cyrilzakka/clinical-trials huggingface dataset:
Effect of a Robotic Platform for Hip Fracture Rehab

Hip fracture is one of the most common traumas associated with falls in the elderly, severely affecting the patient's mobility and independence. The treatment involves hospitalization and prolonged rehabilitation periods with high costs which are associated with an increased mortality rate due to health complications. In recent years, the use of robotic applications has proven to be effective in gait rehabilitation, especially for neurological disorders. However, there is a lack of research in robotic rehabilitation focused on the hip fracture of elderly people. This study presents the validation of a novel robotic platform for hip rehabilitation called SWalker aimed at improving the rehabilitation of this condition in comparison with conventional rehabilitation.

The performance of the SWalker platform was assessed at Albertia Servicios Sociosanitarios S.A. nursing homes. Clinical validation was conducted with hip fracture patients. The control group consisted of patients who followed conventional therapy, while the intervention group consisted of patients rehabilitated using SWalker. Allocation to groups was according to the choice of the participants. All patients had the possibility to use SWalker treatment. Physiological parameters, and functional assessment scales such as FAC and Tinetti were collected at the beginning and at the end of the intervention. Gait recovery and rehabilitation process indicators were also gathered. The total duration of the clinical validation was 15 months. For each patient, the total duration of treatment was between 1 week and 1 month with the robotic platform. For those patients who received conventional rehabilitation, treatment duration was up to 6 months in the most severe case. Patient follow-up was conducted in parallel with the clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients who, after recently having undergone a hip fracture surgery, needed subsequent rehabilitation to restore autonomous ambulation
* patients over 65 years of age

Exclusion Criteria:

* patients who have undergone a hip fracture surgery more than 5 months ago
* patients who have already received other types of hip fracture rehabilitation therapies
* patients with advanced and limiting neurological and cognitive impairment
Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines

A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501B in Glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)

Exclusion Criteria:

* Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
* History of facial nerve paralysis or ptosis
* Significant facial asymmetry
* Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
* Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
* Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)
Expanded Access to NanoDoce

NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients

The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training

Participants will:

* Take 12 sessions of the MMGT program over six weeks
* With each session lasting 45 minutes, including 10-minute rest breaks.


Eligibility Criteria:
Inclusion Criteria:

* Participants of age between 45 and 70 year
* Participants of both genders were included.
* Participants who were able to walk independently indoors without walking aid
* Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34
* Participants with stroke lasting longer than six months
* Participants with Mini-Mental Status Examination score 24 or more than 24
* Participants with the capability to keep in sitting position for 30 minutes
* Participants with the history of fall in the past year
* Participants with no visual or auditory impairments that would interfere with the training

Exclusion Criteria:

* Participants with respiratory problems.
* Participants with any orthopedic condition.
* Participants with aphasia that impeded communication.
* Participants with have severe cardiac disease.
* Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)
* Participants with presence of non-healing ulcers in the lower limbs, and osteoporosis
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib

This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).


Eligibility Criteria:
Inclusion Criteria:

* Within body mass index (BMI) range 18.5 to 32.0 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations (including chemistry panel \[fasted at least 8 hours\], hematology, and urinalysis \[UA\] with complete microscopic analysis within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator)
* Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -2)
* Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the Investigator)
* History of diabetes requiring insulin or fasting glucose ≥160 mg/dL
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
* history of stomach or intestinal surgery or resection, or other GI disorder that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
* history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant
Investigating Genetic Risk for Type 1 Diabetes

The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase II b primary prevention trial.

This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old).

Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.

The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (\>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.

Eligibility Criteria:
Inclusion Criteria:

* Parent/guardian of participant is willing and able to give informed consent for participation in the study.
* Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.

Exclusion Criteria:

* Parent/legal guardian unwilling or unable to give written informed consent to participate in the study
* Unable to understand written or verbal English which would preclude them from understanding the study
Post-dural Puncture Headache: A Retrospective Study

Neuraxial techniques are widely used in obstetric practice to provide analgesia and anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during insertion of an epidural needle. Incidence of PDPH after spinal anesthesia is very low due to the widespread use of non-cutting small diameter spinal needles. Incidence of "wet tap" during epidural injection has been reported to be 1.5%, with 52-85% of these patients developing PDPH.

When an obstetric patient develops PDPH, institution of an effective treatment is necessary. Although PDPH tends to resolve spontaneously over a couple of weeks, it carries the risk of potential complications. PDPH interfere with the ability of the mother to take care of her baby, increases the risk of chronic headache and limits early ambulation, thereby increasing the risk of venous thrombosis and pulmonary embolism. As important as treating PDPH when it occurs is to prevent it when the dura is accidentally punctured during labor epidural placement. Multiple therapeutic strategies have been reported in the medical literature to prevent this outcome. Preventive measures range from conservative strategies to invasive procedures. Bedrest and hydration have been traditionally recommended to try to prevent PDPH when a wet tap occurs; however, no conclusive evidence supports their use. The use of oral and intravenous caffeine is insufficiently supported by clinical evidence. Epidural morphine and intravenous cosyntropin have been successfully used to prevent PDPH. Epidural injection of normal saline reduces the gradient for CSF leak. The use of saline has shown variable results in different studies. Although the results of some studies show insufficient evidence about its effectiveness, administration of epidural saline is a technique relatively devoid of significant adverse effects.

