cyrilzakka/clinical-trials huggingface dataset:
Text Messaging to Improve HIV Testing Among Young Women in Kenya

The purpose of this study is to determine whether regularly scheduled HIV sensitization text messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.

In Kenya, women have higher rates of infection (6.9%) than men (4.4%) and young women aged 15-24 years are over three times more likely to be infected than young men of the same age group. HIV testing and counseling remains critical to identifying new infections and preventing the spread of HIV but many young women do not test and still continue to engage in high risk behavior.

HIV programs have begun to leverage mobile phones and text messages to increase the reach and scale of interventions. Kenya currently has 32.2 million mobile phone subscribers, representing a 79.2% country penetration. Text messages have been used successfully in Kenya for marketing purposes and have even been demonstrated to increase antiretroviral (ART) adherence. Despite advances in mobile-based applications to improve issues in health, none of these health applications have yet been able to reach the scale of mobile phone-based financial products in Kenya.

Given the potential synergies of text message use and need for HIV testing, a randomized quasi-experimental study was conducted to test whether weekly text messages encouraging HIV testing and improving HIV awareness would increase HIV testing, enhance HIV risk perception and reduce high risk behaviour among young women 18-24 years old in a predominantly rural region in Kenya.

Women in the intervention arm received access to a suite of HIV sensitization text messages sent weekly to increase their awareness of HIV and encourage them to test with the option of texting back for more information to a maximum of three times per week. Women in the control arm did not receive these messages. All women were followed up for six months with monthly SMS surveys collecting data on their HIV testing practices, sexual behaviour and risk perception.

Eligibility Criteria:
Inclusion Criteria:

* Own a mobile phone which they don't share and which operates on a telecom provider supported by our SMS platform
* Be HIV uninfected (by self report) or not know their HIV status
* Report not having tested for HIV in the preceding 12 months
* Know how to send and receive SMS
* Must consent to the study
* Have regular access to electricity for charging a cell phone

Exclusion Criteria:

* Did not consent to the study
* Did not meet inclusion criteria
Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.

Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.

Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.

Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.

Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.

Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.

Cost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.

Interim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.

Eligibility Criteria:
Inclusion Criteria:

* Male \<60yrs with primary inguinal hernia

Exclusion Criteria:

* Recurrent hernia
* Bilateral hernia
* Non-reducible/obstructed hernia
* Previous lower abdominal surgery/radiotherapy
Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects

The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.

Objectives:

1. The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.
2. The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, without respiratory or cardiac comorbidities
* Age 18-55 years, inclusive
* FEV1 \> 80% predicted and FEV1/FVC ratio \>70%
* Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation
* Subjects who are capable of providing their written informed consent to participate in the study

Exclusion Criteria:

* History of smoking \> 10 pack-years
* Any history of smoking within 60 days of screening
* Acute upper or lower respiratory illness within 30 days of screening
* Respiratory medication for any indication within 30 days of screening
* History of asthma, chronic bronchitis, or other chronic lung disease
* History of intolerance to hypertonic saline
* Women who are pregnant, lactating, or of childbearing potential who are unwilling to use an acceptable method of contraception throughout the duration of the study.
* Any condition that, in the opinion of the investigator, would potentially jeopardize the safety of the participant or the integrity of the study
* History of radiation exposure within the past year that would cause the subject to exceed limits for adults established by Federal Regulations
* Subjects who, in the opinion of the Principal Investigator, should not participate in the study
Effects of Post-COVID-19 on Quadriceps Femoral Muscle-tendon Unit

The physiological/biomechanical characteristics related to muscle and tendon architecture and their possible relationship with the loss of muscle strength and fatigue in patients who were infected with COVID-19 are totally unknown. The aim of this study is to evaluate inflammatory markers, the isometric maximum voluntary force of the knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, tendinous properties of quadriceps components, oxygen extraction, and body composition in participants after diagnosis with Covid-19 who had moderate and severe levels of involvement compared to a healthy control group.

