cyrilzakka/clinical-trials huggingface dataset:
Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease

The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms


Eligibility Criteria:
Participant:

Inclusion Criteria:

* confirmed HD mutation carriers
* early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
* exhibit mild to moderate behavioral symptoms, such as clinically diagnosed apathy, irritability, anxiety, depression, aggression and repetition
* stable doses of medications for at least one month

Exclusion Criteria:

* unstable medical conditions
* history of epilepsy
* metallic objects in the brain
* clinical diagnosis of major cognitive disorder or dementia
* Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4

Caregiver:

Inclusion Criteria:

-willingness to participate in the study

Exclusion Criteria:

-motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.
Development of Maternal Voice Recognition in Preterm Neonates

Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition, tend to be processed by the right hemisphere. Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the presence of anatomical and functional asymmetries by the first months of life. What are the causes of these asymmetries? How do they develop? Are they necessary for functioning or effective learning?

This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of development at which hemispheric dominance for voice recognition is first observed and to identify the brain structure involved in preterm neonates whose sound environment is usually very different from that of the foetus. The impact of this environment on the infant's brain development and early learning will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The distribution of children in the different groups of infants included in the study will be validated at the time of the acquisitions.
* Normal group of children: A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF, Scanner, MRI).
* Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF, Scanner, MRI).

Exclusion Criteria:

About history:

* All children with severe congenital malformation

Regarding the study period;

* Any refusal of a parent
* Children with severe impairment of the general condition and vital functions
* Children with dermatitis of the face or scalp
* Children treated with ventilation High Frequency (HFO)
* Presence of intravenous access on the scalp (preventing the realization of the ETF, EEG and NIRS
The Effects of Joint Effusion on Proprioception

The purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee osteoarthritis (OA).

Proprioception is a sensory modality that provides feedback on the internal status of the body and enables us to perceive joint position and motion.

Osteoarthritis (OA), also called degenerative joint disease, is a major musculoskeletal condition characterized by loss of articular cartilage that leads to pain and loss of function. The most commonly affected joint is the knee, and OA may result in changes that affect not only intracapsular tissues, but also periarticular tissues, such as ligaments, capsules, tendons, and muscles. Many studies have examined the proprioceptive status of knee OA, and subjects with knee OA are known to have impaired proprioception compared with age-matched controls.

Joint effusion is a common symptom associated with chronic degenerative joint condition, but the effects of effusion on knee joint proprioception have not been investigated in detail.

A volume of 20 mL of normal saline was injected into the knee joint cavity of subjects in the experimental group under ultrasonographic guidance. Proprioceptive acuity was assessed by active repositioning of the lower limb using an electrogoniometer to measure knee joint position sense (JPS) under both non-weight-bearing and weight-bearing conditions twice, with a 20-min rest interval.

Eligibility Criteria:
Inclusion Criteria:

Or at least two of criteria 2-6 established by the American College of Rheumatology (ACR):

1. Kellgren and Lawrence (K/L) grade ≥II
2. morning stiffness \<30 min in duration
3. crepitus on movement of the knee joint
4. bony tenderness at the knee joint margins
5. palpable or visible bony enlargement
6. no palpable warmth.

Exclusion Criteria:

1. the presence of knee joint effusion determined by ultrasonography
2. a history of knee injury or surgery
3. a history of knee injection within 3 months
4. a history of inflammatory arthritis
5. taking anticoagulants
6. balance or gait disturbance
7. diabetes mellitus.
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18-55 (inclusive) years
* Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
* Non-smoking (by declaration) for a period of at least six months prior to screening visit

Exclusion Criteria:

-
A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills

To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.

In this study, the patients were divided into exposed and non-exposed groups based on whether or not they were taking Liuwei Dihuang Pills.

The patients in the non-exposed group were treated routinely, and the patients in the exposed group were treated routinely + Liuwei Dihuang Pills. The patients in the exposed group were required to take the medication according to the dosage instructions for at least 4 consecutive weeks. Combined use of drugs is allowed without interfering with the treatment plan, and the use of drugs and combined use of drugs should be recorded truthfully, including the dose, duration, frequency, and so on. The type of drugs used in combination and the corresponding daily dose, daily frequency and duration of treatment. During the course of treatment, patients in both groups were required to receive follow-up assessment once every 4 weeks. Termination of the study included death, loss of patients, or achievement of study endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 45-55 years old
2. Patients with menopausal syndrome using Liuwei Dihuang Pills
3. Kidney Yin Deficiency Syndrome

Exclusion Criteria:

