cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \< 5 years in 3 sites in rural Tanzania.

Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \< 5 years in 3 sites in rural Tanzania.

Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Eligibility Criteria:
Inclusion Criteria:

Children \< 5 years of age (in one site, patients of all ages are eligible).

Documented fever (axillary temperature \>= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition

Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3

Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study

Exclusion Criteria:

Any evidence of severe malaria that would require hospitalization for treatment.

Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.

History of pregnancy or delayed menstrual period

Breastfeeding a child less than 8 weeks of age
Study of AT-752 in Healthy Subjects

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) of 18-29 kg/m2
2. Must agree to use protocol-specified methods of contraception
3. Negative pregnancy test
4. Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Abuse of alcohol or drugs
3. Use of other investigational drugs within 30 days of dosing
4. Other clinically significant medical conditions
Nicotine Replacement for Smoking Cessation During Pregnancy

This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.

Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.

Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants

Eligibility Criteria:
Inclusion Criteria:

* smoking at least 5 cigarettes per day for the preceding 7 days
* previous attempt to quit smoking during pregnancy by self report
* 13-26 weeks gestation
* at least 16 years of age
* able to speak English or Spanish
* intent to carry pregnancy to term
* stable residence

Exclusion Criteria:

* current drug or alcohol abuse or dependence (other than methadone maintenance)
* twins or other multiple gestation
* unstable psychiatric disorder
* unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
* known congenital abnormality
A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

The study is to investigate the effect of a soft robotic glove approach providing continuous passive motion of fingers (flexion and extension) on degenerative arthritis patients. The approach may help reduce pain, maintain mobility and flexibility and to improve hand function.

The aim is to investigate the effect of soft robotic gloves in providing continuous passive motion of the fingers (finger flexion and extension) of degenerative arthritis patients, for the purpose of providing pain relief and alleviating stiffness at the finger joints. Specifically, we intend to 1) observe the changes in range of motion of the fingers using the Total Active Motion (TAM) measure; 2) observe the changes in grip strength and pinch strength; and 3) record changes in the patients' perception of performance in activities of daily living using the Canadian Occupational Performance Measure (COPM).

The hypothesis is that a soft robotics approach in providing continuous passive motion of the finger joints of degenerative arthritis patients can reduce pain, maintain mobility and flexibility of the joints, and to improve hand function. The soft robotics approach and the standard hand therapy is better than the standard hand therapy alone.

The proposed soft robotic glove is capable of providing continuous passive motion (flexion and extension) of the fingers, and in addition, it is also designed to be portable and easy to operate, with minimal supervision. It is aimed at the home therapy of degenerative arthritis patients. In this study, by using the soft robotic glove and in observing changes in finger range of motion, grip and pinch strength, as well as perception of performance in daily activities. This is important in establishing this device as a viable means to ultimately slow down the progression of degenerative arthritis, and to significantly improve the patients' abilities in carrying out activities of daily living, which had been impaired by degenerative arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 30-90 years regardless of race
2. Osteoarthritis of the hand (Consistent with ACR criteria 1990)
3. Ability to pay attention and maintain supported sitting for 45 mins continuously
4. Able to give own consent
5. Able to comprehend and follow commands (Abbreviated Mental Test \>= 7)

Exclusion Criteria:

1. Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
2. Recent steroid injections in the wrist/hand joints within the past 3 months
3. Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
4. Old stroke and/or spasticity affecting the upper limbs
5. Epilepsy for the last 6 months as of the date of recruitment
6. Poor skin conditions which would hamper donning robotic gloves
7. Pregnancy
Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)

A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)

In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group.

The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization).
* Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
* A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
* Participants must receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week.
* Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff

Exclusion Criteria:

* A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG)
* Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled
* History of balance disorder including vertigo, motion sensitivity, or balance disorder
* Primary sensory impairment (blindness, deafness)
* Motor disorder that would interfere with VR engagement
Treatment Shortening of MDR-TB Using Existing and New Drugs

The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24 months (control arm)' for treating fluoroquinolone-sensitive multidrug-resistant tuberculosis.

This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20-24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after treatment initiation. Secondary outcomes include time to sputum culture conversion on liquid and solid media, proportions of sputum culture conversion on liquid media after 2 and 6 months of treatment, treatment success rate according to pyrazinamide resistance, and occurrence of adverse events grade 3 and above as evaluated by the Common Terminology Criteria for Adverse Events. The population number is calculated as 102 per group (204 in total).

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged from 19 to 85 years
* Confirmed MDR-TB or RR-TB
* On current TB therapy for ≤14 days at the time of enrollment.

Exclusion Criteria:

* Known any quinolone-resistant MDR-TB
* Known XDR-TB
* who are pregnant or who are unwilling to use proper contraceptives at childbearing age
* Medical history of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* The need for ongoing use of prohibited drugs while on study drugs
* History of optic neuropathy or peripheral neuropathy
* With any of the following test results: i.Absolute neutrophil count \< 2000 cells/mL, ii.White blood cell count (WBC) \< 3.0 X 103/µL, iii.Hemoglobin \< 7.0 g/dL, iv.Serum creatinine \> 2.0 mg/dL, v.Aspartate aminotransferase (AST or SGOT) \>100 IU/L, vi.Alanine aminotransferase (ALT or SGPT) \>100 IU/L, vii.Total bilirubin \> 2.0 mg/dL, viii.Albumin \< 2.8g/dL, ix.QTcF \> 500ms
* History of hypersensitivity reaction to the study drugs
A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide 1 mg by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)