The groups will be composed of participants who had COVID-19, except for the control group, which will be composed of healthy participants who did not have COVID-19. Participants will be divided into: (1) control group, (2) COVID-19 positive participants who had moderate symptoms, (3) COVID-19 positive participants who had severe symptoms. Participants will be recruited from 21 days after the onset of symptoms, the period recommended by the scientific community that the patient no longer transmits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). After recruitment, 4 evaluations will be carried out over 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Control group:

  - The control group will include healthy participants, aged 18 and 80 years, who had not tested positive for COVID-19.
* COVID-19 positive participants who had moderate symptoms group:

  * Female and male participants, aged between 18 and 80 years, who had Molecular test (RT-PCR) or serological test, which assesses whether the samples are reactive to immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies, positive for COVID-19;
  * Presence of some of the following symptoms, without the need for hospitalization: dry cough, runny nose, sore throat, diffuse body pain, persistent hyperthermia, no hypoxemia.
* COVID-19 positive participants who had severe symptoms group:

  * Female and male participants, aged between 18 and 80 years, who had Molecular test (RT-PCR) or serological test (which assesses whether the samples are reactive to IgM and IgG antibodies) positive for COVID-19;
  * Presence of hypoxemia (peripheral oxygen saturation - SPO2 ≤ 93%) requiring hospitalization with or without intubation, in addition to the symptoms described for the COVID-19 positive participants who had moderate symptoms group.

Exclusion Criteria:

* Body Mass Index (BMI) ≥ 35 kg/m2;
* Pregnancy;
* Pain, swelling, dermal damage, deformity, or amputation in the regions to be examined;
* Diagnosis of ankylosing spondylitis, rheumatoid arthritis, severe heart disease, advanced chronic obstructive pulmonary disease, cognitive impairment, chemical dependency, psychiatric illness, or behavioral that makes it difficult to cooperate with the procedures.
Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)

This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).

The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

ESME LC Data Platform aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating sites.

Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.

Eligibility Criteria:
Inclusion criteria :

* Adult (over 18)
* Treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site

Exclusion criteria

- None
A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum

This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.


Eligibility Criteria:
Inclusion Criteria:

* Willing subjects in good general health.

  * Males aged 18 to 60; females aged 50 to 60.
  * Subjects who planned to stay in the study area until the end of the study.

Exclusion Criteria:

* Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.

  * Subjects with a personal or family history of seizures or frank psychiatric disorder.
  * Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
  * Females who were lactating.
  * Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
  * Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
  * Subjects with known hypersensitivity to any of the study drugs.
  * Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
  * Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
  * Subjects with any of the following laboratory values: haemoglobin (Hb) \<8g/dL, platelets \<80,000/mm3, white blood cell count (WBC) \<3000/mm3, creatinine \>1.5mg/dL, alanine transaminase (ALT) \>60IU or 1+ haematuria as detected by urine dipstick.
Evaluation of Spa Therapy in the Treatment of Fibromyalgia

Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.

Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) \> 39 will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* both sexes, more than 18 years old patients
* available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months
* with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months
* with a FIQ score \> or = 39 (fibromyalgia moderate to severe)
* voluntary to participate to the study, informed consent form signed after appropriate information
* affiliation to the social security system or equivalent

Exclusion Criteria:

* contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
* no previous spa treatment in rheumatology within 1 year prior to inclusion
* substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)
* subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)
* subject participating to an other clinical study inerventionnal
* pregnancy, parturient or breast feeding
* no psychiatric illness or social situation that would preclude study compliance
Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy

The purpose of this study is to determine whether IGF-1 therapy improves or preserves muscle function in Duchenne Muscular Dystrophy (DMD).

Detailed Description:

DMD is a progressive degenerative muscle disorder for which there is no current cure. Glucocorticoids (GC) are often used to improve motor function and survival but have significant side effects such as growth failure, weight gain, insulin resistance and osteoporosis. IGF-1 stimulates both the proliferation and differentiation of skeletal muscle cells and is thus important for muscle repair and regeneration. IGF-1 offers potential as a therapeutic agent for DMD as it may improve or preserve motor function and reduce GC side effects such as growth failure and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* DMD diagnosed with mutational testing and/or complete absence of dystrophin on muscle biopsy
* Proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor and going up steps)
* Male
* Age \> 5 years of age
* Bone maturation (assess by bone age x-ray): \</= 11 years of age
* Daily GC (prednisone or deflazacort) therapy for \> 12 months
* Ambulatory
* Informed consent
* Willingness and ability to comply with all protocol requirements and procedures