1. Individuals allergic to any components of the drug or excipients;
2. Individuals with other endocrine diseases;
3. Individuals with organic lesions of the reproductive system;
4. Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;
5. Individuals with endometrial hyperplasia or unexplained vaginal bleeding;
6. Individuals with malignant tumors, hematologic, or immune system diseases;
7. Individuals with severe cardiovascular, cerebrovascular, liver, or kidney diseases (e.g., serum transaminase levels more than 1.5 times the upper limit of normal, serum creatinine above the upper limit of normal);
8. Individuals with psychiatric disorders or dependence on alcohol or drugs;
9. Individuals with mental illness or communication barriers;
10. Individuals with other conditions that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate the study process are not suitable for participation in this clinical research.
Behavioral Self-activation and Virtual Reality in Depression

Depression is a major handicap in daily life and is often treated by behavioral activation (CA), including the Brief Behavioral Activation Treatment for Depression (BATD).The CA principle is to set up activities, in keeping with the values of the individual. Other tools associated with the CA deserve to be explored as virtual reality (VR), which offers scenarios and sensations similar to real life and a sense of life. in a safe and controlled environment, with the support of the therapist.The main objective is to compare the effectiveness of the program "BATD with RV" versus "BATD without RV" on the intensity of the depressive symptomatology and CA in everyday life.

Methodology: This is a randomized, blinded study. Inclusion criteria are: 18 to 70 years old; unipolar depression diagnosis; Showing a score of ≥ 17 on the BDI-II. 80 subjects will be recruited over 24 months and randomized into 2 groups: 1) intervention group program BATD in VR; 2) BATD program intervention group without RV, lasting 45 minutes.

Judgment Criteria: The effectiveness of the intervention will be evaluated by the BDI-II scale and the Behavioral Activation for Depression Scale (BADS).

Outcomes: A new management of depression (AC with RV) to improve the quality of life of the patient; proof of its effectiveness; a generalization of this care; and recognition of its effectiveness in the scientific community.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 to 70,
2. Having a diagnosis of unipolar depressive disorder characterized (diagnostic criteria of depression of DSM-V),
3. Primary depression and not secondary to another disorder (eg social phobia, OCD, severe personality disorder, ASD, TCA, ect.)
4. Showing a score greater than or equal to 17 points on the IDB-II,
5. Followed by a psychiatrist from the University Hospital of Montpellier or a liberal,
6. Can read, understand and speak French,
7. To be affiliated or beneficiary of a social security scheme.
8. Collection of informed consent.

Exclusion Criteria:

(1) History of head trauma or recent central neurological conditions only (2) Current treatment by seismotherapy or rTMS or CBT. (3) Exclusion from all substance-related disorders except tobacco-related disorder (DSM-V)

-
Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS

Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults. It is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The discovery of complement alternative pathway as a major risk factor for aHUS has led to the design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab. Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS patients with a dramatic decrease in the risk of end-stage renal disease. However, the optimal duration of eculizumab therapy is still debated. The present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with aHUS.

A visit (physical examination; blood pressure measurement) will be performed every month for 3 months, and every 3 months for 21 months.

Blood (serum creatinine, platelet count, hemoglobin, LDH, haptoglobin) and urine (proteinuria/creatininuria ratio and microscopic hematuria) tests will be performed every 2 weeks from inclusion to M6 and subsequently every month starting M7 Urine dipstick (for albuminuria and microscopic hematuria) will be performed by the patients at home at least twice a week.

Markers of complement activation and biomarkers of endothelial cells activation and immune cells activation will be assessed at baseline, M1, M3, M6, M9, M12, M18 and M24.

Eligibility Criteria:
Inclusion Criteria:

1. Children and adults under eculizumab treatment for aHUS (initial episode or relapse) defined by at least two of the following: thrombocytopenia (platelet count \< 150 G/L), mechanical hemolytical anaemia (Hb \< 10 g:dl, LDH \> upper limit of normal, undetectable haptoglobin, presence of schizocytes on blood smear), acute kidney injury (serum creatinine and/or proteinuria/creatininuria \> upper limit of normal for age or an increase \> 15% compared to baseline levels )
2. Patients not requiring dialysis.
3. Adults: HUS remission and normal or stabilized renal function under eculizumab treatment since at least 6 months (3 months in patients with MCP mutations)
4. Children: age \> 3 years at eculizumab withdrawal; HUS remission and normal renal function under eculizumab treatment since at least 3 months in children with isolated MCP mutation, at least 6 months in children with complement mutation other than MCP.

Exclusion Criteria:

1. Patients on dialysis.
2. Women treated with eculizumab starting or planning a pregnancy. Pregnancy including the post-partum period is high-risk periods for the occurrence of aHUS.
3. Patients who did not give informed consent.
4. Patients under protection of a judicial authority

Patients can be enrolled in the study within ten weeks after Eculizumab stop.
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.

