cyrilzakka/clinical-trials huggingface dataset:
Examining the Real-World Effectiveness of the Movr App

The objective of this 8-week pilot pragmatic randomized controlled trial was to examine the real-world impact of movr on functional movement, flexibility, strength, and cardiovascular fitness.

Thousands of mobile apps available for download are geared towards health and fitness, yet limited research has evaluated the real-world effectiveness of such apps. The movr app is an mHealth app designed to enhance physical functioning by prescribing functional movement training based on individualized movement assessments. movr's influence on functional movement and physical fitness (flexibility, strength, and cardiovascular fitness) has not yet been established empirically. Thus, the objective of this 8-week pilot pragmatic randomized controlled trial was to examine the real-world impact of movr on functional movement, flexibility, strength, and cardiovascular fitness.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 50 years
* Ability to read and write English
* Owned a mobile device that could download applications from the App Store or Google Play

Exclusion Criteria:

* Previously used the movr app
* Had any contraindications to exercise based on the Get Active Questionnaire
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

The research aims to answer the question: "Does the addition of a Glucose-dependent Insulinotropic Polypeptide (GIP)/Glucagon-like Peptide-1 (GLP-1) co-agonist to standard progestin treatment lead to a higher complete response rate compared to historical response rates using progestin alone in young patients with endometrial cancer/atypical hyperplasia who wish to preserve their fertility?".

This is a multicentre single arm open-label phase II clinical trial to assess the complete pathologic response as determined by endometrial sampling after 48 weeks of tirzepatide (GIP/GLP-1 co-agonist) and progestin therapy in patients with BMI ≥ 27 who have endometrial cancer/atypical hyperplasia and desire fertility preservation.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27
* Diagnosis of grade 1 or 2 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage
* For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT
* ECOG status \<2
* Desire for fertility preservation
* Ability to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Evidence of myometrial invasion or extra-uterine disease on imaging
* High grade or p53 mutated (p53mut) endometrial cancer
* Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining\>10%)
* Mismatch repair deficient (MMRd) endometrial cancer
* History of other malignancies except if curatively treated with no evidence of disease for \>5 years
* Previous surgical treatment of obesity
* Current use of weight loss medication (no use in last 2 months)
* Medical co-morbidity with end-organ dysfunction
* Contraindications to pIUD or tirzepatide.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate.
* Subject is scheduled for RP as the initial therapy for localized prostate cancer.
* Subject is ≥ 18 years of age.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has adequate hematologic, renal, and liver function.

Exclusion Criteria:

* Subject has any evidence of metastasis.
* Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
* Subject has received prior radiation therapy or chemotherapy for prostate cancer.
* Subject has received systemic steroid therapy within 14 days.
* Subject has a history of stage III or greater cancer, excluding prostate cancer.
* Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
* Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
Supporting Family Carers' Mental Health

Brief Summary:

Background: Feasibility and acceptability of the Carers-ID intervention to improve mental health outcomes in family carers of people with intellectual disabilities.

Objective:

1. To conduct a Phase II feasibility randomised controlled trial and process evaluation of the Carers-ID programme.
2. To determine the acceptability of outcome measures of stress, anxiety, depression, resilience and well-being in assessing the impact of the programme on family carers.
3. To determine the recruitment and retention rates of participants in the trial.
4. To identify potential effect sizes and estimate appropriate sample size for use in an effectiveness trial.
5. To determine if progression to a phase III effectiveness trial is warranted.

Methodology:

Family carers (n = 120) will be randomised to receive the programme (n=60) or assigned to a wait-list control (n=60) group. The intervention (Carers-ID) consists of ten modules which cover topics including: promoting resilience, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in the process evaluation.

Outcome:

1. Retention of Subjects in Study Assessments (\>80% of family carers)
2. Recruitment of Subjects into Study (\>90 carers)
3. Acceptability and feasibility of the outcome measures (\>80% of family carers)
4. Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised.