The institutional protocol recommends the combination of a multimodal approach to prevention of PDPH after accidental dural puncture, based on strategies reported in the medical literature. The protocol consists of the immediate administration of 60 cc of epidural normal saline, followed by two preventive measures administered after delivery. After delivery, 1 mg of intravenous cosyntropin and 3 mg of epidural morphine before catheter removal are administered. This study tests the hypothesis that the multimodal prophylactic protocol described above decreases the incidence of PDPH and the need to perform epidural blood patch, compared to other strategies or no prophylactic management.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients who underwent labor epidural and had accidental dural puncture

Exclusion Criteria:

* History of migraines or chronic headaches
* History of neurological deficits
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic hepatitis C, genotype 1;
* insulin resistance.

Exclusion Criteria:

* other forms of liver disease;
* cirrhosis;
* previous treatment for chronic hepatitis C;
* insulin treatment during prior 2 weeks;
* type 1 diabetes.
Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale

We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire

The primary objective is to validate the French version of the PEB scale, called "Echelle d'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".

The hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.

Consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.

Eligibility Criteria:
Inclusion Criteria:

* - Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG
* French-speaking and able to understand the study information
* ≥18 years of age

Exclusion Criteria:

* - Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other de-pendent persons
Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer

Objectives: 1) To evaluate the effect of early compression therapy with individualized exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate the effect of early compression therapy with individualized exercise on lower limb volume, quality of life and incidence of cellulitis infections at 12 months post-operatively in this population.

Study design and setting: A pilot randomized controlled trial will be conducted on 50 patients with gynecological cancer recruited from the McGill University Health Centre (MUHC) Royal Victoria Hospital and the Jewish General Hospital (JGH) Segal Cancer Centre in Montreal, Quebec. The data collection and interventions will be conducted at the MUHC Lymphedema Support Centre.

Intervention: At 4-6 weeks post-operatively, each participant in the experimental group will be prescribed Jobst Elvarex compression class 1 (18 to 21 mmHg) standard or custom-made stockings for both lower limbs with or without panty. The participants will be recommended to wear the garments for 12 to 16 hours daily for at least 6 months post-operatively. At this time, the participants will also receive individualized education on exercise, self-lymphatic drainage and skin care by an unblinded lymphedema therapist.

Control: At 4-6 weeks post-operatively (T2), both groups will receive standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec.

Eligibility Criteria:
Inclusion Criteria:

* above 18 years of age;
* diagnosis of grade 2 or 3 endometrial cancer, or high grade type (serous or clear cell), stage 1b1 or stage 2a cervical cancer, stage 1 vulvar cancer with tumor greater than 4 cm, or stage 2 or 3 vulvar cancer;
* to undergo surgical lymph node dissection.

Exclusion Criteria:

* recurrent diagnosis of gynecological cancer;
* presence of distant metastases (stage 4 cancer);
* body mass index of 35 or greater.
Hummingbird TTS Ear Tube Delivery Study

The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo tympanostomy tube insertion.
2. At least 6 months old.
3. Subject is able and willing to comply with follow-up requirements.
4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.

Exclusion Criteria:

1. Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
2. Significantly atrophic tympanic membrane.
3. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
4. Anatomy precludes sufficient visualization and access to the tympanic membrane.
iStent Inject New Enrollment Post-Approval Study

Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 22 years of age
2. Mild to moderate primary open-angle glaucoma
3. Scheduled to undergo cataract surgery
4. Able and willing to attend scheduled follow-up exams for three years postoperatively
5. Able and willing to provide written informed consent on the IRB approved Informed Consent Form

   Operative Inclusion Criterion:
6. Successful, uncomplicated cataract surgery

Exclusion Criteria:

1. Angle closure glaucoma
2. Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
3. Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix

The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old.
* Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
* Patientes in a late stage or with progresive desease.
* One mesurable lesion in irradiated zone.
* Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
* Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.
* Good biologicals and hematologicals fonctions:
* Neutrophiles noless than 1,5.109/L.
* Platelets nolss than 100.109/L.
* Total bilirubin no more than 1,5 time the normal superior range.
* Transaminases no mote than 3 x Time NSR
* Creatinine clairance Cockroft) more than 50 mL/min .
* Inform consent signed.

Exclusion Criteria:

* Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
* Other cancer in the last 5 years exept treated BCC.
* Dermatologic desease.
* Crohn desease or Hemorragic rectal-Colitis.
* Neuropathy.
* Psychologic disorder.
* Social troubles.
* Pregnant women.
Leuven Growing Into Deficit Follow-up Study

The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=\<1year).

Exclusion Criteria:

* Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment
* IQ \< 70
* Lack of baseline neurocognitive measurements during first follow-up
* Date of birth before February 2005
Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II

Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe when endoscopists were not expose to radiation. This study was to evaluate the effectiveness and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in patients with complexity level I/II.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

* 1 Bismuth typy Ⅲ and Ⅳ
* 2 common bile duct stone \> 15mm
* 3 common bile duct stone and distal stenosis