Opioid-dependent patients can develop hyperalgesia and often have a high opioid consumption postoperatively due to opioid tolerance. Intraoperative ketamine in subanesthetic doses can possibly reduce hyperalgesia and reduce opioid-tolerance in these patients. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nerve system. It can be used for general anesthesia but the drug also has other properties including lowering of central excitability and reducing postoperative opioid tolerance by modeling the opioid receptors. Further more it can possibly reduce chronic pain by blocking wind-up effect when blocking the NMDA receptors.

Our purpose is to investigate the effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients. Our hypothesis is that ketamine can reduce opioid consumption and reduce postoperative pain and side effects compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar spinal fusion surgery in general anesthesia.
* Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidone, oxycodone, fentanyl, tramadol and/or buprenorphine).
* Back pain for a minimum of 3 months preoperatively.
* Age \> 18 years and \< 85 years.
* ASA 1-3.
* BMI \> 18 and \< 40.
* Fertile women need to have a negative urine HCG pregnancy test.
* Patients who have given their written informed consent to participate in the study after understanding the content and limitations of the study

Exclusion Criteria:

* Participation in another concomitant drug trial.
* Patients who do not understand or speak Danish.
* Allergy to the drugs used in the trial.
* Abuse of drugs - as assessed by the investigator.
* Daily methadone use.
* Increased intraocular pressure - assessed from the patients chart.
* Uncontrolled hypertension - assessed from the patients chart.
* Previous and current psychotic episodes - assessed from the patients chart
Dose-Escalation Study in Advanced Colon Cancer Patients

This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
2. Age ≥ 18 years
3. Life expectancy ≥ 12 weeks
4. WHO performance status of 0-1
5. Negative serum pregnancy test
6. Adequate hepatic or renal function and hematological parameters

Exclusion Criteria:

1. Brain metastases
2. Ileostomy or colonostomy
3. History of pelvic radiotherapy
4. Grade \> 1 diarrhea at baseline

Other protocol-defined inclusion/exclusion criteria may apply
Low Dose Irradiation for Small Bowel Transplant

The specific aims of this study is to improve short and long-term patient and graft survival, to reduce the incidence and severity of allograft rejection, to reduce the incidence of infection and to reduce and/or eventually eliminate the need for long-term immunosuppression.

The rationale behind this study involves the need to better manage rejection in the intestinal allograft recipient. Although tacrolimus based immunosuppression has made intestinal transplantation feasible, the requisite need for chronic high dose immunosuppression in order to control rejection has inhibited the wide spread clinical use and practicality of intestinal/multivisceral transplantation. The measures needed to prevent graft loss have frequently resulted in lethal infections, the leading cause of death. This trial is significant for determining if this new strategy of allograft immune-modulation with low dose ex-vivo irradiation and simultaneous done bone marrow cell infusion will favorably affect short and long term outcomes by reducing the risk of allograft rejection.

This trial is offered to all patients with irreversible intestinal failure who must undergo intestinal, combined liver-intestinal, and multivisceral transplantation at the University of Pittsburgh Medical Center. Patients are recruited through the referral system and no cold calling is carried out. Patient confidentiality is maintained by the use of codes to identify the study participants. All data is stored in a locked filing cabinets as a means to protect participants against a breach of confidentiality. This trial involves ex-vivo low dose irradiation of the intestinal allograft with or without adjunct donor bone marrow cell infusion. An intravenous bone marrow cell infusion is prepared form the thoracolumbar vertebral bodies harvested from cadaveric donors. Control subjects will be those who refuse to be enrolled in the study or those for whom donor bone marrow is not available. All patients will be treated perioperatively with thymoglobulin, a rabbit polyclonal anti-lymphocyte globulin at a dose of 5-10 mg/kg. Tacrolimus will be given in a standard fashion and from the outset as a single monotherapeutic agent to prevent early allograft rejection and promote graft acceptance. All patients will be monitored for rejection, graft function, opportunistic infections and GVHD. Surveillance endoscopy with guided mucosal biopsies will be obtained according to the standard protocol. Attention will be paid for any clinicopathologic changes suggestive of acute or chronic irradiation injuries.

The study closed for enrollment as of 9/30/03.

Eligibility Criteria:
Inclusion Criteria:

* all patients between 17 and 70 who are diagnosed with intestinal failure awaiting intestinal/multivisceral transplant

Exclusion Criteria:

* active systemic/abdominal infections
* incurable malignancy
* acquired immune deficiency syndrome
* severe cardiopulmonary insufficiency
* current alcoholism
* pregnant female
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes

The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to \<12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.

The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to \<12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.

Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.

Eligibility Criteria:
Inclusion criteria

* Prepubertal children 2 to \<12 years old (i.e., before 12th birthday)
* Type 1 diabetes for at least 6 months
* Patients must be using insulin pump therapy
* Not presently on low carbohydrate diet

Exclusion criteria

* On low or very low carbohydrate diet
* History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
* History of metabolic disorder affection lipid metabolism
* Severe hypoglycemic event in past 3 months