Number of participants to be enrolled: 120 family carers

Main inclusion criteria: Participants will be UK adults \>18 years of age and will be caring for a family member with an intellectual disability.

Statistical Analysis: Descriptive statistics will be used to summarise baseline data including demographic variables and questionnaire responses. Inferential statistics (t-tests or ANOVA) will be used as indicators of difference between the intervention and control arms and will be used to determine effect sizes for sample size calculation in a future phase III trial.

Study duration: 24 months


Eligibility Criteria:
Inclusion Criteria:

* Resident of the UK;
* \>18 years of age;
* Caring for a family member with an intellectual disability.
A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients
* aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
* have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
* all females must test negative for pregnancy at the time of enrollment
* have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria:

* have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
* have regional pain syndrome, multiple surgeries or failed back syndrome
* have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of CTCL; a documented verifiable biopsy report is required
* Documented clinical stage IA, IB or IIA CTCL
* Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
* ECOG performance status of 0-2

Exclusion Criteria:

* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
* Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
* Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
* Any prior history of hematologic malignancy (other than CTCL) within past 5 years
* CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
* Prior or concurrent central nervous system (CNS) metastases
* History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
* Evidence of active Hepatitis B or C or HIV
* Circulating atypical cells of clinical significance
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus
Usability of the Smart Hallway System in Clinical Setting

The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

The goal of the study is to use off-the-shelves markerless and contactless technologies and automatically digitise the person's movements as they walk through an institutional hallway. Multi-camera-based technologies can merge 2D-video into 3D-information. With an appropriate software, one can acquire data, perform the kinematic calculations and generate a report, all with minimal or no human intervention. The specific research question are whether pathological gait or walking disorders of the patients can be identified and classified based on the system's output, whether signs of depression can be classified from the the system's output, and whether the results of the 6-minute walk test can be predicted from the the system's output.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk at least 10 metres without help of a person,
* no severe cognitive problems (able to answer questionnaires),
* native Slovenian speakers,
* wiling to participate (signed informed consent)

Exclusion Criteria:

* severe cognitive impairment,
* not being able to walk with or without a prosthesis or orthosis.
Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.

II. objectives

at. primary objective

Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.

Evaluation criteria (absence of EG)?

b. secondary objectives

i. Evaluation of the acceptance rates of ambulatory care patients eligible

ii. Evaluation of the rate and type of complication in our series

iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)

IV. Methodology and duration of the research

This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.

The inclusion of patients will take place over a period of 4 months.

The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.

After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.

Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.

Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.

The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized.

Eligibility Criteria:
Inclusion Criteria:

* Isolated ACL tear
* First arthroscopic reconstruction at DIDT

Exclusion Criteria:

* Age over 60 years
* ASA score greater than 2
* Geographical remoteness
* Social isolation
* medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
* psychiatric pathology
Study of Pain Control in Diagnostic Hysteroscopy

The goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. The main question it aims to answer is "Do the Paracetamol and Ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

After the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get Paracetamol 500mg and Ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in VAS before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

Eligibility Criteria:
Inclusion Criteria:

* Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old

Exclusion Criteria:

* Women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding
* Women with history of allergy to Paracetamol or Ibuprofen medicine
* Women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding
* Women with currently taking anticoagulant or antiplatelet medications
* Women with history of psychiatric disorders
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Eligibility Criteria:
Inclusion Criteria:

* Age: at least 20 years of age
* Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
* Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
* At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
* World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
* Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
* At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
* Adequate hematological and biological function
* Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
* Male patients should be documented to be sterile or agree to use barrier contraception
* Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia

Exclusion Criteria:

* Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
* Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
* Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
* Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
* History of any other malignancy
* Clinically significant uncontrolled condition(s)
* Active or chronic pancreatitis
* Anyone with cardiac abnormalities or history
* Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
* Pregnant or breast feeding
* In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.