this regimen.

Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen

Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study

Chemotherapy regimen:

Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total

Patients: A total of 260 patients (130 per group) will be accrued for this study.

Patients distribution:

10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial.

Clinical Outcome Assessments:

Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event

Safety Assessments:

Physical exam, laboratory test, probably occurred adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable locally advanced disease or unresectable local recurrence, including:

   * Patients with unresectable advanced gallbladder cancer （≥ Nevin staging IV or TNM（ tumor node metastasis） classification）
   * Patients with complication who have no indication for surgery
   * Patients with unresectable local recurrence lesions
2. Age between 18-75, no gender-based constraints
3. Estimated life expectancy ≥12 weeks
4. KPS（Karnofsky performance status ）≥60
5. Each patient gave written informed consent
6. \< 2 previous chemotherapy regimes
7. No chemotherapy done in the last 4 weeks
8. Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count \> 3,000/mm3 ;Platelet \>100,000/mm3 Total bilirubin \<5.0mg/dl ALT（alanine transaminase）、 AST（aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN（blood urea nitrogen）≤ 2 times upper limit of normal; serum creatinine \<1.5mg/dl: creatinine clearance rate \< 60 ml/min
9. Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
10. Jaundice should be reduced to standard level before chemotherapy (Total bilirubin \<5.0 mg/dl)

Exclusion Criteria:

1. Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
2. Patients who are pregnant or breastfeeding.
3. Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
4. Patients who had a history of previous carcinoma in the last 5 years.
5. Patients who are allergic to somatostatin or fluorouracil
6. Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.