This study compares semaglutide in two different injection tools called "PDS290" and "DV3372". The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools. The researchers also want to look at how well the injection tools work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection tool. This is decided by chance, like flipping a coin. This is called randomisation. Semaglutide is an approved medicine (thus available on the market) for people with type 2 diabetes. Semaglutide will be injected subcutaneously (injection under the skin). Participants will get a total of 5 injections with semaglutide. The study will last for a maximum of 86 days. Participants will have 17 scheduled site visits with the study physician or study staff at the study centre. For one of the visits participants will stay at the research unit for 4 days and 3 nights. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men and women are allowed to take part. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria: - Male or female, aged 18 to 55 years (both inclusive) at the time of signing informed consent. - Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive) and weight between 55.0 and 90.0 kg (both inclusive). - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. - Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. - Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol (not allowed within 24 hours before screening), within 14 days prior to the day of screening. - Abuse or intake of alcohol, defined as any of the below: 1) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits) or 2) Positive alcohol test at screening. - Abuse or intake of drugs, defined as any of the below: 1) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening or 2) Positive drug of abuse test at screening.
Alkalinization by Urologists & Nephrologists

Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.

Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases, nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral alkalinization could be performed or by bicarbonate contained in alkaline-based waters or drug therapies or by citrate. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure, especially due to the amount of daily sodium load. No prospective data has been published in clinical routine, studying its effects on extracellular volume nor the blood pressure control.

Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. Initial recorded data will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration), body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up will be: the adherence to treatment, body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, adverse events, blood and urine composition.

The principal criterion of evaluation will be the variation in the extracellular compartment.

Eligibility Criteria:
Inclusion Criteria:

* \> or = to 18 years old
* in whom an oral alkalinization is indicated

Exclusion Criteria:

* if the patient mentions its opposition to his/her enrollment
Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy

The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* experiences at least one nightmare per week for the past month
* having previously experienced a traumatic event
* difficulty falling or staying asleep
* suicidal ideation
* actively under the care of another health care provider

Exclusion Criteria:

* untreated obstructive sleep apnea
* acute or apparent psychosis
* untreated or unstable bipolar disorder
* past history of seizure disorder or neurological disorder
* intellectual disability
* current substance dependence or in past 6 months
Dronabinol Interactions With Cognitive Enhancing Drug in Humans

Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals.

We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.

The impairment of episodic memory in marijuana abusers has important treatment implications. Since many treatments, including cognitive-behavioral therapy, strongly utilize episodic memory, marijuana use during treatment may lead to diminished treatment outcomes. In addition, lessened response inhibition may lead to elevated rates of drug relapse while in treatment. Consequently, a treatment which will improve episodic memory and response inhibition may lead to improved treatment outcomes in marijuana users. One such treatment is modafinil.This study will be a 4 session within-subjects, double-blind, crossover study evaluating the impact of modafinil (400 mg/day) on the cognitive, subjective, and physiological effects of marijuana. Across 4 sessions, subjects will be randomly assigned to receive either oral placebo, modafinil (400mg), dronabinol (15mg), or dronabinol and modafinil. Outcome measures will include physiological, cognitive, and subjective drug effects.

Currently this study complete and has been published.

Eligibility Criteria:
Inclusion Criteria:

* • Males and females between 18 and 55 years old will be eligible for this study.

  * Marijuana used at least once in last 2 months and at least 10 times in lifetime.
  * Subjects do not meet DSM-IV criteria for marijuana abuse or dependence.
  * Subjects are NOT seeking treatment for substance abuse or dependence.
  * Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods other than oral contraceptive pills (OCP). Modafinil may cause OCP to be ineffective. Acceptable forms of birth control are condoms, diaphragms, and IUDs.
  * No alcohol or drugs 24 hours prior to testing session.
  * Subjects must agree to not drive to or from session.

Exclusion Criteria:

* • History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.

  * History of severe renal or hepatic diseases.
  * History of psychosis, schizophrenia or bipolar type I disorder.
  * History of seizure disorder.
  * Current diagnosis of alcohol and other drug dependence (other than nicotine).
  * A positive urine toxicology result for cocaine or opiates at intake.
  * Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
  * Liver function tests (ALT or AST) greater than 3 times normal.
  * Known allergy to modafinil or dronabinol.
Neuropsycholgy and Neuroimaging in Transient Global Amnesia

The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.


Eligibility Criteria:
Inclusion Criteria:

* All the participants

  * Minimum of 7 years of education
  * French native speaker
* Healthy subjects : Non pathological Dementia rating scale score
* Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion

Exclusion Criteria:

* Chronic neurological disease
* Encephalitis
* Endocrinal disease
* Hepatic disease
* Case history of head injury with loss of consciousness of more than one hour
* Case history of stroke
* Case history of cancer during the five last years except squamous cell carcinomas
* Alcoholism or drug addiction
* Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders
Neurofeedback Training for Dyslexia

The study aims at testing a Neurofeedback (NF) training specifically designed for inducing a functional hemispheric imbalance of the tempo-parietal regions in individuals with dyslexia. A randomized clinical trial aimed at comparing two experimental conditions is described: a) Left theta/beta NF training in combination with right beta/theta NF training and b) sham NF training.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dyslexia or reading performance 2 SD below the norm
* Average intelligence

Exclusion Criteria:

* Psychiatric conditions
* Comorbidity with neurodevelopmental disorders
* Neurological disorders
* Epilepsy
* Enrollment in linguistic or literature university courses