Exclusion Criteria:

* Current or prior treatment with growth hormone or IGF-1 therapy
* Non-ambulatory
* Pubertal (based on clinical Tanner staging examination)
* Congestive cardiac failure
* History of intracranial hypertension
* Daytime ventilatory dependence (non-invasive or tracheostomy)
* Concomitant therapy - any other medications/supplements that would be considered, in the opinion of the investigators, to affect muscle function, need to have been started 3 months prior to enrollment
* Patients enrolled in other clinical drug trials
* Any physical or mental conditions which may, in the investigators'opinions, render the subject unable to complete the tasks of the study appropriately
* There will be no selection by ethnicity
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.

This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS conducted in multiple centers. Drug or placebo will be given intravenously. Approximately 105 subjects will be enrolled. Subjects will be allocated (1:1:1) to placebo and 2 dose levels of NP001.

Eligibility Criteria:
Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. A list of key criteria is listed below:

Inclusion Criteria:

* Onset of symptoms less than 3 years prior to study entry.
* Forced Vital Capacity (FVC) at least 70% of that predicted for age and height.
* Stable dose of riluzole if undergoing treatment with this agent.
* For females: Not be of childbearing potential or agree to use adequate birth control during the study.

Exclusion Criteria:

* Unstable medical condition(s) other than ALS.
* Life expectancy of less than 6 months.
* Require life-sustaining interventions for the 6 months following randomization.
* Have a tracheotomy or be using ventilatory assistance \[including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)\].
* Active pulmonary disease.
* Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.
DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness

Chronic pain is defined as an unpleasant sensory and emotional experience that persists for three months or more, affecting 20-30% of the global adult population. It can arise from primary conditions or as a consequence of diseases and is a significant source of disability. Chronic pain is no longer merely a symptom but often a disease itself, with neurological and psychosocial mechanisms. The biopsychosocial model introduced by George Engel in 1977 helps to consider the biological, psychological, social, and societal dimensions of chronic pain. Patients with chronic pain must adapt to new circumstances, acquiring new knowledge and coping skills to reach a new homeostasis. The goal is not necessarily pain elimination but enabling patients to manage their pain and continue daily activities effectively.

International guidelines suggest a patient-centered, interdisciplinary approach to managing chronic pain, with an emphasis on empowering patients, motivating them, and involving them in decision-making. Autonomy in decision-making is crucial in this context, encompassing both negative freedom (absence of external constraints) and positive freedom (the ability to make choices and realize one's potential). However, chronic pain can limit cognitive and functional abilities, potentially impeding a patient's autonomy. Research indicates that a significant proportion of chronic pain patients experience a deficit in decision-making autonomy.

This mixed-methods study aims to explore the determinants of decision-making autonomy in chronic pain patients and its impact on their treatment. Using the MacCAT-T assessment tool, which evaluates understanding, reasoning, appreciation, and choice expression, the study will examine the relationship between patients' autonomy levels and their health outcomes. The study will also assess how clinicians perceive patients' autonomy compared to the tool's findings.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older Patient attending their first consultation for chronic pain between 01/01/2025 and 31/12/2025 Francophone patient Patient capable of expressing their non-opposition to participation

Exclusion Criteria:

* Patient with significant visual or hearing impairment Patient under guardianship or curatorship Patient deprived of liberty Patient under judicial protection Patient who opposes the use of their data for this research
Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

Open label, single dose and phase I study.

The primary objective: To determine the maximum tolerated dose in Single dose

The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.

1. Number of Subjects: 28\~36, dose escalation (2\~6 subject of each step)
2. Adverse Events will be coded to preferred therm and body system using the CTCAE

Eligibility Criteria:
Inclusion Criteria:

* from 20 years old to 69 years old
* diagnosed with progressive solid cancer
* In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected.
* Evaluated 0-1 of ECOG
* Expected life duration is within 3 months

Exclusion Criteria:

* Major surgery except tumor-removal surgery received within 2 weeks of screening.
* history of CNS metasis
* hyper-sensitivy of study drug
* pregancy or lactating
* administered other HDAC inhibitor within 4 weeks of screening