cyrilzakka/clinical-trials huggingface dataset:
Study of Samalizumab in Patients With Advanced Cancer

This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV) samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability, pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced cancer. The study was terminated for administrative reasons and not due to any safety concerns.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participant was ≥ 18 years of age at Screening.
2. Eastern Cooperative Oncology Group performance status of 0 to 2.
3. Participant had advanced/metastatic cancer with disease progression after treatment with all available therapies known to confer clinical benefit.
4. Participant had a life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Participant had a symptomatic brain metastasis.
2. Participant had active gastrointestinal bleeding as evidenced by either hematemesis or melena.
3. Participant had acute gastrointestinal ulcers.
4. Participant had a history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
5. Participant with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
6. Participant had an active infection requiring therapy.
7. Participant's serum was positive for the presence of hepatitis B surface antigen, antibodies to hepatitis C virus, or antibodies to human immunodeficiency virus 1/2.
8. Participant had significant cardiovascular impairment (history of New York Heart Association Functional Classification system Class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to study drug treatment.
9. The participant's most recent test values within 14 days before the date of entry met the following standards:

   * Bone marrow function: neutrophil count ≤1500/millimeter (mm)\^3, hemoglobin ≤9.0 grams/deciliter, platelet count ≤100,000/mm\^3.
   * Liver function: total bilirubin ≥1.5 x the upper limit of normal (ULN) based on the standard value of each institution, aspartate aminotransferase and alanine aminotransferase ≥2.5 x ULN based on the reference laboratory.
   * Renal function: serum creatinine ≥1.5 x ULN based on the reference laboratory.
10. Participant had ongoing immune-stimulated adverse events from other immunotherapies (for example, pneumonitis, thyroiditis, or hepatitis) or a history of pneumonitis.
11. Participant had received chemotherapy, targeted therapy, and/or immunotherapy within the 28 days prior to first dose of study drug, or within a Washout Period for the chemotherapy, targeted therapy, and/or immunotherapy of 5 half-lives, whichever occurred first.
12. Participant had toxicities from previous immunotherapy that had not resolved to Grade 1.
The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF

Interventional studies compared electroacupuncture group versus sham electroacupuncture group to granulosa cell apoptosis index, oocyte maturation, GDF9 and BMP15 levels, and fertilization rate in in vitro fertilization program

The study was conducted at the Dr.Cipto Mangunkusumo National General Hospital, Indonesia in September - November 2018.The inclusion criteria are patients who underwent controlled ovarian stimulation with antagonist protocol, age 30-39 years, BMI \<29kg / m2. Exclusion criteria were not having a skin infection at acupuncture point and not using a pacemaker. Then patients were randomly divided into two groups: electroacupuncture and sham electroacupuncture. Electroacupuncture therapy was done 6 times at: 2 times before and 4 times during controlled ovarian stimulation.Apoptotic index of granulosa cells were examined by quantitative real time PCR techniques for BAX/BCL-2 expression.Oocyte maturation and fertilization rate output parameters are examined by competent embryologists after ovum pick up while GDF9 and BMP15 levels were examined by quantitative real time PCR techniques for GDF9 and BMP15 mRNA expression

Eligibility Criteria:
Inclusion Criteria:

* women underwent controlled ovarian stimulation with antagonist protocol
* BMI \< 29 kg/m2
* willing and sign the inform consent
* follow the research until completed

Exclusion Criteria:

* having skin infection at acupoint location
* use a pacemaker
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure

\* Secondary Endpoints:

* Feasibility of early transplantation within a multicenter trial
* Leukemia-free survival (LFS) at 2 years from transplantation
* Leukemia Response rate at day +30, +90 and 6 months
* Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)
* Incidence and severity of acute and chronic Graft-versus-Host disease
* Feasibility and safety of early discontinuation of immunosuppressive therapy

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease)
* Age: 18-55 years
* Availability of an HLA identical family donor OR unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
* Have adequate renal and hepatic functions as indicated by the following laboratory values:
* Serum creatinine ≤1.0 mg/dL; if serum creatinine \>1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \>60 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female)
* Serum bilirubin ≤1.5 mg/dL × upper limit of normal (ULN)
* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN
* Alkaline phosphatase ≤2.5 × ULN

Exclusion Criteria:

* Documented chloroma
* Patients having AML M3
* Documented leukemic infiltration of CNS/cerebrospinal fluid
* Karnofsky performance score below \< 60%
* Acute or chronic heart failure
* HIV infection, chronic viral hepatitis
* Severe neurological or psychiatric disorders
* Any circumstances that preclude the use of the drugs used within the protocol
* Prior allogeneic or autologous stem cell transplantation
* \> 3 courses of prior chemotherapy
* Denied informed consent
* Pregnancy or denied of effective contraceptive method
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

This study \[contRAst 1 (201790: NCT03980483)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.


Eligibility Criteria:
Key inclusion criteria

* \>=18 years of age
* Has had RA for \>=6 months and was not diagnosed before 16 years of age
* Has active disease, as defined by having both:\*

  * \>=6/68 tender/painful joint count (TJC), and
  * \>=6/66 swollen joint count (SJC)
* Has at least 1 bone erosion present on hand/wrist or foot radiographs
* Has had an inadequate response to MTX, despite currently taking MTX 15-25 mg/week\*\* oral or injected

  * If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

    * A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

Key exclusion criteria

* Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
* Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved)
* Has received prior treatment with a biologic Disease-modifying antirheumatic drug (DMARD) which has been discontinued due to an inadequate response.
Variation in Rate of Orthodontic Tooth Movement in Response to Platelet Rich Plasma Therapy

PRP from 5 ml blood was prepared and 60 units were injected into the buccal vestibule of patient before initiating canine retraction using NiTi coil spring. Pre and post cervical, incisal and mid distances were measured using Vernier calliper.

Platelet rich plasma was prepared using patients own blood. The production of PRP began with a 6-mL homologous blood sample that was withdrawn from the donor via venupuncture. One milliliter of the blood sample was set apart to determine the concentration of platelets and leukocytes in whole blood. The remaining 5 mL was mixed with an anticoagulant (3.8%, 1-mL sodium citrate) to prevent clotting. The blood sample was centrifuged at 113 g for 5 minutes to separate the plasma containing the platelets from the red cells. The plasma was drawn off the top and centrifuged for an additional 2 minutes at 3772 g to separate the platelets. Suitable platelet concentrations were achieved by the resuspension of PRP with plasma (high platelet concentration, 5 times the concentration in whole blood).

Eligibility Criteria:
Inclusion Criteria:

* patients requiring first premolar extractions

Exclusion Criteria:

* patients taking any drugs, steroids, NSAIDs and antibiotics
* patients with any co morbid conditions
Mechanism of Action of Vichy Catalan Water

Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated mineral waters are reported to have beneficial digestive and hypocholesterolemic properties. The aim of this study was to investigate the effects of the consumption of a sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral content water as a control water (CW), on postprandial serum triacylglycerols (TAG), cholecystokinin (CCK), and gallbladder volume.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 and \<40 years)
* BMI \>18 and \<30 kg/m2

Exclusion Criteria:

* Age \<18 and \> 40 years
* TAG \> 250 mg/dL (2.82 mmol/L)
* Being a usual consumer of carbonic mineral water
* Obesity
* Diabetes
* Hypertension or digestive, liver and renal disease
* Biliary obstruction
* Eating disorders
* Being under medication that could affect lipid metabolism
* Consumption of functional foods that could affect lipid metabolism (food containing n-3 fatty acids or phytosterols)
The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer

Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.

Biliary cancer ranked fifth in all gastrointestinal malignant cancer. Epidemiological surveys showed a significant increasing trend in recent years. How can make an early diagnosis of bile duct cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

cf-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the cf-DNA originates from tumoral tissue. This, and the fact that cf-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer. And we call the cf-DNA of tumor as ct-DNA.

Peripheral blood mononuclear cells (PBMC) is any peripheral blood cell having a round nucleus. These cells can be extracted from whole blood using ficoll, a hydrophilic polysaccharide. PBMC contains genetic material of tumor and may be applied as a biomarker.

This study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected biliary tract cancer
* Age from 18 - 70 years
* No serious organic and mental illness;

Exclusion Criteria:

* Pregnancy
* No pathologic result
* Suffering other malignancies at the same time.
Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel

Statement of the problem: Immediate implant placement is faced with several problems. One of the most important is the jumping gap present after implant placement and whether it needs to be augmented or not.

Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.

Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region requiring implant placement. They will be randomly allocated to two equal groups. Group A (control group, n=12) will receive immediate implants (grafting with xenograft), and group B (test group, n=12) will receive immediate implants (grafting with xenograft\& HAM). After implant placement, buccal bone thickness (1ry outcome), bone density (2nd outcome) and implant stability will be assessed (2nd outcome). The parameters will be assessed at baseline, 6 and 12 months. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old, with non-restorable first and second molars indicated for immediate implant placement in both arches.
* Patient who are medically free patients (American Society of Anesthesiologists I; ASA I)
* Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
* Minimum alveolar Bucco-palatal dimension of 7 mm.

Exclusion Criteria:

* Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
* Patients who are smokers.
* Presence of signs of active infection or pus formation.
* Absence or loss of buccal wall prior to implant placement.
Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease

12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[STNmono\] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata \[STN+SNr\].

A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts \[STN+SNr\] in refractory hypokinetic gait disturbances compared with \[STNmono\] (active comparator). The results will clarify, whether the combined \[STN+SNr\] stimulation improves otherwise refractory gait disturbances in PD.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age: between 18 and 80 years
* Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
* Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
* Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical \[MedOn/STNmono\] condition ≥ 12
* Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
* Dopaminergic medication constant for at least four weeks prior to study enrolment
* Disease duration ≥ 5 years

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Exam \< 25)
* Participation in other clinical trials within the past three months and during enrolment in our study
* Suicidality, Psychosis
* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
* Pregnancy
* Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol
Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

Rationale for conducting the experiment: Israel performed IVF treatments since 1980.

Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and pregnancy rates have not met the expectations yet. Success rates of fertility treatments are about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical, technological and complimentary) have been tried to improve the CPR.

In some reviews the effects of acupuncture practice during fertility treatments showed certain benefits, including pain relief and relaxation. Unfortunately those trials were not randomized and lacked methodological rigor.

The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of women undergoing IVF as compared to standard care alone.

Women planned for IVF at the investigators' institution will be offered to participate in this trial. Following consent, women will be randomized to acupuncture in addition to standard care OR standard care only according to the working days of the acupuncture practitioner (working alternately three days a week).

After IVF stimulation protocol the patients in the acupuncture group will have three acupuncture treatments: The first will take place right after oocytes retrieval and the second treatment will be right before embryo transfer, and lastly 20-30 minutes after embryo transfer. Patients in the control group will receive standard care only. Patients in both groups will fill out questionnaires regarding expectations from complementary medicine (likert scale no expectation--high expectation), anxiety level (Visual Analogue Scale= VAS) before the procedures, as well as pain assessment (VAS) before and after the IVF procedures. In addition, a general satisfaction questionnaire from the overall care at the IVF unit will be completed at the last visit (likert scale very unsatisfied--highly satisfied). Finally, the physicians will report procedure ease or complexity on a likert scale (very easy-very difficult).

Eligibility Criteria:
Inclusion Criteria:

* Any patient who under going an IVF treatment in the investigators' unit.

Exclusion Criteria:

* Patient who disagree to participate in the study,
* Patient who are undergoing ovulation induction or AID.
Personalized Digital Remote Monitoring for Elderly Patients

Objective This clinical investigation aims to evaluate whether the EPOCA Remote Monitoring System (RMS) enhances care for elderly patients with multiple chronic conditions and reduces unplanned hospitalizations.

Key Research Questions

This study will assess:

* Unplanned Hospitalizations: Does EPOCA RMS reduce the total number of unplanned hospital days over 12 months?
* Quality of Life \& Costs: What is the impact of EPOCA RMS on patients' quality of life and overall healthcare costs?
* Survival Rates: Does EPOCA RMS improve survival rates compared to standard care?

Participant Criteria

Participants must:

* Be 75 years or older with at least three chronic conditions.
* Have experienced a hospitalization or fall in the past year.
* Be randomly assigned to either the EPOCA RMS group or a control group receiving standard care.
* Be monitored for 12 months, with data collected at multiple time points.

Study Design

* Type: Multicenter, randomized controlled trial (RCT).
* Sites: Conducted across 8 hospitals in France.
* Duration: 12-month follow-up.
* Sample Size: 700 participants (350 per group).
* Intervention Group: Remote monitoring through the EPOCA RMS, integrating connected devices and medical coordination.
* Control Group: Standard care follow-up.

Expected Outcomes

* Reduced unplanned hospital stays and emergency visits.
* Improved quality of life and patient satisfaction.
* Comprehensive cost-effectiveness analysis and economic impact assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years,
* Three or more chronic pathologies (e.g., diabetes, heart disease, depression, cancer, respiratory failure, renal failure, dementia),
* Hospitalization or fall at least once in the previous year (Y-1),
* Recently discharged from the emergency department (within 24 hours),
* Patients, with or without caregivers, who accepted to participate and provided informed consent.

Exclusion Criteria:

* Patients discharged to or having been institutionalized in nursing homes (EHPAD),
* Patients enrolled in another clinical trial
* Suicidal or hetero-aggressive risk in a patient alone at home,
* Homeless patients,
* Patients protected by the following French legal measure: "sauvegarde de justice"